By Mike Freeman
The San Diego Union-Tribune
With flu season approaching, GenMark Diagnostics of Carlsbad, Calif., has received regulatory approval for a combination lab test that can detect COVID-19 along with 20 other common respiratory ailments from a single test.
The multiplex — or syndromic — panel ferrets out infections with similar symptoms such as fever, cough and body aches. It delivers results within two hours and targets patients who come into hospitals with symptoms of a respiratory ailment, which on the surface are likely to be similar to COVID, influenza strains, bronchitis and common colds circulating this fall and winter.
“We are looking at this as a dual-threat season with circulating influenza, SARS coronavirus and then all the other respiratory viruses,” said GenMark Diagnostic Senior Vice President, Scott O’Brien. “Therefore, it’s important to test those patients to determine the course of therapy. The value of the results has escalated in a season like this.”
Last week, GenMark received Emergency Use Authorization from the U.S. Food and Drug Administration for its Respiratory Pathogen Panel 2 test. It runs on GenMark’s proprietary ePlex analyzers, which are deployed in 720 mostly large and mid-size hospitals worldwide, with a majority in the U.S.
In addition to COVID and five flu strains, the test also picks up Adenovirus, various human rhinoviruses, parainfluenza, Respiratory Syncytial Virus and certain bacterial infections.
“If they don’t know what they have, it impacts how they re-enter with the public, how they go back to work,” said O’Brien. “It impacts if they isolate themselves longer. It impacts the need for re-testing and using (hospital) resources to do that.”
Syndromic testing has been around for about five years or so. In March, GenMark received FDA Emergency Use Approval for a stand-alone COVID-19 test. Now it has combined that into a more wide-ranging test for multiple respiratory ailments.
The PCR test, which hunts down genetic material from the viruses, is considered more accurate than antigen tests, which are inexpensive and provide quick, repeatable results in as little as 15 minutes.
Antigen tests have become a more widely available tool for screening people without symptoms for COVID, particularly those working in nursing homes or other high-risk settings. College and professional athletes also use rapid antigen tests to COVID screening before practice and games.
Syndromic panel tests, on the other hand, are not as widely available, said O’Brien. That means doctors must order a series of standalone tests for COVID or the flu or other ailments to make a diagnosis for people with symptoms.
“People say, Oh, there is tons of testing available,” said O’Brien. “Well, there is for certain kinds of tests. Send-out tests, there are tons of those. Antigen tests, there are lot of those. But quick, highly sensitive test for hospitals, that is still an area that is underserved.”
GenMark, BioFire and Cepheid are the most active in the market now, with Luminex also working on a panel test.
Demand for GenMark’s test so far has been strong, said O’Brien. The company manufactures the panels at facilities in Carlsbad, where it employs about 600 workers.
“COVID-19 is placing a spotlight on the importance of fast, comprehensive molecular testing,” said Scott Mendel, chief executive of GenMark, in a statement. “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.”
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