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    Chembio Diagnostics - 10 Mio Umsatz und kaum beachtet - 500 Beiträge pro Seite

    eröffnet am 16.06.08 21:47:05 von
    neuester Beitrag 20.11.08 15:04:56 von
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      Avatar
      schrieb am 16.06.08 21:47:05
      Beitrag Nr. 1 ()
      Hallo zusammen

      Ich beobachte schon seit langem diesen Wert. Nach einem Jahr bergab scheint nun ein Boden gefunden worden zu sein und ein erster kleiner Anstieg ging auch schon.

      Zudem gab es Insiderkäufe im Wert von über 100k!

      In den nächsten Tagen werde ich ein paar Infos hier posten - soweit es meine Zeit zulässt.

      Vielleicht gibt es hier ja auch noch andere, die in dem Wert investiert sind und sich etwas an einer Diskussion beteiligen wollen.

      Hier noch die letzte Einschätzung:



      Dutton Associates Announces Investment Opinion: Chembio Diagnostics Strong Speculative Buy Rating in Update Coverage by Dutton Associates


      Dutton Associates updates its coverage of Chembio Diagnostics
      (OTCBB:CEMI ), maintaining its rating at Strong Speculative Buy and its price target of $.50. The 14-page report by Dutton senior analyst Stephen L. Handley is available at www.jmdutton.com, and at First Call, Bloomberg Professional, Knobias, Zacks, Reuters, and other leading financial portals.

      Chembio´s stock has declined significantly in recent months, from a high of $0.30 in February, with the result that the Company´s equity is now capitalized in the stock market at only about $7 million. We believe this represents a gross undervaluation for a promising early stage company that, we estimate, is likely to post sales in excess of $10 million this year, achieve initial profitability by year end, and has the potential to become a significant factor in several attractive niches of the diagnostics market. The positive outlook, to which we subscribe, is that Chembio clearly has strong positive momentum and, in particular, we believe that it will benefit increasingly from Inverness Medical´s rising sales of the Company´s products as well as from additional external agreements associated with its patented DPP(TM) technology. We acknowledge that our revised target price of $0.50 per share, by the end of 2009, is quite conjectural. This would represent a large percentage advance from currently depressed levels. Nevertheless, at that price the market capitalization would be about $30 million and as such would still undervalue the Company, in our opinion, assuming a profitable annual revenue run rate at that time approaching $20 million.

      About Dutton Associates

      Dutton Associates is one of the largest independent investment research firms in the U.S. Its 30 senior analysts, primarily CFAs, have expertise in many industries. Dutton Associates provides continuing analyst coverage of over 140 enrolled companies, and its research, estimates, and ratings are carried in all the major databases serving institutions and online investors.

      The cost of enrollment in the Dutton Associates one-year continuing research program is US $35,000 prepaid from the Company for 4 Research Reports, typically published quarterly, and requisite Research Notes. Dutton Associates received $51,000 from the Company for 6 Research Reports with coverage commencing on 02/07/2006. Dutton Associates does not accept payment of any of its fees in company stock. Its principals and analysts are prohibited from owning or trading in securities of covered companies. The views expressed in this research report accurately reflect the analyst´s personal views about the subject securities or issuer. Neither the analyst´s compensation nor the compensation received by us is in any way related to the specific ratings or views contained in this research report or note. Please read full disclosures, and analyst background at www.jmdutton.com before investing.


      © Business Wire
      © Business Wire
      Avatar
      schrieb am 16.06.08 22:23:55
      Beitrag Nr. 2 ()
      Umsatz 1000$ pro Tag
      Avatar
      schrieb am 17.06.08 12:06:16
      Beitrag Nr. 3 ()
      Hier die Info zu den Insider-Geschäften (von finance.yahoo.com)

      19-May-08 SIEBERT LAWRENCE A.
      Officer 400,000 Direct Purchase at $0.11 - $0.12 per share. $46,0002
      16-May-08 SIEBERT LAWRENCE A.
      Officer 200,800 Direct Purchase at $0.08 - $0.12 per share. N/A
      15-May-08 SIEBERT LAWRENCE A.
      Officer 400,000 Direct Purchase at $0.08 per share. $32,000
      14-Mar-08 MELLER GARY
      Director 100,000 Direct Purchase at $0.15 per share. $15,000
      14-Mar-08 SIEBERT LAWRENCE A.
      Officer 151,000 Direct Purchase at $0.15 per share. $22,650
      Avatar
      schrieb am 17.06.08 12:07:22
      Beitrag Nr. 4 ()
      ABOUT CHEMBIO

      Chembio Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic tests, participates in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP™) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP™. Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for
      Avatar
      schrieb am 17.06.08 12:22:06
      Beitrag Nr. 5 ()
      Hier noch für Interessierte zwei Links zu Infos von Chembios Homepage

      FactSheet:
      http://library.corporate-ir.net/library/12/121/121584/items/…

      Investor Präsentation
      http://media.corporate-ir.net/media_files/irol/12/121584/Inv…

      Trading Spotlight

      Anzeige
      InnoCan Pharma
      0,1925EUR +3,22 %
      InnoCans LPT-Therapie als Opioid-Alternative?! mehr zur Aktie »
      Avatar
      schrieb am 17.06.08 12:31:03
      Beitrag Nr. 6 ()
      10.06.2008 11:48

      Chembio Diagnostics Systems aussichtsreich (Global Biotech Investing)

      Endingen (aktiencheck.de AG) - Die Experten von "Global Biotech Investing" halten die Aktie von Chembio Diagnostics Systems (ISIN US1635721004 (News)/ WKN A0JMX3) für ein aussichtsreiches Investment im Diagnostik-Bereich.

      Das Unternehmen entwickle diagnostische Schnelltests auf der Basis einer eigenen, patentierten Plattformtechnologie. Kürzlich erst habe man eine Entwicklungskooperation mit Bio-Rad Laboratories gemeldet und zudem habe die Firma mit seinem HIV-Schnelltest bereits ein etabliertes Produkt am Markt.

      Auffällig seien auch die Insideraktivitäten des CEO Siebert Lawrence, der von Mitte März bis Mitte Mai im Gesamtvolumen von 122.000 USD eigene Aktien zu einem Durchschnittskurs von 10,6 US-Cents gekauft habe.

      Die aktuellen Notierungen der Chembio Diagnostics Systems-Aktie liegen gerade mal 20% höher und bieten eine ideale Gelegenheit, es dem Insider umgehend gleichzutun, so die Experten von "Global Biotech Investing". (Ausgabe 11 vom 09.06.2008) (10.06.2008/ac/a/a) Analyse-Datum: 10.06.2008
      Avatar
      schrieb am 17.06.08 15:38:50
      Beitrag Nr. 7 ()
      ...Dank für den Hinweis,werde den Wert mal beobachten ...allerdings,der Chart sieht grausam aus :cry: hier mein Tip für ein spekulatives Investment : PBIO
      Avatar
      schrieb am 17.06.08 17:51:51
      Beitrag Nr. 8 ()
      Stimmt, der Chart schaut natürlich nicht so toll aus.
      Hoffe allerdings, dass der Anstieg jetzt kein Strohfeuer war, sondern der Abwärtstrend nachhaltig durchbrochen werden kann.

      Positiv stimmen mich vor allem die Insider-Käufe - der wird über 100k Dollar bestimmt nicht einfach so investieren...
      Avatar
      schrieb am 18.06.08 08:40:27
      Beitrag Nr. 9 ()
      Chembio hat ja auch Tests für Tiere in ihrem Produktportfolio http://chembio.com/products.html .
      Vergangenen Mai konnte man sich das Unternehmen auf der Messe http://www.eazwv-2008.org/ in Leipzig mal näher anschauen.

      Kommt auch nicht oft vor, dass ein OTCBB-Unternehmen in Deutschland auf einer Messe zu finden ist ;)

      Ansonsten stehen Ende Juli und anfang August wieder interessante Messeauftritte statt wo es dann hoffentlich bald wieder zu neuen Vertragsabschlüssen kommen wird.

      Übersicht der Events:
      http://www.chembio.com/events.html
      Avatar
      schrieb am 20.06.08 21:24:24
      Beitrag Nr. 10 ()
      liest sich gut.
      denke werde mir ein paar ins Depot legen.

      werden die 0,50 $ die obere Grenze sein für CEMI, oder könnte es mehr werden ???

      0,50 $ bis ende 2009, ist lange hin.
      Avatar
      schrieb am 22.06.08 13:50:36
      Beitrag Nr. 11 ()
      Antwort auf Beitrag Nr.: 34.344.930 von Joe_Trader am 20.06.08 21:24:24Hi Joe_Trader
      Schön, dass sich noch ein anderer Interessierter gefunden hat. Ist immer ganz gut, wenn man mal noch eine andere Meinung hört und der wert nicht recht einseitig betrachtet wird.

      Ich denke dem Wert fehlt einfach die Aufmerksamkeit. Wenn man mal schaut wie z.B. eine glif in die Höhe getrieben wird (die haben ja Bluttests für Krebserkrankungen - aber keinerlei nennenswerte revenues - und sind produkttechnisch evtl. ein kleines bisschen vergleichbar), dann müsste eine Chembio noch viel höher stehen.

      Was hier ein wenig Volumen ausmachen kann, hat man an den Insiderkäufen gesehen - da geht es schnell mal um 100% nach oben.

      Solange das Stock-Bonussystem für die Mitarbeiter im Rahmen bleibt und die Revenues sich weiter so gut entwickeln, sieht das hier ganz gut aus.

      Nicht zu vergessen ist auch, dass von den 60Mio shares laut finance.yahoo.com rund 26Mio in festen Händen sind.

      Wenn sich dann vielleicht mal noch ein größeres Unternehmen für die interessiert... - aber das ist nur wunschdenken/spekulation ;)
      Avatar
      schrieb am 22.06.08 13:54:20
      Beitrag Nr. 12 ()
      Antwort auf Beitrag Nr.: 34.348.906 von ollinbg am 22.06.08 13:50:36Nachtrag:
      Einen großen Partner haben sie ja mit Bio-Rad Laboratories, Inc. ("Bio-Rad") (AMEX: BIO) schon - sind 2.3 Milliarden Dollar schwer.

      Vielleicht weckt die Zusammenarbeit ja auch mal das Interesse am kleinen Partner ;)

      Meldung vom April:

      Chembio Signs Exclusive DPP(TM) Development Agreement With Bio-Rad Laboratories, Inc.

      Chembio Diagnostics, Inc. (OTC BB: CEMI) ("Chembio" or the "Company") announced today that it has signed an exclusive development agreement with Bio-Rad Laboratories, Inc. ("Bio-Rad") (AMEX: BIO) and (AMEX: BIOb) to develop a multiplex test employing Chembio's patented DPP(TM) Dual Path Platform test system. The test would also employ certain proprietary reagents belonging to Bio-Rad. The agreement contemplates that the parties would enter into a limited exclusive license to the DPP(TM) technology. Bio-Rad would have exclusive marketing rights for the product.

      According to Chembio Chief Executive Officer Larry Siebert, "This collaboration with a world market leader like Bio-Rad is a good fit for Chembio, as it allows us to leverage our DPP intellectual property with our experience in product development and regulated manufacturing to develop a product to be marketed by a leading diagnostics company."

      ABOUT DPP

      The Dual Path Platform immunoassay is a recent Chembio innovation in the field of rapid testing for which the company received a U.S. patent in 2007. DPP(TM) technology employs two separate and distinct membrane strips, one for the sample migration and one for the test reagents. This unique dual-flow design allows for improved control and management of the sample flow. As a result, the immunological reaction is more efficient than lateral flow tests based upon studies performed by Chembio.

      ABOUT CHEMBIO

      Chembio Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic tests, participates in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third-party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(TM)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(TM). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner, and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Company Contact:
      Chembio Diagnostics, Inc.
      Susan Norcott
      (631) 924-1135, ext. 125
      (www.chembio.com)





      Source: Marketwire (April 16, 2008 - 8:30 AM EDT)

      News by QuoteMedia
      www.quotemedia.com
      Avatar
      schrieb am 24.06.08 19:12:58
      Beitrag Nr. 13 ()
      Hallo zusammen

      Gibt es hier noch mehr Interessierte oder Investierte, die sich an Diskussionen beteiligen wollen?

      Das bid zieht die letzten Tage sehr schön nach - es kommt scheinbar langsam etwas Bewegung rein :)
      Avatar
      schrieb am 25.06.08 16:14:14
      Beitrag Nr. 14 ()
      Irgendwas ist im Busch - schaut lecker aus heute :)
      Avatar
      schrieb am 25.06.08 18:16:21
      Beitrag Nr. 15 ()
      Und der nächste Schritt nach oben - die 20ct. sind durchbrochen :)
      Avatar
      schrieb am 26.06.08 12:08:43
      Beitrag Nr. 16 ()
      Das war doch mal ein ordentlich Tag gestern.
      Das Volumen dreimal so hoch wie der Durchschnitt - bin auf heute gespannt!

      Kein stiller Mitleser hier, der sich mal etwas an einer Diskussion beteiligen will?
      Avatar
      schrieb am 27.06.08 17:04:59
      Beitrag Nr. 17 ()
      News :)


      On National HIV Testing Day Chembio Reports Completion of Pediatric Study Needed for Expanded Product Usage

      Data to Be Submitted to FDA as Supplement to PMA

      MEDFORD, NY, Jun 27, 2008 (MARKET WIRE via COMTEX News Network) -- Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") reported today, National HIV Testing Day, that it has completed a clinical study designed to evaluate the performance of its two FDA (United States Food & Drug Administration) approved rapid HIV tests on a pediatric subpopulation (ages 13-17 years of age). The objective of this study was to ascertain the ability of these tests to detect HIV antibodies in this patient population using various sample matrices -- serum, plasma and fingertip or venous whole blood. The objective of the clinical study was achieved and, pending a satisfactory review of the data by the FDA, Chembio anticipates extending the age range of testing to pediatric subjects that are 13 years of age and above. The trial, conducted at the Laboratory of Viral Diagnostics, University of Maryland School of Medicine, enrolled patients with confirmed HIV-positive status. Additional analyses were performed using standard laboratory reference test methods.
      The results of the clinical study meet the requirements established with the FDA during the design phase of the clinical protocol and will be submitted as a supplement to each of Chembio's two FDA-approved premarket applications (PMAs) covering Chembio's rapid HIV tests being marketed in the United States by Chembio's exclusive U.S. marketing partner.

      Chembio's Chairman and President, Lawrence A. Siebert, commented, "We anticipate that the successful completion of this trial will enable Chembio to expand the age claims of testing with these assays so as to fully meet the U.S. Centers for Disease Control and Prevention (CDC) recommendations that routine screening for HIV be performed on all patients ages 13 to 64 years of age. Routine testing is essential to enable individuals to know their status, to prevent transmission and to improve treatment outcomes, and we are proud to have products that serve this objective."

      ABOUT CHEMBIO

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK(R) line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(TM)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(TM). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner, and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Company Contact:
      Chembio Diagnostics, Inc.
      Susan Norcott
      (631) 924-1135, ext. 125
      (www.chembio.com)



      SOURCE: Chembio Diagnostics, Inc.

      http://www.chembio.com
      Avatar
      schrieb am 27.06.08 20:32:44
      Beitrag Nr. 18 ()
      Kommen gut an die News!

      @Joe_Trader
      Biste noch günstig reingekommen?
      Avatar
      schrieb am 29.06.08 12:13:59
      Beitrag Nr. 19 ()
      Hier gibt es ein sehr interessantes Interview mit Lawrence A. Siebert, President and Director von Chembio zu sehen:

      http://www.onemedplace.com/database/list/cid/2373/

      Ist ja eine richtige Perle unsere Chembio! ;)
      Avatar
      schrieb am 29.06.08 12:26:59
      Beitrag Nr. 20 ()
      Hier noch ein Link zum Produkt, das über Inverness vertrieben wird:
      http://www.invernessmedicalpd.com/poc/products/clr_hiv_compl…
      Avatar
      schrieb am 30.06.08 21:00:17
      Beitrag Nr. 21 ()
      Heute gingen schon mal etwas größere Blöcke über den Tisch.

      Das bid zieht auch erstaunlich gut nach...

      Bid Level #MM's Size Ask Level #MM's Size
      0.2350 1 50 0.2500 1 50
      0.2300 2 100 0.2700 1 50
      0.2000 1 50 0.2750 1 50
      0.1500 1 50 0.2930 1 50
      Avatar
      schrieb am 01.07.08 02:31:42
      Beitrag Nr. 22 ()
      Lesezeichen:D
      Avatar
      schrieb am 01.07.08 20:53:09
      Beitrag Nr. 23 ()
      Antwort auf Beitrag Nr.: 34.408.498 von stargold123 am 01.07.08 02:31:42Hi stargold123
      Schön Dich hier auch zu sehen ;)
      Kannst ja hier auch mal Deine guten Analysen posten ;)



      Die zu 0.25 sind weg:
      Bid Level #MM's Size Ask Level #MM's Size
      0.2400 1 50 0.2570 1 50
      0.2350 1 50 0.2650 1 50
      0.2200 1 50 0.2750 1 50
      0.2000 1 50 0.2900 1 50
      Avatar
      schrieb am 02.07.08 14:39:17
      Beitrag Nr. 24 ()
      Am 8. Juli gibts vielleicht was Interessantes zu hören...


      Chembio to Present at Collins Stewart Emerging Growth Opportunities Conference

      MEDFORD, NY, Jul 02, 2008 (MARKET WIRE via COMTEX News Network) -- Chembio Diagnostics, Inc.'s (OTCBB: CEMI) Chief Executive Officer, Lawrence Siebert, will present at the Collins Stewart Fourth Annual Growth Conference on Tuesday, July 8th at 4:00PM (EDT) at New York City's Mandarin Oriental Hotel.
      A live webcast of the presentation will be available through the following internet link: http://www.wsw.com/webcast/clst/cemi.ob/.

