Innovation Pharmaceuticals Inc (IPIX)

[Barron4664]

A question for the experts on the board. Every aspect of the pandemic uses the rt-pcr test. The definition of a case, the vaccine clinical trial protocols. Now the pcr tests are being used to sequence the variants. And yet every diagnostic manufacturer of these tests are operating under a blanket EUA for which the FDA states the following:

“The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).”

I haven’t been able to find any diagnostic clinical studies that would actually validate the pcr test against a gold standard such as isolating and culturing the virus. Surely one of these testing manufacturers would want to have there test kits approved by FDA? Does anyone know of any diagnostic clinical trials that would allow the FDA to change its wording from may be effective to is effective? Does anyone know what IPIX trial protocols are using to determine efficacy with regard to diagnostic testing? How many cycles used ect?