Genmark Diagnostics:Test Kits Designed for SARS-CoV-2

eröffnet am 09.03.20 21:25:36 von
neuester Beitrag 13.11.20 14:14:09 von

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09.03.20 21:25:36
GenMark Diagnostics Announces Global Shipments of ePlex® RUO Test Kits Designed for SARS-CoV-2 Detection…
“In just one month, our team completed the design, manufacture and shipment of initial tests to customers for validation of our assay design using clinical samples. This is a strong demonstration of the GenMark teams’ scientific and operational expertise, the capability of our novel ePlex technology, and our ability to quickly adapt ePlex to meet a specific market need,” said Scott Mendel, Interim Chief Executive Officer. “COVID-19 is a global health emergency and we believe it is important to use our technology and resources to contribute in the fight against this disease. We are pursuing FDA’s EUA regulatory pathway for this test with the goal to provide broad access to an easy to use, sample-to-answer solution for detection of this emerging virus,” concluded Mr. Mendel.

habe hier mal einen hersteller von diagnostik-kits reingestellt. covid-19 auf dem vormarsch, impfstoffe und therapien stehen noch aus, aber die diagnostik funktioniert und wird bereits verwendet. gnmk wollte gerade erst "losrennen" als heute der jähe markteibruch kam. die kits werden wohl noch lange zeit gebraucht, wenn man die epidemiologie bedenkt.

lg, thums
GenMark Diagnostics | 4,910 $
11.03.20 13:49:24
GenMark Diagnostics Announces Submission of Emergency Use Authorization for its ePlex® SARS-CoV-2 Test
CARLSBAD, Calif., March 11, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its ePlex SARS-CoV-2 Test. Upon issuance of an EUA, the ePlex test could be utilized by clinical laboratories for detection of SARS-CoV-2. Initial Research Use Only (RUO) tests were shipped last week to several key customers to validate the assay design using clinical samples.

“Our priority was to help our customers address this global health emergency. We leveraged our adaptable and easy-to-use ePlex platform to quickly design and manufacture a test to accurately detect this highly contagious virus in clinical samples,” said Scott Mendel, Interim Chief Executive Officer. “EUA submission in just over a week from the initial RUO shipments of our ePlex test is a critical step to enable our customers to rapidly detect and possibly prevent the spread of the COVID-19 virus.”…
GenMark Diagnostics | 4,960 €
12.03.20 07:43:13
GenMark Diagnostics | 5,420 $
12.03.20 15:57:23

des einen leid, des anderen freud ;)
ein paar 5,17er abgegriffen im freien fall.
GenMark Diagnostics | 5,570 $
12.03.20 21:42:21
Northwell Labs begins semi-automated testing for COVID-19
Through an emergency use authorization submitted Tuesday night to the US Food & Drug Administration (FDA), the lab now has approval to move immediately from manual testing to the lab’s semi-automated molecular diagnostic system, developed by GenMark Diagnostics, Inc.
“Since we began manual testing Sunday evening, we processed about 133 tests,” said Labs Executive Director Dwayne Breining, MD. “Moving to this semi-automated system will enable us to increase our testing capacity immediately to about 160 a day, and then to several hundred a day later this week."…

ein fda-approval würde die kapazitäten verzig-fachen, da man erst dann auf vollautomatischen betrieb umstellen kann.

GenMark Diagnostics | 6,000 $
20.03.20 09:43:14
FDA Zulassung ist erteilt, der Kurs reagiert sofort...
GenMark Diagnostics | 7,600 €
3 Antworten
20.03.20 15:03:31
Antwort auf Beitrag Nr.: 63.073.930 von bernd1980 am 20.03.20 09:43:14anstiege sind dieserzeit wohl kurzlebig...
GenMark Diagnostics | 6,800 €
2 Antworten
20.03.20 19:53:10
Antwort auf Beitrag Nr.: 63.078.472 von ThumsUp am 20.03.20 15:03:31ja, sieht so aus, leider 😕
GenMark Diagnostics | 5,220 $
1 Antwort
24.03.20 09:39:48
Antwort auf Beitrag Nr.: 63.081.580 von bernd1980 am 20.03.20 19:53:10

die lücke ist zu, die news sind da. könnte von mir aus ab hier steigen.

GenMark Awarded BARDA Grant for the Development of ePlex® RP2 Panel
GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced it has been awarded a grant from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

lg, thums
GenMark Diagnostics | 4,000 €
07.04.20 22:20:39…
First Quarter 2020 Financial Highlights
Total revenue expected to be approximately $38.7 million, representing an increase of approximately 80% over the first quarter of 2019
ePlex® revenue expected to be approximately $34.3 million, an increase of approximately 119% compared to the first quarter of 2019
Average annuity per analyzer of approximately $214,000, up 29% versus the first quarter of 2019
COVID-19 positively impacted first quarter placements and revenue◦
Approximately 80% of gross placements included interest in COVID-19 testing
SARS-CoV-2 consumable revenue accounted for approximately 5% of total ePlex revenue
Gross margin expected to be approximately 40%, compared to 27% in the first quarter of 2019
Gross margin expected to be approximately 40%, compared to 27% in the first quarter of 2019
"Our sample-to-answer test enables healthcare providers to determine if a patient has COVID-19 in under two hours and is a critical diagnostic solution for hospitals.
“Our sales and implementation teams responded to significant demand for ePlex instruments resulting in 109 gross placements in the quarter. Our installed base increased by 54 net placements in the quarter as we opportunistically repositioned 55 ePlex analyzers to provide COVID-19 testing capacity across as many customer sites as possible. Importantly, this aggressive repositioning strategy also allowed us to expand into many new customer sites. We believe these placements will drive enduring revenue streams beyond this pandemic as new customers adopt our Respiratory Pathogen and Blood Culture Identification panels," added Mendel.

die hervorgehobene passage gefällt mir besonders. stehen die geräte erstmal in krankenhäusern rum und sind etabliert, werden sie auch künftig genutzt werden.
GenMark Diagnostics | 4,120 €

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Genmark Diagnostics:Test Kits Designed for SARS-CoV-2