      ABOUT CHEMBIO

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK(R) line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(TM)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(TM). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner, and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Company Contact:
      Chembio Diagnostics, Inc.
      Susan Norcott
      (631) 924-1135, ext. 125
      (www.chembio.com)



      SOURCE: Chembio Diagnostics, Inc.

      http://www.chembio.com
      Avatar
      schrieb am 03.07.08 22:08:15
      Beitrag Nr. 25 ()
      olli!

      ... es kommt mir nur so vor als wenn bei der Kooperation
      Chembio mit BioRad
      eigentlich BioRad die Zügel in der Hand hält, weil BioRad technologisch mehr beiträgt als ChemBio mit DPP, was in meinen Augen nur die Plattform für den Test darstellt, weniger der Test selber.

      Trotzdem viel Erfolg mit dem Investment.
      ChemBio könnte sich als geniale Verkaufsbude herausstellen

      ALDI hat es im Prinzip ja genauso gemacht :cool:
      Avatar
      schrieb am 03.07.08 23:40:26
      Beitrag Nr. 26 ()
      Antwort auf Beitrag Nr.: 34.415.937 von ollinbg am 01.07.08 20:53:09das mache ich nur in meinem Zuhause:D Hier bin ich nur zu besuch:D
      Avatar
      schrieb am 07.07.08 16:13:25
      Beitrag Nr. 27 ()
      Antwort auf Beitrag Nr.: 34.435.415 von stargold123 am 03.07.08 23:40:26Das da wäre?
      Avatar
      schrieb am 07.07.08 22:34:02
      Beitrag Nr. 28 ()
      Antwort auf Beitrag Nr.: 34.451.888 von boxershort am 07.07.08 16:13:25:laugh::laugh::laugh:


      du bist doch der aus 3d:laugh:
      :keks:
      Avatar
      schrieb am 08.07.08 09:54:13
      Beitrag Nr. 29 ()
      Antwort auf Beitrag Nr.: 34.434.891 von talis am 03.07.08 22:08:15Hallo

      gilt das für alle entwickelten Tests? Im Vergleich zu den beiden Mitbewerbern, hat CEMI deutliche Vorteile. Das Problem sind die Kosten für die Produktion und den Verkauf. Die Mitbewerbern wurden ja im 10 Q genannt.

      kennst du noch andere Ags die solche Tests anbieten? Die beiden aus dem Filling sind meines Wissens nicht gelistet.
      Avatar
      schrieb am 08.07.08 15:45:10
      Beitrag Nr. 30 ()
      Hier nochmal als Erinnerung für alle Interessierten - conference call heute!

      Chembio to Present at Collins Stewart Emerging Growth Opportunities Conference
      Chembio Diagnostics, Inc.'s (OTCBB: CEMI) Chief Executive Officer, Lawrence Siebert, will present at the Collins Stewart Fourth Annual Growth Conference on Tuesday, July 8th at 4:00PM (EDT) at New York City's Mandarin Oriental Hotel.

      A live webcast of the presentation will be available through the following internet link: http://www.wsw.com/webcast/clst/cemi.ob/.
      Avatar
      schrieb am 08.07.08 17:54:57
      Beitrag Nr. 31 ()
      Antwort auf Beitrag Nr.: 34.457.636 von stargold123 am 08.07.08 09:54:13stargold,

      gilt das für alle entwickelten Tests?

      das gilt auf jeden Fall für den Aidstest in Kooperation mit BioRad



      das mit den Mitbewerbern muss ich mir mal genauer anschauen


      kennst du noch andere Ags die solche Tests anbieten?

      ich kenne noch Health Discovery (ich habe einen thread dazu), die gehören meiner Meinung nach zum cutting edge, aber noch ohne nenneswerte Umsätze



      was mich an Chembio noch gestört hat sind die hohen Verbindlichkeiten und der Hinweis neues Kapital noch einsammeln zu müssen, dilution mögen wir ja nicht.
      Avatar
      schrieb am 10.07.08 17:03:39
      Beitrag Nr. 32 ()
      Neue Quartalszahlen!

      Sehr erfreulich, wie die Revenues mal wieder gesteigert werden konnten!


      FORM 8-K/A

      Financial Information
      (in $000's) QI 2008 QI 2007 2007 2006
      Total Revenues $ 2,365 $ 2,038 $ 9,231 $ 6,503
      Cost of Sales 1,303 1,378 5,369 4,486
      Gross Profit 1,062 660 3,862 2,017
      Gross Profit % -44.90 % -32.38 % -41.84 % -31.02 %
      Overhead Costs:
      R&D with Regulatory 626 319 1,907 1,401
      S, G&A 1,248 1,252 4,831 5,196
      Total Overhead Costs 1,874 1,571 6,738 6,597
      Operating Income (Loss) (812 ) (911 ) (2,876 ) (4,580 )
      Net Income (Loss) (798 ) (729 ) (2,627 ) (4,995 )
      Pref. Divid. & Beneficial Conv. Features - 354 5,645 3,210
      Net Loss Attrib. To Common Stockholders $ (798 ) $ (1,083 ) $ (8,272 ) $ (8,205 )


      --------------------------------------------------------------------------------

      Selected Balance Sheet Information ($000s) QI 2008
      Cash 1,765
      Total Assets 6,615
      Total Liabilities 2,992

      Shareholders’ Equity 3,624
      Common Stock Outstanding
      (# Shares in 000s) 60,537
      Avatar
      schrieb am 10.07.08 23:31:54
      Beitrag Nr. 33 ()
      Antwort auf Beitrag Nr.: 34.462.912 von talis am 08.07.08 17:54:57ich glaube die Verwässerung wird bei Cemi der Vergangenheit angehören. Die neuen Zahlen sind mehr als OK. Unterm Strich noch ein Verlust, aber die QT 1 sind mm nach ohne die Umsätze des neuen Produktes. Wie auch?. Gestiegene Umsätze, weniger Kosten aus Verkäufen.

