The FDA points emergency clearance for the GenMark take a look at, which appears for the flu, coronavirus, and different viruses
A health worker takes a nasal swab sample from a student to test for COVID-19 at the Brooklyn Health Medical Alliance pop-up testing site as infection rates rise in New York City on October 8, 2020.
Angela Weiss | AFP | Getty Images
California-based laboratory test maker GenMark Diagnostics announced Thursday that the Food and Drug Administration has granted emergency approval for its rapid molecular test, which can distinguish between more than 20 different viruses and bacteria, including the coronavirus.
Flu and Covid-19 patients typically develop similar symptoms early in the virus, which could make it difficult for doctors and nurses to diagnose patients and find the best treatment this flu season. Tests like GenMarks, which can scan for flu, coronavirus and other pathogens at the same time, could be crucial in helping hospitals effectively treat Covid-19 and influenza patients this winter, public health professionals say.
Genmark's shares rose approximately 15% after the close of trading, but reduced their profits and rose more than 4% in after-hours trading.
"While we cannot predict what the cold and flu season will look like this year, we know we need to equip healthcare providers with the tools they need to quickly and accurately diagnose the cause of infections in critically ill patients, which will be critical" said Scott Mendel, CEO of GenMark, in a statement.
Known as the ePlex Respiratory Pathogen Panel 2, the test uses a nasopharyngeal swab to collect samples and, according to the company, provides results in less than two hours. The test was funded in part by the Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services. Through the contract, BARDA awarded the company up to $ 749,000 to develop the test, the company said in March.
The test was approved for use in Europe about a month ago, the company said. The FDA previously approved a GenMark diagnostic test for the coronavirus.