RE: Seat of pants CNBC breaking news!!!9 May 2020 16:55
Looking at the FDA approval for Quidel it’s not dependent on % but on the control measures. I have more to read but for now it looks like the EUA was against controls. This is, however, only a summary...
“To use your product, the specimen is first placed in the Reagent Tube, during which time virus particles present in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the sample well of the lateral flow Test Cassette. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If SARS-CoV or SARS-CoV-2 viral antigen is present, they will be trapped in a specific location. Test results of the lateral flow Test Cassettes are read using the Sofia 2 Instrument at 15 minutes, or other authorized instrument. The Sofia 2 SARS Antigen FIA test includes the following materials or other authorized materials: Individually Packaged Test Cassettes, monoclonal anti-SARS antibodies Reagent Tubes, Lyophilize d buffer with detergents and reducing agents, Reagent solution, sterile nasal swabs, 120 µL Fixed Volume Pipettes, SARS Positive Control Swab, and Negative Control Swab.
Your product requires the following control materials, or other authorized control materials, that are processed in the same way as the specimens and are run as outlined in the Instructions for Use:
• SARS Positive Control Swab - swab is coated with non-infectious recombinant SARA antigens. The positive control is used to monitor for failures of test cassette reagents and reaction conditions.
• Negative Control Swab - swab is coated with heat-inactivated, non-infectious Streptococcus C antigen......etc”
Here’s the reference
https://www.fda.gov/media/137886/download
Ps someone mentioned market size and there being enough room for all players. Sure but don’t underestimate the power of first mover advantage. It usually sets the paradigm and lands the biggest contracts. In the case of covid 19, companies will run with whoever is first. Coming second is not the end but being first and accurate is a big deal and avacta will be well aware of that.
Trek