NBA and Yale Co-Sponsored Coronavirus Test Scores FDA Authorization
The U.S. Food and Drug Administration (FDA) announced it has issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test.
The SalivaDirect test uses a new method of processing saliva samples when testing for COVID-19 infection. SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing, stated Yale researchers on August 15, 2020.
Moreover, this innovative test was co-sponsored and used by the National Basketball Association (NBA) to reopen the 2020 basketball season in Orlando, Florida. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game-changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D., in a press statement published on August 15, 2020.
SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.
“This is a huge step forward to make testing more accessible,” stated Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation.
Being able to perform a coronavirus test without these kits enhances the capacity for increased testing while reducing the strain on available resources.
Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.
This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.
FDA Commissioner Stephen M. Hahn, M.D. added: “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America.”
“The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.
Furthermore, a non-peer-reviewed study published on August 4, 2020, found this diagnostic test did not require nucleic acid preservatives at sample collection, replaced nucleic acid extraction with a simple proteinase K and heat treatment step, and the testing specimens were with a dualplex quantitative reverse transcription PCR (RT-qPCR) assay.
Additionally, the Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to explore how to implement the test for a broader audience. The laboratory already analyzes patient samples for an RNA signature unique to that of SARS-CoV-2, the virus that causes COVID-19 disease.
“We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically, and with greater accessibility while maintaining acceptable test accuracy,” said Charles Lee, the laboratory’s director.
“This method is an important next step toward this goal.”
The SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance study was funded by a clinical research agreement with the NBA and the National Basketball Players Association, the Huffman Family Donor Advised Fund, Fast Grant funding support from the Emergent Ventures at the Mercatus Center, George Mason University, the Yale Institute for Global Health, and the Beatrice Kleinberg Neuwirth Fund.
The NBA and the NBA players' association do not intend to take royalties from any use of the testing method, sources told ESPN. The NBA and union contributed more than $500,000 combined to fund this Yale research.
This is the 5th test that the FDA has authorized in 2020 that uses saliva as a sample for testing for coronavirus infection.
The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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- Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization
- FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect
- SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance
- Saliva-based coronavirus test funded by NBA, NBPA gets emergency authorization from FDA