      Die R&D wird auch wohl in den nächsten Qts sinken. G&A finde ich noch was hoch? Muss gut bezahlt sein dort zu arbeiten:rolleyes:

      bin eigentlich recht positiv gestimmt

      Die Umsätze könnten mit den beiden alten und dem neuen zum Jahresende eine 0 oder sogar ein kleine Plus geben. Entwicklungskosten, wie gesagt müssen dafür runter und der Umsatz/Absatz in den Staaten muss besser werden. Vielleicht hängt sich der Vertriebspartner wie auf der Konferenz genannt mehr rein.
      Wird ein neues Produkt in Angriff genommen wirds wohl nix mit der 0 oder dem Plus.
      Avatar
      schrieb am 10.07.08 23:37:15
      Beitrag Nr. 34 ()
      Antwort auf Beitrag Nr.: 34.462.912 von talis am 08.07.08 17:54:57ach so habe noch was recherchiert. Cemi ist mit den 2 genannnten Bewerbern (aus dem vorletzten Umsatz Filling) quasi alleine auf dem Markt. Klar gibt es noch andere aber nur 3 sind quasi soweit um richtige Umsätze zu bringen. Vor dem neuen Test war CEMi sogar leicht im Vorteil. Trinity und Orasure haben zwar in einigen Punkten ein tick bessere Werte, aber ins gesamt gesehen liegt cemi vorne. Die beiden andere decken einfach weniger Erkennungsmerkmale ab.
      Avatar
      schrieb am 15.07.08 13:04:17
      Beitrag Nr. 35 ()
      Von vor ein paar Tagen:

      Finanzen.net
      Chembio Diagnostics dranbleiben
      Dienstag 8. Juli 2008, 08:43 Uhr




      Endingen (aktiencheck.de AG) - Die Experten von "Global Biotech Investing" raten, an der Aktie von Chembio Diagnostics (ISIN US1635721004/ WKN A0JMX3) dranzubleiben.
      Der Biotech-Titel habe seit Mitte Mai zu einer Kurserholung auf ein Zwischenhoch von 0,25 USD zugelegt. Doch nach Meinung der Experten dürfte dies noch nicht das Ende der Fahnenstange gewesen sein.

      Denn so seien kürzlich gute klinische Zwischendaten zu einem HIV-Test für Jugendliche veröffentlicht worden.
      Der Test für Erwachsene habe bereits die Marktzulassung erhalten und seine US-Umsätze seien in Q1'2008 um 89% gestiegen. Daher wäre ein Erfolg als Beleg für die Qualität für die Plattformtechnologie von Chembio Diagnostics zu werten. Für diese habe man sogar kürzlich den Bio-Rad-Konzern als Forschungspartner gewinnen können.

      Die Experten von "Global Biotech Investing" empfehlen, an der Aktie von Chembio Diagnostics dranzubleiben. (Ausgabe 13 vom 07.07.2008)
      (08.07.2008/ac/a/a)
      Analyse-Datum: 08.07.2008
      Avatar
      schrieb am 05.08.08 17:55:51
      Beitrag Nr. 36 ()
      Klasse Zahlen und super Aussichten!


      Chembio Reports Record Total Revenues in Second Quarter

      Conference Call Scheduled for Monday, August 4 at 4:30 p.m. Eastern Time

      MEDFORD, NY--(Marketwire - August 4, 2008) - Chembio Diagnostics, Inc. (OTCBB: CEMI) today reported financial results for the three and six months ended June 30, 2008.

      Total revenues for the second quarter of 2008 were higher than any previous quarter at $2.72 million, an 8.6% increase compared with second quarter 2007 revenues of $2.50 million. This revenue growth came from $46,000 of increased product revenues and $169,000 of increased research and grant revenues. The increased product revenues for the second quarter of 2008 included an increase in rapid HIV test revenues of $61,500 to $2.21 million or 2.9% from $2.15 million in the same period of 2007.

      The net loss attributable to common stockholders decreased 63% to $363,000, or $0.01 per share, for the second quarter of 2008 compared to a net loss attributable to common stockholders of $983,000, or $0.08 per share, for the second quarter of 2007. The net loss attributable to common stockholders for the second quarter of 2007 included $357,000 in non-cash dividends to preferred stockholders. As previously reported, all of the Company's convertible preferred stock was converted into common stock in December 2007, which resulted in no preferred stock dividends in the second quarter of 2008.

      Total revenues for the first half of 2008 were $5.08 million, an 11.9% increase compared with first half 2007 total revenues of $4.54 million. First half 2008 revenue growth came from $259,000 of increased product revenues and $283,000 of increased research and grant revenues. The increased product revenues for the first half of 2008 included an increase in rapid HIV test revenue of $171,000 to $4.13 million or 4.3% from $3.96 million in the same period of 2007. In addition, revenues from Tuberculosis tests increased by $59,000 in the first half of 2008 compared with the same period in 2007.

      The net loss attributable to common stockholders decreased 43.8% to $1,161,000, or $0.02 per share, for the first half of 2008 compared to a net loss attributable to common stockholders of $2.07 million or $0.17 per share for the first half of 2007. The net loss attributable to common stockholders for the first half of 2007 included $711,000 in non-cash dividends to preferred stockholders. As previously reported, all of the Company's convertible preferred stock was converted into common stock in December 2007, which resulted in no preferred stock dividends in the first half of 2008.

