Monday, January 4, 2021

Very Brief Blog: NIH RADx-Funded Novel COVID PCR Device...Being Advertised

 For COVID, emergency use authorizations (EUAs) come in a range of sizes and formats - for lab-developed tests, for test kits to run on big platforms (Thermo Fisher, Roche, Hologic), for compact devices (Cepheid)...and for novel devices.   

I've been uncertain how the timeline for novel devices compares to the other modalities.   I was surprised but happy to see a advertisement for the VISBY device in a new issue of CAP TODAY...suggesting it is well along in the real-world commercialization path.

In September, 360Dx described the device as "Patient-side, Disposable, Molecular PCR Diagnostic Device, a single-use PCR machine the size of a cassette. Founder Adam de la Zerda called the device the 'first and only' single-use PCR instrument up to now and emphasized that everything about the instrument 'has been for single-use.'  "   

The FDA EUA is here.   An October article about its NIH RADx (rapid diagnostics) funding is here.   In September, the company remarked it had filed for CLIA waiver earlier in the year (here).   I believe CLIA-waiver status is still under review.   (In the COVID antigen space, there are EUA and CLIA-waived tests, though).  

The September article also contained the remarks, "[It] doesn't include a service component, which de la Zerda highlighted as a benefit. If the device breaks down, instead of having to wait for a technician to come and fix it, as in the case of a standard PCR machine, the user can just throw it away."


According to an October article, CUE Health in San Diego received $481M in federal funding for a novel compact (but not disposable) diagnostic platform for COVID.


For recent open access articles discussing NIH RADx, here, here.  


I'm not a regulatory expert, but just to mention, there are differences between CLIA-waived for healthcare settings, and FDA permission for home use (like a pregnancy test).  Here, here, here.