Thermo Fisher Scientific to Expand At-Home COVID-19 Testing

Thermo Fisher Scientific recently announced it has received an expansion of its emergency use authorization for a COVID-19 testing kit to include an additional sample collection method provided by digital health company, Everlywell. 

The company’s TaqPath Combo Kit is authorized for use with Everlywell’s COVID-19 Test Home Collection Kit, which allows individuals to self-collect nasal swab specimens when authorized by a healthcare professional.

The authorization is based on results from the results of an individual’s COVID-19 questionnaire. 

CLIA-certified laboratories running Thermo Fisher’s TaqMan SARS-CoV-2 RNase P Assay Kit can process these samples and the results can be viewed through the Everlywell online platform, the announcement said.

The at-home testing kit is anticipated to increase access to highly accurate PCR-based testing and help keep workplaces, schools, and organizations safe over the coming months.

"As part of our commitment to keep our workplaces safe and healthy, Thermo Fisher launched its own pilot program to provide at-home collection kits and online access to test results for more than 10,000 colleagues across the country," Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific, said in the announcement. 

"Now, leveraging Everlywell's capabilities, we can expand our own use and offer other organizations the confidence to move forward with return-to-workplace strategies that reduce the risk of spreading the virus."

Affordable access to real-time, at-home results can help transform the way healthcare providers identify and manage COVID-19, as well as support better-informed decisions for patients and their families. 

Back in May, Alveo Technologies collaborated with Janssen Pharmaceuticals, part of Johnson & Johnson, to advance the company’s at-home COVID-19 testing platform. 

The be.well testing system includes analyzers, nasal swabs, and cartridges for the detection of viral infection diseases, including SARS-CoV-2. Test results are available to patients in 30 minutes.

Alveo also stated that it will use a phased approach to gain an emergency use authorization for SARS-CoV-2 assays, followed by a test for home use.

Currently, Alveo’s be.well app is under development to be the first cloud-enabled, secure, HIPAA compliant application program to be paired with an at-home test.

Last month, Gauss and Cellex also announced an exclusive partnership to launch the first-ever rapid, at-home COVID-19 antigen test.

The test would be the first to allow individuals to test themselves for active COVID-19 infection and receive rapid results once approved by FDA.

Cellex received emergency use authorization from the FDA for its rapid COVID-19 antibody test back in April and is now in advanced clinical trials. The trials are evaluating the rapid antigen test that targets the nucleocapsid protein on the SARS-CoV-2 virus.

In early trials, the antigen test has shown 90 percent sensitivity and 100 percent specificity.

The companies noted that when paired with Gauss’ artificial intelligence-powered application, the test can be expanded to assist in the rapid diagnosis of COVID-19 infections in both at-home and point-of-care settings.

Users will receive step-by-step instructions to correctly perform the rapid test. Individuals can then scan their rapid test with their smartphone within 15 minutes after testing.

FDA has yet to approve an at-home COVID-19 test, leaving the market open for companies to innovate.

Notably, Thermo Fisher has continuously put forth efforts to expand COVID-19 testing during the pandemic.

Just last week, the company introduced two COVID-19 antibody tests, OmniPATH COVID-19 Total Antibody ElISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test.

The company created the OmniPATH test in conjunction with the Mayo Clinic and WuXi Diagnostics. FDA has granted emergency use authorization. 

The EliA test is currently commercially available following FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised),” but an emergency use authorization is currently under review by the FDA.

Both of these new antibody tests are designed to allows laboratories to run the tests at an efficient speed and throughput while using automated instruments already in place, Thermo Fisher said in the announcement. 

Overall, this move minimizes initial costs and reduces the time needed to begin testing.