      Second Quarter and Recent Highlights

      -- In addition to posting record quarterly total revenue, in the second
      quarter of 2008 the Company posted its lowest quarterly operating loss
      since the merger with Chembio Diagnostic Systems, Inc. in May 2004.
      -- Strong sales of rapid HIV tests to Brazil and Africa offset decreased
      sales of these products in the US. The decreased sales in the US are
      due to a slower ramp in US rapid HIV test sales. The slower ramp is
      partially due to the delay in obtaining the approval of our PMA
      supplement to expand our HIV age testing range to include 13 to 17 year
      olds. As reported in June we completed the required clinical study for
      submitting this. In July we submitted the PMA supplement to the FDA,
      and we are now waiting for its review to be completed. This change,
      together with multiple initiatives by our marketing partner to expand
      distribution of our products, and now new studies by the United States
      Centers for Disease Control reported this past weekend of a 40%
      under-reporting of HIV incidence in the United States, should increase
      potential sales opportunities in the U.S. over the long term.
      -- We remain bullish about our potential increased participation in the
      global, as well as domestic, rapid HIV test market. We are pleased with
      the more than tripling of the PEPFAR (U.S. President's Emergency Plan
      for AIDS Relief) program signed into law last week by the President to
      $48 billion over the next five years, and with the increased emphasis on
      testing that is in the new legislation. As the only US-based
      manufacturer of competitively priced rapid HIV tests, we look forward to
      the potential of increased participation in PEPFAR.
      -- Gross Profit increased 30.75% to $1,296,000 reflecting improved average
      unit selling prices and continued improvements in manufacturing
      efficiencies compared to a year ago.
      -- Operating Loss decreased 44% to $365,259 as operating expenses (R&D and
      SG&A) increased less than 1% from the second quarter of 2007.
      -- All studies required to file for CE Marking of our FDA-approved HIV
      tests are now complete. The CE marking certifies that a product has
      met European Union health, safety, and environmental requirements. We
      anticipate submitting the technical file very soon and therefore
      receiving CE marking this year
      -- Our patented DPP® platform is providing the Company with an historic
      number of new product opportunities:
      -- We have completed development of the three DPP® products in
      connection with our contract with the Brazilian Ministry of Health;
      tests for antibody detection of canine Leishmaniasis, Leptospirosis
      and our first multiplex DPP® test, which is a point of care test
      for the confirmation (as compared with screening) of HIV. We are in
      the process of validating these initial products in order to scale
      up their manufacture during the third and fourth quarter. Our current
      forecast is to generate at least $500,000 of product and license
      revenues from these products during the balance of 2008.
      -- We have completed development of our DPP® HIV screening test as a
      result of the successful conclusion of preclinical trials we
      conducted during the second quarter. We are now validating this
      product for production scale-up as well, and finalizing product
      inserts and packaging so that export sales can begin as soon as
      possible. We also are in discussions with potential marketing
      partners for this product in the United States, which would require
      a new PMA submission.
      -- We have made excellent progress on the product development project
      we entered with Bio-Rad Laboratories, Inc. We anticipate completing
      the initial phase of this development during the next couple of
      months, and thereupon proceeding to a long-term development and
      license agreement with Bio Rad.
      -- We are also completing development of our Syphilis screen and
      confirm test and have several new OEM product opportunities under
      discussion for DPP®. We are seeing an increasing interest in the
      combination of our intellectual property with our development and
      manufacturing capabilities.
      -- During the second quarter we also received from the United States
      National Institutes of Health a $296,000 grant for development of a
      DPP® TB test.
      -- The United States Patent and Trademark Office (USPTO) issued Chembio
      an additional patent during the second quarter covering a point of
      care rapid test platform that serves to broaden our intellectual
      property coverage.
      -- The USPTO also issued us the registration of our DPP® trademark,
      enabling increased protection for this intellectual property.

      Lawrence Siebert, President and CEO, commented, "We are pleased at the continued improvements from our base lateral flow business as we approach realizing new revenue streams from our DPP® products. We expect to continue this momentum despite a difficult economic environment as our products serve a global market. On a personal note, I am deeply saddened by the passing of Alan Carus, who was an outstanding and valued member of our Board of Directors and chairman of our Audit Committee since 2005. Al worked tirelessly, was a tremendous asset to Chembio, and he will be sorely missed."

      Conference Call

      As previously announced, Chembio has scheduled a conference call and webcast for 4:30 p.m. Eastern time on Monday, August 4, 2008. Participants may access the call by dialing (877) 407-0782 from the U.S. or (201) 689-8567 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until August 11, 2008 at 11:59 p.m. Eastern Time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S. and entering reservation account number 286 and conference ID 292790. The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=132435. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

      ABOUT CHEMBIO

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third-party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP®) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP™. Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      Forward-Looking Statements

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      (Tables to follow)


      Chembio Diagnostics, Inc.
      Summary of Results of Operations


      For the three months ended For the six months ended
      -------------------------- --------------------------
      June 30, June 30, June 30, June 30,
      2008 2007 2008 2007
      ============ ============ ============ ============
      Total Revenues $ 2,717,784 $ 2,502,773 $ 5,082,512 $ 4,541,093

      Gross Profit $ 1,296,809 $ 991,900 $ 2,358,731 $ 1,651,718

      Operating Loss $ (365,259) $ (654,597) $ (1,176,828) $ (1,565,735)

      Net Loss $ (363,129) $ (625,856) $ (1,161,311) $ (1,354,662)

      Preferred
      Dividends, Deemed
      Dividends and
      Beneficial
      Conversion Feature - $ 356,900 - $ 710,878

      Net Loss
      Attributable to
      Common
      Stockholders $ (363,129) $ (982,756) $ (1,161,311) $ (2,065,540)

      Loss per share $ (0.01) $ (0.08) $ (0.02) $ (0.17)



      Chembio Diagnostics, Inc.
      Summary of Balance Sheet


      June 30, December 31,
      2008 2007
      ============== ==============
      CURRENT ASSETS:
      Cash $ 954,157 $ 2,827,369
      Other current assets 3,195,964 2,643,938
      -------------- --------------
      TOTAL CURRENT ASSETS 4,150,121 5,471,307

      NET FIXED ASSETS 964,542 829,332

      OTHER ASSETS 1,103,970 284,358
      -------------- --------------

      $ 6,218,633 $ 6,584,997
      ============== ==============

      TOTAL CURRENT LIABILITIES $ 2,323,476 $ 2,242,583

      TOTAL OTHER LIABILITIES 570,519 79,588
      -------------- --------------

      TOTAL LIABILITIES 2,893,995 2,322,171

      TOTAL STOCKHOLDERS’ EQUITY (DEFICIENCY) 3,324,638 4,262,826
      -------------- --------------

      $ 6,218,633 $ 6,584,997
      Avatar
      schrieb am 22.09.08 21:38:15
      Beitrag Nr. 37 ()
      Volumentechnisch bewegt sich wieder was. Vielleicht kommen jetzt endlich mal die News zu dem neuen Partner/Geldgeber, der auf dem Conference Call angekündigt wurde.
      Avatar
      schrieb am 02.10.08 17:29:41
      Beitrag Nr. 38 ()
      Endlich wieder tolle News!


