FDA Authorizes First Influenza, COVID-19 Diagnostic Test

December 08, 2020 - FDA recently authorized the first at-home influenza and COVID-19 diagnostic test intended for patients who are suspected of respiratory viral infection consistent with the coronavirus. 

The test, Quest Diagnostics RC COVID-19 + Flu RT-PCR Test, is authorized for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 Flu when home collection is approved by an individual’s healthcare provider.

This is the second FDA authorization for an at-home COVID-19 diagnostics test for self-testing. The first authorization was in mid-November to Lucira Health for its COVID-19 All-In-One Test Kit.

The test was authorized for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. Additionally, it is authorized for use in point-of-care settings for all ages, but for prescription use only.

“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. 

“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment,” Hahn continued. 

The US had some of the lowest flu vaccination rates last year, which could be a serious issue for COVID-19 vaccine rollout. 

A mid-November Kaiser Family Foundation (KFF) report indicated that states must address variations in flu vaccination uptake to ensure a successful COVID-19 vaccine distribution.

Data from the CDC’s 2019 to 2020 Influenza Season Vaccination Coverage Dashboard showed that 52 percent of the US population six months and older received the seasonal flu vaccine last season.

Specifically, rates for flu vaccination were the highest in the Northeast (57 percent), followed by the Midwest (54 percent), the South (52 percent), and the West (51 percent).

Notably, the national flu vaccination percentage was well below the Healthy People 2030 target of 70 percent for all racial groups.

Additionally, Black and Hispanic people were even less likely to receive the flu vaccination compared to White people, and just 40 percent of non-ederly adults without underlying conditions received the flu vaccine in the 2019 to 2020 season.

The findings could have major implications on COVID-19 vaccine distribution, researchers emphasized.

Although Quest Diagnostics and Lucira Health received the first FDA authorizations for their at-home testing kits, other top pharmaceutical companies announced collaborations to advance their individual at-home COVID-19 tests throughout the pandemic.

At the beginning of May, Alveo Technologies announced a collaboration with Janssen Pharmaceuticals to advance the company’s at-home testing platform that detects viral infections, including COVID-19.

The be. well testing system includes analyzers, nasal swabs, and cartridges for the detection of viral infection diseases, including Respiratory Syncytial Virus (RSV) and SARS-CoV-2. The platform can be adapted to detect a wide range of diseases that threaten public health, Alveo noted in the May announcement.

Then at the end of September, Gauss and Cellex announced an exclusive partnership to launch the first-ever rapid, at-home COVID-19 antigen test.

Once approved by FDA, the test would be the first to allow individuals to test themselves for active COVID-19 infection and receive rapid results while at home.