Lab test manufacturer GenMark Diagnostics (NASDAQ: GNMK) announced on Thursday that the U.S. Food and Drug Administration (F.D.A.) had approved its rapid molecular test, ePlex Respiratory Pathogen Panel 2 (RP2 Panel), for emergency use. The diagnostics test can identify and distinguish between over 20 different viruses and bacteria that cause common respiratory infections--including SARS-CoV-2--making it a game changer as parts of the world enter their colder seasons.
"While we can't predict what cold and flu season is going to look like this year, we know that we have to arm healthcare providers with the necessary tools to quickly and accurately diagnose the cause of infections in seriously ill patients, so syndromic testing is going to be critical," said GenMark CEO and President Scott Mendel in a statement.
RP2 Panel provides results within two hours for infections that often have similar symptoms, which can play a crucial role for effective hospital care as the pandemic overlaps with cold and flu season. The test uses a nasopharyngeal swab--which is used to collect samples from the back of the nose and throat--which requires a health care provider to administer.
The test was previously approved for use in European markets, the company said. The F.D.A. has also authorized the GenMark developed test to detect coronavirus infection.
Tests like RP2 Panel have ended the healthcare market at a critical time. The World Health Organization reported a new record one-day increase in global coronavirus cares on Thursday, with a total of 338,779 confirmed cases detected in 24 hours. Cases are now heavily climbing in Europe, with near 97,000 new cases reported on Thursday, the highest the global agency has ever recorded for the region.
Treatment Update
Following the treatment's recent popularity, Regeneron Pharmaceuticals (NASDAQ: REGN) has request an emergency use authorization (E.U.A.) from the F.D.A. for its coronavirus antibody treatment, REGN-COV2.
REGN-COV2 is a combination of two monoclonal antibodies that work to neutralize the coronavirus by aiding an individuals immune system. The antibody cocktail was recently brought into the spotlight because it was part of President Donald Trump's treatment for his coronavirus infection at Walter Reed Medical Center.
The company said that it has currently produced enough REGN-COV2 to treat about 50,000 patients and expects to have enough doses for 300,000 patients developed in the next few months.
The biotech published in statement: "Under our agreement with the U.S. government, if an E.U.A. is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution."
Trump has also confirmed in a multiple Twitter (NYSE: TWTR) videos that antibody treatments developed by Regeneron and Eli Lilly and Company (NYSE: LLY) will be provided to the American public at no cost.