Molecular COVID/Flu Multiplex Test is Granted FDA Emergency Use Authorization

Updated Monday, February 24, 2025, at 11:20AM.

A next-generation molecular COVID/Flu multiplex test (Metrix; Aptitude Medical Systems, Inc) received emergency use authorization from the FDA for detection of SARS-CoV-2, Influenza A virus, and Influenza B virus in 20 minutes. The test is authorized for over-the-counter use and represents a significant advancement in accessible molecular diagnostics.¹

Woman blowing nose | Image Credit: © Pormezz - stock.adobe.com

The 2024-2025 respiratory season is one of the most significant seen in decades, according to the CDC. Flu cases and deaths have been substantial, with a reported 86 pediatric deaths as of February 21, 2025. Although visits to health care providers and hospitalizations have dropped, deaths attributed to influenza have risen and are trending up (3%). This is largely due to the significant drop in vaccinations, where less than 50% of adults in the United States are vaccinated against flu and 23.1% against COVID-19.² The CDC has reported that despite the higher activity, there are signs that cases are beginning to drop.^1,2

COVID-19 is also circulating, although deaths and hospitalization remain low. As of the week ending February 15, 2025, deaths have dropped to 1.1% as well as emergency department visits, which is at about 1%. Test positivity has remained relatively stable at 4.6%.³

"COVID-19 and flu are the top respiratory health threats in the United States, driving tens of millions of urgent care visits annually," Jackson Gong PhD, COO, said in a news release. "Healthcare 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 [molecular COVID/Flu multiplex test] 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.”⁴

The molecular COVID/Flu multiplex test simultaneously detects and differentiates SARS-CoV-2, Influenza A virus, and Influenza B virus, with test results in 20 minutes. The test can be used at home and in CLIA-waived point-of-care settings and offers patients a convenient, cost-effective, and timely test to identify flu or COVID-19 infection. ⁴

"Molecular diagnostics are the gold standard for accuracy, but traditional systems are expensive, slow, and force molecular to be greatly underutilized. [The molecular COVID/Flu multiplex test] changes all that," said Scott Ferguson, PhD, CEO of Aptitude, in the news release. "We built [molecular COVID/Flu multiplex test] to dramatically expand the reach of molecular diagnostics by breaking cost and accessibility barriers. Our [molecular COVID/Flu multiplex test] COVID/Flu test empowers individuals to get their own lab-quality results on the spot in their homes and enables healthcare providers to upgrade from existing molecular and antigen testing platforms while lowering total cost of care."⁴

REFERENCES

1. Weekly US influenza surveillance report: Key updates for week 7, ending February 15, 2025. CDC. February 21, 2025. Accessed February 24, 2025. https://www.cdc.gov/fluview/surveillance/2025-week-07.html

2. Flu activity 'elevated' in US but showing signs of abating, CDC data shows. ABC News. February 21, 2025. Accessed February 24, 2025. https://abcnews.go.com/Health/flu-activity-elevated-us-showing-signs-abating-cdc/story?id=119037774

3. COVID data tracker. CDC. February 21, 2025. Accessed February 24, 2025. https://covid.cdc.gov/covid-data-tracker/#datatracker-home

4. Aptitude receives fda authorization for Metrix® COVID/Flu multiplex molecular test for point-of-care and over-the-counter use. PR Newswire. February 24, 2025. Accessed February 24, 2025. https://www.prnewswire.com/news-releases/aptitude-receives-fda-authorization-for-metrix-covidflu-multiplex-molecular-test-for-point-of-care-and-over-the-counter-use-302382621.html