      Chembio and Oswaldo Cruz Foundation Sign Agreement for DPP(R) Oral Fluid - Whole Blood HIV Test
      Will Aid Expansion of Prevention Efforts in Brazil
      MEDFORD, NY and RIO DE JANEIRO, BRAZIL, Oct 02, 2008 (MARKET WIRE via COMTEX News Network) -- Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") and the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ") today announced the completion of a technology transfer supply and license agreement for Chembio's DPP(R) HIV 1-2 rapid test for use with oral fluid or whole blood samples. This product has been developed by Chembio with its patented Dual Path Platform (DPP(R)) technology. As previously announced in January, Chembio and FIOCRUZ also executed similar agreements for DPP(R) rapid tests for Leishmania and Leptospirosis, and a third agreement for a multiplex DPP(R) test for the confirmation of HIV-1 that could be performed at the point of care. FIOCRUZ, which is affiliated with the Brazilian Ministry of Health, is its leading supplier for therapeutics, vaccines and diagnostic tests.
      Chembio's DPP(R) test platform was selected for these public health programs because of the high levels of sensitivity and specificity of prototypes evaluated by Bio-Manguinhos. The separate sample application strip and direct binding of HIV antibodies to immobilized HIV antigens enabled by DPP(R) results in improved sensitivity based upon studies conducted by Chembio comparing its product to other FDA-approved rapid HIV tests. Chembio's United States patent was issued in 2007 and patent protection for this technology is pending in a number of other countries, including Brazil. This screening test will help increase the reach and accessibility of HIV testing in Brazil, already a world leader in HIV prevention and treatment efforts, by means of a less invasive oral fluid test.

      Chembio is currently finalizing pre-clinical studies with this same product before commencing clinical trials in support of an FDA PMA application and also plans to seek inclusion of this product in major international programs such as the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).

      Under the terms of the agreement with FIOCRUZ, a minimum of 2.5 million of these tests will be purchased for a period of time, followed by an additional period during which components for tests will be purchased, followed by royalties for a period of five years. The total purchases by FIOCRUZ from Chembio will ultimately be determined by the demand for the product by the national program, the pace of the technology transfer, and FIOCRUZ's manufacturing capacity. Sales are anticipated to begin during 2009 once the products are approved for sale in Brazil, at which time a technology transfer fee will be payable to Chembio. Chembio's 2004 agreement with FIOCRUZ for Chembio's lateral flow rapid HIV test for use with whole blood samples, HIV 1-2 STAT-PAK(R), has been very successful, thus providing the parties with a mutually strong preexisting relationship for this latest agreement and the agreements entered in January.

      Dr. Akira Homma, Director of Bio-Manguinhos, commented: "We believe that it is important to have more sensitive and specific tests that are simple to use and non-invasive based on oral fluid. This will allow us to complement and expand our program that exists as a result of the 2004 whole blood rapid HIV test agreement we entered with Chembio."

      Javan Esfandiari, Senior Vice President of Chembio, commented: "This latest agreement reflects the strong collaborative relationship that we have continued to grow with FIOCRUZ, allowing us to bring innovative technologies to serve global public health needs."

      Lawrence Siebert, Chembio's Chairman and CEO, commented: "We are pleased to launch this important new product based upon our proprietary DPP(R) technology with such an outstanding partner as we have with FIOCRUZ. The option for oral fluid HIV testing is one which we think should be made available globally and Brazil is obviously a very important market to begin this effort, particularly with a leading public health organization of this kind. I appreciate the efforts of all parties to bring this agreement to fruition."

      ABOUT BIO-MANGUINHOS/FIOCRUZ

      Bio-Manguinhos/FIOCRUZ is the largest immuno-biological producer (vaccines, kits for diagnosis of infectious and parasitic diseases, and bio-pharmaceuticals, such as erytropoetin and interferon) in Latin America. With a physical infrastructure comprising nearly 600,000 square feet and a workforce of approximately 1,000, Bio-Manguinhos was created in 1976. The unit is capable of processing over 120 million doses of vaccines per year, supplying up to 30 million doses per year of yellow fever vaccine alone to meet Brazilian and export requirements. In 2006, FIOCRUZ was awarded the Prize for Best Public Health Institution in the world granted by the World Federation of Public Health. Up to 2.5 million kits are produced each year through agreements with the Health Surveillance Secretariat and the National Program on Sexually Transmitted Diseases and Aids, both from the Ministry of Health. In 2004, Bio-Manguinhos entered into a technology transfer, supply and license agreement with Chembio for one of Chembio's rapid HIV tests, and in January 2008, entered into similar agreements for DPP(R) rapid tests for Leishmania and Leptospirosis, and a third agreement for a multiplex DPP(R) test for the confirmation of HIV-1 that could be performed at the point of care.

      ABOUT CHEMBIO DIAGNOSTICS

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK(R) line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(R)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(R). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Contacts:

      Susan Norcott
      Chembio Diagnostics, Inc.
      631-924-1135 x125
      snorcott@chembio.com



      SOURCE: Chembio Diagnostics, Inc.

      mailto:snorcott@chembio.com
      Avatar
      schrieb am 08.10.08 16:02:46
      Beitrag Nr. 39 ()
      NEWS!!!

