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Tag Archives: GenMark Diagnostics

Roche to acquire GenMark Diagnostics

June 2021—Roche and GenMark Diagnostics have entered into a definitive merger agreement for Roche to acquire GenMark for about $1.8 billion on a fully diluted basis. GenMark’s syndromic panel testing portfolio will complement Roche’s molecular diagnostics portfolio, and Roche’s global network will enable expanded reach for GenMark’s products.

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GenMark ePlex RP2 panel receives EUA

January 2021—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2. The test provides results in less than two hours for more than 20 viruses and bacteria that cause respiratory infections, including COVID-19, flu, bronchitis, and the common cold.

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GenMark SARS-CoV-2 test receives EUA

March 20, 2020—The FDA has issued an emergency use authorization for GenMark Diagnostics’ ePlex SARS-CoV-2 Test. The test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 and is for use on the company’s ePlex system, which provides results in less than two hours and can process up to 96 tests per eight-hour shift.

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FDA clears two ePlex blood culture identification panels

Dec. 28, 2018—GenMark Diagnostics has received FDA 510(k) market clearance for its ePlex Blood Culture Identification Fungal Pathogen Panel. This panel, together with the ePlex Blood Culture Identification Gram-Positive Panel, which received FDA clearance Dec. 20, and Gram-Negative Panel were developed for the diagnosis and disease management of bloodstream infections that can lead to sepsis.

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