hpv competitors, page-15

TTH

Thanks for the welcome

You could say that I have some expertise in diagnostics and devices and I have made more money than lost investing PA.

It appears to me that Gribbles has undertaken a validation of the Genera test internally, this is best practice for a path lab under NATA accredited guidelines. The test as its stands today in the US would be called a 'home brew.' The FDA is going to review its position on home brew tests in the next 2-3 years so timing for Genera appears to be great.

Clinical studies are a different thing all together. It appears that Genera is quite sensibly taking the product into the US market via Sonic through the loophole that exists with the FDA under Investigational Device Exemptions (IDEs). Essentially if a lab is named in a company's IDE application with the FDA they can sell the test and most importantly get reimbersment from the insurers. Effectively they will be generating revenue while generating clinical data for FDA approval. The clinical data then goes into what's called a PMA (Premarket Approval) to be lodged with the FDA. It is this clinical data package that the FDA looks at to decide whether or not to approve the test. Once approved, the company is then free to sell to the wider market. Note that prior to FDA PMA approval Genera can only sell to those high complexity path labs (as defined under CLIA) that are named in its IDE.

These guys appear to me to be dealing 'direct' (not via a 3rd party distributor) which intuitively means that margins should be higher (assuming that Genera mgmt are good negotiators). Also due to the sheer size of Sonic, revenue generated under IDE sales may just be enough to put the company into profitabilty even prior to getting an FDA approved product on the market. Very smart re managing dilution! Besides Sonic their only better partners in the world would have been Quest or Labcorp.

This area of HPV testing is going to be huge as over the next 5 to 10 years it moves to pretty much replace the Pap.

Caveat emptor

cheers

Deca