Re:We’re working on 1M Covid-19 testing capacity per day
by billiontoone on Tuesday April 07, 2020 @07:09PM
(#22808448)
CEO of BillionToOne here.
We have already generated and put into our scientific manuscript the data that FDA requires for EUA. As a high-complexity CLIA-licensed clinical laboratory, we don't see significant risk in getting the authorization in 2 weeks. However, we need to start working with clinical laboratories across the country today if this is going to scale to hundreds of thousands of tests as soon as we get the EUA. Also, international laboratories don't need EUA and can start using the test immediately. We did not think it would be responsible to hold off on making the technology public when every day is so critical in our response to the current pandemic.
We have already generated and put into our scientific manuscript the data that FDA requires for EUA. As a high-complexity CLIA-licensed clinical laboratory, we don't see significant risk in getting the authorization in 2 weeks. However, we need to start working with clinical laboratories across the country today if this is going to scale to hundreds of thousands of tests as soon as we get the EUA. Also, international laboratories don't need EUA and can start using the test immediately. We did not think it would be responsible to hold off on making the technology public when every day is so critical in our response to the current pandemic.