FDA Grants Marketing Authorization for Healgen Scientific’s Home Flu and COVID-19 Combination Test

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The FDA has granted De Novo marketing authorization for Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test, the first at-home flu and COVID-19 combination test to be available outside of emergency use. According to the company, the test can detect proteins from SARS-CoV-2 and influenza A and B using a nasal swab, delivering results in approximately 15 minutes. Validation of the test was supported by the Independent Test Assessment Program (ITAP), part of National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program.^1,2

“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,” said Michelle Tarver, MD, PhD, acting, Center for Devices and Radiological Health, FDA, in a press release. “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”

According to Healgen, the test, which is authorized for individuals over the age of 14 years, has demonstrated a high level of accuracy. Results have identified 99% of negative cases as well as 92% of positive COVID cases, along with nearly 100% accuracy for negative flu cases. However, the FDA warns that despite its high accuracy level, users should still be on the lookout for potential false positives and seek medical attention if symptoms are persistent.^1,2

“The OTC Healgen Rapid Check COVID-19/Flu A&B Antigen Test provides rapid, accurate and convenient detection of COVID-19, influenza A and influenza B infections. “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,” said Bingliang Fang, CEO, Healgen, in a press release. “Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission.”

In addition to the De Novo authorization, the FDA is preparing criteria called special controls, which define the requirements related to labeling and performance testing. According to the government agency, when this is met, special controls in combination with general controls will provide assurance of safety and effectiveness for tests of this type. Further, the FDA explained that the test will set the stage for future tests in this category to use the 510(k) regulatory pathway, streamlining market entry for similar products.¹

Back in June, the FDA first cleared the Healgen COVID-19/Flu A&B Rapid Antigen test for Emergency Use Authorization by authorized laboratories.³

According to a study conducted by the American Society for Microbiology, the sensitivity of clinician and self-collected rapid testing have yielded similar results, with clinician tests offering 88.2% accuracy and self-collected tests offering 83.9% accuracy. However, results were much less accurate in asymptomatic cases, with 63% reported for clinician tests and 52% for self-administered tests. Symptomatic cases offered higher accuracy, with 90% for clinician tests and 88% for self-administered tests.^4,5

“This De Novo authorization represents a significant milestone for Healgen. With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season,” said Bryan Fang, president, Healgen, in the press release.

References

1. FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities. FDA. October 7, 2024. Accessed October 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use#:~:text=FDA%20News%20Release-,FDA%20Authorizes%20Marketing%20of%20First%20Home%20Flu%20and%20COVID%2D19,Outside%20of%20Emergency%20Use%20Authorities&text=Today%2C%20the%20U.S.%20Food%20and,19%2FFlu%20A%26B%20Antigen%20Test.

2. Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test. Healgen. October 8, 2024. Accessed October 10, 2024. https://www.healgen.com/news_detail_3231.html

3. Now Emergency Use Authorized: Healgen COVID-19/Flu A&B Rapid Antigen Test Cassette (Swab) Test. Healgen. June 13, 2024. Accessed October 10, 2024. https://www.healgen.com/news_detail_1983.html

4. How Accurate Is a Patient’s Home Rapid Test Result? IDSA. March 6, 2024. Accessed October 10, 2024. https://www.idsociety.org/covid-19-real-time-learning-network/diagnostics/how-accurate-is-a-patients-home-rapid-test-result/#/+/0/publishedDate_na_dt/desc/

5. Self-administered versus clinician-performed BinaxNOW COVID rapid test: a comparison of accuracy. ASM Journals. February 13, 2024. Accessed October 10, 2024. https://journals.asm.org/doi/10.1128/spectrum.02525-23