FDA Grants Emergency Authorization to Aptitude’s COVID, Flu Test
The next-gen molecular Metrix was given emergency use authorization for its ability to test for SARS-CoV-2 and influenza A and B viruses.
The FDA granted emergency use authorization (EUA) to the Metrix COVID/Flu multiplex test, according to a news release.1 Cleared for over-the-counter use, this newly authorized advancement in diagnostic technology can be used at home, in point-of-care (POC) settings, or any other environment.
Molecular diagnostics are the gold standard for accuracy in point-of-care testing. | image credit: Yoonnam / stock.adobe.com
“Molecular diagnostics are the gold standard for accuracy, but traditional systems are expensive, slow, and force molecular to be greatly underutilized,” said Scott Ferguson, PhD, CEO of Aptitude, in a release.1 “Metrix changes all that.”
The newly authorized multiplex device has the ability to test for SARS-CoV-2 as well as both influenza type A and B. Patients using the technology will be able to have results within approximately 20 minutes. Metrix and the developers at Aptitude share the goal of making POC testing as accessible as it possibly can.
READ MORE: COVID-19 Had Worst Disease Outcomes Among Respiratory Viruses
“We built Metrix to dramatically expand the reach of molecular diagnostics by breaking cost and accessibility barriers,” said Ferguson. “Our Metrix COVID/Flu test empowers individuals to get their own lab-quality results on the spot in their homes and enables health care providers to upgrade from existing molecular and antigen testing platforms while lowering total cost of care.”
With Aptitude’s dual focus on both patients and providers, it hopes that the Metrix COVID/flu test can alleviate some of the known barriers associated with POC testing. From patient misidentification to the scanning of loose labels,2 the barriers impeding successful POC testing are commonly related to errors made during testing.
Recent trends in the increase of at-home testing have created higher risk of errors. Because POC testing is moving from a health care setting to the home, untrained, non-medical users may not operate tests correctly. Furthermore, individuals conducting an at-home test do not have the expertise of specimen analysis that lab employees may have.3
“The development and production costs of [POC testing] devices can be high, especially when considering the need for miniaturization and the use of specialized materials,” wrote the authors.3 Like many emerging technologies, new POC testing may also have its challenges regarding costs. However, despite high costs and hurdles in adapting at-home tests, Aptitude’s newest product is attempting to push POC testing forward in a way the industry has not seen before.
“COVID-19 and flu are the top respiratory health threats in the United States, driving tens of millions of urgent care visits annually,” said Jackson Gong, PhD, COO of Aptitude. “Health care providers often find traditional molecular testing too cumbersome and cost prohibitive, and instead resort to antigen tests which offer much lower clinical value. What makes Metrix so exciting for urgent care is that it truly solves the cost burden, allowing providers to deliver better medicine and improve the financial viability of their practices, on which over half of Americans depend.”
Metrix’s EUA comes at a time where vaccine access and hesitancy are growing concerns within the US. According to a Global Healthy Living Foundation (GHLF) survey, 54% of participants raised concerns about access to vaccines and 11% said they did not plan to receive a vaccine during the 2024-25 respiratory virus season.4
“These aren’t just data points—these are a wake-up call,” said Seth Ginsberg, President and Co-Founder of GHLF. “The concerns voiced by patients, particularly regarding vaccine access, highlight critical gaps in our health care system.”
While the newly authorized Metrix is not going to keep patients protected against respiratory viruses, it will allow them to be proactive about their health and conduct POC testing in the comforts of their own home. According to Aptitude, Metrix offers providers an upgrade to their POC testing while offering patients an affordable way to stay knowledgeable about their own diagnostics.1
“The Metrix COVID/Flu test is available nationwide through Aptitude and our distribution partners in collaboration with Sekisui Diagnostics,” concluded Gong in the news release.
READ MORE: Vaccine Hesitancy, Access Growing Concerns Among Patients With Chronic Diseases
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