      Chembio Receives FDA Approval for Extended Age Range for HIV Rapid Tests

      Approval for 13 Year-Olds and Above Fully Meets CDC Recommendations for Routine HIV Testing

      MEDFORD, NY, Oct 08, 2008 (MARKET WIRE via COMTEX News Network) -- Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") has obtained approval from the United States Food and Drug Administration to extend the testing age range for its HIV rapid point-of-care tests to individuals 13 years of age and older. Lowering the testing age claim from 18 years of age to 13 is consistent with the latest United States Centers for Disease Control ("CDC") recommendations that routine screening for HIV be performed on all patients 13 to 64 years of age.

      A clinical study was designed to evaluate the performance of the company's FDA-approved rapid tests, marketed exclusively in the United States by Inverness Medical Innovations, Inc. as Clearview(R) COMPLETE HIV 1/ 2 and Clearview(R) HIV 1/ 2 STAT-PAK(R). The Laboratory of Viral Diagnostics, University of Maryland School of Medicine, performed the study for Chembio on four separate specimen matrices from each study participant: fingerstick capillary whole blood, venous whole blood, serum and plasma. The participants each had a confirmed, known HIV positive status. Based upon the results of the studies and other related information provided to the FDA, the PMA supplement was approved to expand the indications of use section to include the pediatric sub-population 13-17 years of age.

      Of the more than 1 million adults and adolescents estimated to be living with HIV infection in the United States, approximately 232,700 (21%) are unaware of their infection. In 2006, 56,500 (5%) of the people living with HIV were between the ages of 13 and 24.(1) These individuals cannot receive appropriate treatment for their HIV disease and may unknowingly continue to transmit the virus to others. In September 2006, the US Centers for Disease Control (CDC) changed its recommendations to include that all people in the United States between the ages of 13 and 64 years be routinely tested for HIV in healthcare settings. This testing can be performed in primary care facilities, emergency rooms, and clinics for substance abuse and pregnant women. Several states have now begun to implement these recommendations. Embracing these recommendations, California recently enacted a law that will require (as of January 1, 2009) private health insurance companies in the state to cover the cost of HIV testing regardless of whether the testing is related to a primary diagnosis.

      From a public health perspective, the shift in the CDC recommendations from risk-based to routine "opt-out" testing is anticipated to lower the rate of new HIV infections. For individuals, early testing is essential to provide earlier access to care with a greatly improved prognosis. The objectives of the recommendations are many and include increasing HIV screening of patients, fostering earlier detection of infection, identifying and counseling persons with HIV infection and connecting them to clinical and prevention services, and further reducing transmission of HIV in the United States.(2)

      Lawrence Siebert, Chembio's Chairman and CEO, commented, "We are pleased that our rapid HIV tests can now be used for the full range of individuals that should be routinely tested for HIV as recommended by the CDC. This will increase the opportunity for testing and early diagnosis and could subsequently lower infection rates as patients become aware of their HIV status."

      (1) CDC. HIV/AIDS Surveillance Report, 2006. Vol. 18. Atlanta: US Department of Health and Human Services, CDC; 2008. http://www.cdc.gov/hiv (2) CDC. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. MMWR 2006; 55:1-17.
      ABOUT CHEMBIO DIAGNOSTICS

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed exclusively in the U.S. by Inverness Medical Innovations, Inc. Chembio markets its HIV STAT-PAK(R) line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and Chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(R)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(R). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Contacts: Susan Norcott Chembio Diagnostics, Inc. 631-924-1135 x125 snorcott@chembio.com
      SOURCE: Chembio Diagnostics, Inc.

      mailto:snorcott@chembio.com
      Avatar
      schrieb am 20.11.08 15:04:56
      Beitrag Nr. 40 ()
      Antwort auf Beitrag Nr.: 35.478.977 von ollinbg am 08.10.08 16:02:46Chembio Ships First DPP(R) Tests
      Milestone Reached With Patented Technology
      MEDFORD, NY -- (Marketwire) -- 11/20/08 -- Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") has completed the first shipment of products based upon its patented Dual Path Platform or DPP® product technology. This shipment represents a significant milestone for the Company's strategy to develop OEM and branded products utilizing its Dual Path Platform technology and its development, regulatory and manufacturing capabilities.

      This initial DPP® product is a rapid whole blood test for Canine Visceral Leishmaniasis which Chembio developed pursuant to one of the four technology transfer, supply and license agreements that Chembio executed this year with the Oswaldo Cruz Foundation ("FIOCRUZ") of Brazil. The initial shipment of approximately $120,000 is part of an initial order for this product of approximately $500,000, the balance of which the Company anticipates shipping prior to year-end.

      Leishmaniasis is caused by a parasite that is transmitted by an insect vector. Two million new cases of leishmaniasis are estimated to occur annually, with an estimated 12 million people presently infected worldwide. Brazil in particular has experienced a sharp increase in the number of cases. Current eradication programs in Brazil are focused on vector canine populations. Dogs kept in the domestic environment are the principal animal reservoirs in Brazil, and children under the age of 15 years are the most severely affected age group. Currently used laboratory-based diagnostic technologies are impractical for determining whether these dogs are infected and therefore inevitably delay quarantine or other remedial actions upon such determination, hindering eradication efforts. Chembio's DPP® rapid test allows such determination and action to be taken at the point-of-use. The Chembio test is also more accurate than the existing laboratory technologies and rapid tests that are available.

      As previously reported, Chembio has three other agreements in place with FIOCRUZ that were signed this year, including the most recently signed agreement for Chembio's DPP® HIV 1/2 test for use with oral fluid samples.

      Chembio CEO Lawrence Siebert commented, "We are very pleased with the achievement of this milestone. Our patented technology enables immediate results, thereby lowering costs and improving outcomes. We are excited about the opportunities we have for this technology and I am most appreciative of the efforts that our entire staff has made in achieving this initial DPP® product shipment."

      ABOUT CHEMBIO DIAGNOSTICS

      Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP®) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP®. Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

      FORWARD-LOOKING STATEMENTS

      Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

      Contact:
      Susan Norcott
      Chembio Diagnostics, Inc.
      631-924-1135 x125
      snorcott@chembio.com





      Source: Marketwire (November 20, 2008 - 8:50 AM EST)


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