1/ Important update: This evening, our lab partner notified us that the FDA updated their FAQ about COVID-19 testing. The update clarifies that at-home sample collection is not covered under the EUA (emergency use authorization)
fda.gov/medical-device…
fda.gov/medical-device…
2/ We (@CarbonHealth) are discontinuing the distribution of at-home sample collection kits and contacting the first group of patients to schedule expedited testing in our clinics. FDA supports at-home collection but needs more data to validate its accuracy.
3/ We're doing 50-100 COVID-19 tests in our clinics every day. We will continue to look for additional ways to expand testing capacity. We still believe in the value of at-home sample collection so we will work with our lab partners to accelerate data collection.
4/ We will continue to be transparent about how things progress.
