Applied Imaging (903769) Nasdaq + 30% - 500 Beiträge pro Seite

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FDA-Zulassung!!!!!!!!

Applied Imaging Announces FDA Clearances to Market Genetic Probe Test

2005-01-14 08:00 ET - News Release


SAN JOSE, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Applied Imaging Corp. today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its automated application for Chromosome X and Chromosome Y analysis in bone marrow transplant patients. Applied Imaging`s CytoVision(R) system will utilize this application to enumerate tests that are important indicators in evaluating the viability of opposite-sex bone marrow transplants.

Bone marrow transplantation is an important therapeutic strategy in the management of a number of leukemias and other blood-based cancers. This new CytoVision(R) application uses fluorescence in situ hybridization (FISH) technology to identify rapidly and accurately the chromosomal gender of bone marrow cells within a patient sample. A comparison of the proportion of cells belonging to the bone marrow donor versus the recipient is used to evaluate engraftment success in recipients of sex-mismatched bone marrow transplants. The application employs the CEP(R) X Spectrum Orange(TM)/CEP(R) Y Spectrum Green(TM) DNA Probe Kit from Vysis, Inc. (Downer`s Grove, IL). The procedure is an adjunct to standard karyotyping, or routine chromosome analysis, for which the CytoVision(R) system is the most widely used instrument in the world.

"Our ongoing development and commercialization of clinically relevant, FDA-cleared applications is an important element in the execution of our strategy to maintain our market leadership position in clinical genetics and grow our market share in pathology. This application provides our customers with an important diagnostic tool to better manage leukemias. Our aim is to provide our customers with a broad array of solutions that help to improve significantly the diagnosis, therapy selection and monitoring of a wide variety of cancerous conditions," commented Robin Stracey, Chief Executive Officer of Applied Imaging.

According to the American Cancer Society, in 2004, there will be nearly 1.4 million new cases of cancer diagnosed and more than 500,000 deaths associated with cancer in the U.S. alone. Targeted therapies, such as Gleevec(R) (Novartis Pharmaceuticals) for leukemia, offer new hope for cancer sufferers and may require specific tests to assist in selecting patients for therapy.

About Applied Imaging

Applied Imaging Corp., based in San Jose, California, is the leading supplier of automated imaging systems utilized in genetics and pathology laboratories for the detection and analysis of chromosomes in cancer and prenatal disorders. The Company markets a wide range of imaging systems for fluorescence and brightfield microscopy applications, including the Company`s market-leading Ariol(R) and CytoVision(R) product lines. Applied Imaging has installed over 4,000 systems in over 1000 laboratories in more than 60 countries. The Company is also developing a system for the detection, quantification and characterization of circulating tumor cells from the blood of cancer patients. More information about Applied Imaging can be found at http://www.aicorp.com/.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, regarding, among other matters, the outlook for the Company`s CytoVision(R) system and its applications, our ability to succeed in the clinical genetics and pathology markets, the success of ongoing clinical trials and future development of additional applications targeted at cancerous conditions. Forward looking statements address matters that are subject to a number of risks, uncertainties and other factors, which are detailed in the Company`s periodic filings with the Securities and Exchange Commission. Such risks, uncertainties and other factors include, but are not limited to, those risks and uncertainties listed in the section entitled "Management`s Discussion and Analysis of Financial Condition and Results of Operations -- Factors Affecting Future Results," in Applied Imaging`s annual report on Form 10-K for the year ended December 31, 2003. The forward-looking statements are made as of January 14, 2005, and Applied Imaging is under no obligation to revise or update these statements.

For further information, please contact: Crocker Coulson, President of CCG Investor Relations, [phone], for Applied Imaging Corp.; or Robin Stracey, CEO of Applied Imaging Corp., [phone].

Applied Imaging Corp.



CONTACT: Crocker Coulson, President of CCG Investor Relations,
[phone], for Applied Imaging Corp.; or Robin Stracey, CEO of Applied
Imaging Corp., [phone]



Web site: http://www.ccgir.com/

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http://www.aicorp.com

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Today`s Fair Value 3.30
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Ticker Information
Last Trade 0.99
Change 0.22
Volume 1,138,866
Industry Medical Supplies
Sector Health Care

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