Predictive Technology Group Inc (PRED)

[zhangguangming]

https://www.360dx.com/immunoassays/faced-confusion-questionable-claims-fda-addresses-coronavirus-serology-testing#.Xo9keWNKiM8

This should help clear the air on the usage of the words "approved" and "authorized"

"Since the FDA began allowing serology-based SARS-CoV-2 tests to be marketed under policies C and D, some firms have launched their products with dubious claims about their regulatory status, which has caught the FDA's attention. The agency is trying to make it clear that firms that have gone through Policy D are not EUA authorized, and on Tuesday FDA Commissioner Steven Hahn issued a statement stating, "Some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.""

So we can clearly see that PRED is NOT FDA "approved" further it is NOT FDA "authorized". Any such claims are false and the FDA will take action

We can all agree that PRED and many others are "POLICY D", and only CELLEX (at this point) is "EUA" aka "POLICY C"

Also interesting :

""It was not our intention to limit the use of rapid serology tests that are otherwise designed to be used in a point-of-care setting. However because of the limits that we have in law, it is the opinion of [the Centers for Medicare and Medicaid Services] that these can be performed in high-complexity labs," Stenzel said. He added that developers can choose to come through a full EUA authorization process so that a test can be deemed point-of-care and be allowed to be used in waived settings."

Was PRED planning on selling to point of care ? Because according to that paragraph they can only sell to labs unless they get the EUA.

"Stenzel followed up to say that the agency may not yet have made clear that point-of-care tests marketed under Policy D are considered high-complexity tests, as there are two related posts on the FAQ page. "We'll try to resolve the confusion on the website," he said."

According to that they admit it was an easy mistake to make. Maybe PRED thought they could sell to point of care as well. No harm no foul.