FDA Grants Marketing Authorization for Rapid COVID-19/Influenza Antigen Test

The FDA granted marketing authorization for the OTC Healgen Rapid Check COVID-19/Flu A&B Antigen Test, which can be used by individuals who have respiratory symptoms. The test is delivered in a nasal swab and results can be ready in approximately 15 minutes, detecting proteins both from SARS-CoV-2 and influenza A and B.¹

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“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” Michelle Tarver, MD, PhD, acting director of the Center for Devices and Radiological Health at the FDA, said in a news release.¹

In a recent survey, investigators found that few adults in the US intend to get vaccinated against respiratory diseases for the 2024-2025 season. However, 75% of adults said they trusted their physicians, nurses, and pharmacists either a great deal or a lot and cited concerns of adverse events and a general distrust of vaccines to be the reasons for not wanting a vaccination. Getting vaccinated is important to prevent the spread of respiratory diseases; however, this new authorization could play an important role in helping patients identify when they are infected and reduce the spread.²

According to the FDA, the data showed that the test correctly identified 99% of negative tests and 92% of positive COVID-19 samples, 99.9% of negative flu samples, and 92.5% and 90.5% of positive influenza A and influenza B samples, respectively. The test was validated from data gathered through the Independent Test Assessment Program in collaboration with the FDA.¹

This is the first OTC test to detect influenza to be granted a marketing authorization. There are other OTC flu and COVID-19 tests that have been granted emergency use authorization.¹

The test is authorized for individuals 14 years and older who can take their own sample or for those 2 years and older with a sample taken and tested by an adult. The FDA stats that there is a risk of false negative test results with the test, and individuals who do test negative but continue to experience symptoms—including fever, cough, and/or shortness of breath—may still have COVID-19, flu, or another respiratory infection. The agency suggests following up with their health care provider. Further, for those who test positive, individuals should implement the appropriate precautions to reduce the spread of the virus and follow up with their health care provider.¹

"Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home," Bingliang Fang, MD, PhD, CEO of Healgen, said in a news release. "Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission."³

REFERENCES

1. FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities. News release. FDA. October 7, 2024. Accessed October 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use

2. Gallagher A. SURVEY: Few Adults Plan to Get Respiratory Vaccinations for 2024-2025 Season. Pharmacy Times. October 1, 2024. Accessed October 9, 2024. https://www.pharmacytimes.com/view/survey-few-adults-plan-to-get-respiratory-vaccinations-for-2024-2025-season

3. Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test. News release. Healgen. October 8, 2024. Accessed October 9, 2024. https://www.prnewswire.com/news-releases/healgen-scientific-receives-fda-de-novo-marketing-authorization-for-at-home-covid-19-and-influenza-test-302269767.html