RE: FDA CDC4 Feb 2020 20:18
Must be NCYT, because CEO states:..........
Graham Mullis, CEO of the Paris-based company, told BioWorld. By validating it with the specific sequence of the genome found in the new strain of the virus, the test delivers high levels of assay performance, particularly specificity – an advantage over tests that may react to related species, he said.
The Novacyt test is designed to run on multiple molecular testing platforms, including Primerdesign’s Genesig q16 and 132 instrument, making it suitable for large and small laboratories. It is also stable at ambient temperatures, removing the need for cold chain shipping, which could reduce transportation costs and loss of product.
Novacyt is currently making the test available to laboratories as a research use-only assay throughout its sales channels, and has seen strong, early demand from more than 10 countries. As for broader availability, the company is still determining the best route forward.
“In the event a manufacturer pursued full regulatory approval for clinical use, it could take six months or more with regulators such as the FDA,” he said. “There is an emergency use process with most regulators, and this might reduce the time for a limited approval within weeks, depending upon the criteria the regulators require.
https://www.bioworld.com/articles/432812-novacyt-launches-test-for-new-coronavirus