www.fdanews.com/articles/208552-bforcures-point-of-care-pcr-test-gains-ce-ivd-mark
BforCure’s Point-of-Care PCR Test Gains CE-IVD Mark
July 12, 2022
Montreuil, France-based BforCure has received a CE-IVD mark for its Bfast polymerase chain reaction (PCR) test for detecting the SARS-CoV-2 virus from nasopharyngeal samples.
The rapid test, which runs on the company’s Chronos Dx PCR platform, delivers results in 15 minutes at the point-of-care. It includes all the material needed to perform nasopharyngeal sampling and doesn’t require complicated technical handling, the company said.
The test includes freeze-dried reagents that allow the kits to be stored at room temperature.
BforCure calls the rapid, point-of-care test “a major turning point in the field of proximity biological testing.”