The FDA has just approved a new and important Covid-19 test:
“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 Grubaugh.
One of the team’s goals was to eliminate the expensive saliva collection tubes that other companies use to preserve the virus for detection. In a separate study led by Wyllie and the team at the Yale School of Public Health, and recently published on medRxiv, they found that SARS-CoV-2 is stable in saliva for prolonged periods at warm temperatures, and that preservatives or specialized tubes are not necessary for collection of saliva.
Of course this part warmed my heart (doubly):
The related research was funded by the NBA, National Basketball Players Association, and a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University.
The NBA had the wisdom to use its unique “bubble” to run multiple tests on players at once, to see how reliable the less-known tests would be. This WSJ article — “Experts say it could be key to increasing the nation’s testing capacity” — has the entire NBA back story. At an estimated $10 a pop, this could especially be a game-changer for poorer nations. Furthermore, it has the potential to make pooled testing much easier as well.
Here is an excerpt from the research pre-print:
The critical component of our approach is to use saliva instead of respiratory swabs, which enables non-invasive frequent sampling and reduces the need for trained healthcare professionals during collection. Furthermore, we simplified our diagnostic test by (1) not requiring nucleic acid preservatives at sample collection, (2) replacing nucleic acid extraction with a simple proteinase K and heat treatment step, and (3) testing specimens with a dualplex quantitative reverse transcription PCR (RT-qPCR) assay. We validated SalivaDirect with reagents and instruments from multiple vendors to minimize the risk for supply chain issues. Regardless of our tested combination of reagents and instruments from different vendors, we found that SalivaDirect is highly sensitive with a limit of detection of 6-12 SARS-CoV-2 copies/μL.
No need to worry and fuss about RNA extraction now. Here is the best simple explanation of the whole thing.
The researchers are not seeking to commercialize their advance, rather they are making it available for the general benefit of mankind. Here is Nathan Grubaugh on Twitter. Here is Anne Wyllie, also a Kiwi and a Kevin Garnett fan. A further implication of course is that the NBA bubble is not “just sports,” but also has boosted innovation by enabling data collection.
All good news of course, and Fast at that. And this:
“This could be one the first major game changers in fighting the pandemic,” tweeted Andy Slavitt, a former acting administrator of the Centers for Medicare and Medicaid Services in the Obama administration, who expects testing capacity to be expanded significantly. “Rarely am I this enthusiastic… They are turning testing from a bespoke suit to a low-cost commodity.”
And here is coverage from Zach Lowe. I am very pleased with the course of Fast Grants more generally, and you will be hearing more about it in the future.