Yale saliva test for COVID-19 receives FDA’s emergency approval after a trial on NBA players

The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.

 Yale press news release.

The method requires no extraction of nucleic acid and uses several readily available reagents.

“This test is also unique because it does not require a separate nucleic acid extraction step,” the FDA said. “This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources.”

“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Nathan Grubaugh assistant professor at Yale and part of the team of researchers who led the program.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

Photo by Medakit Ltd on Unsplash

Image by Shafin Al Asad Protic from Pixabay

FDA Warns on Dangerous Hand Sanitizers Consumers Should Not Use

Trump Administration Collaborates with Moderna to Produce 100 Million Doses of COVID-19 Investigational Vaccine

Amazon Gets Hit With a Huge Court Loss That Could Open the Door for Other Lawsuits

Comments


CWEB.com is not registered as an investment adviser with the U.S. Securities and Exchange Commission. Rather, CWEB.com relies upon the “publisher’s exclusion” from the definition of investment adviser as provided under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws.

Full Disclaimer

%d bloggers like this: