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.
Read More »Roche to acquire GenMark Diagnostics
March 16, 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.
Read More »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.
Read More »GenMark ePlex Respiratory Pathogen Panel 2 receives EUA
Oct. 9, 2020—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2.
Read More »GenMark launches ePlex RP2 Panel
September 2020—GenMark Diagnostics announced that its ePlex Respiratory Pathogen 2 Panel is available for U.S. commercial distribution and clinical use.
Read More »GenMark launches ePlex Respiratory Pathogen Panel 2
July 21, 2020—GenMark Diagnostics announced that its ePlex Respiratory Pathogen 2 Panel is available for U.S. commercial distribution and clinical use.
Read More »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.
Read More »FDA clears GenMark Dx BCID panel
June 2019—GenMark Diagnostics received FDA 510(k) clearance for its ePlex Blood Culture Identification Gram-Negative Panel.
Read More »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.
Read More »CE mark for molecular Dx system, 8/16
August 2016—GenMark Diagnostics received the CE mark for its ePlex Instrument System and ePlex Respiratory Pathogen (RP) Panel. The panel detects 20 viral and three bacterial targets in nasopharyngeal specimens.
Read More »