I'm getting solid feedback on this from a mate of mine who's a senior analyst in NYC for a major global bank. I have also heard on the grapevine from a guy that knows someone at Sonic CPL in Texas that PapType could be good to go in the new year (just need ISO certification, GMP stock and internal validation, all mentioned in the prospectus). I understand that Gribbles have already got it NATA approved here in Oz last year.
As long as Sonic are named as a particiapting lab in any application to the FDA under an IDE they can sell it and patients can get re-imbursement. According to Digene material the ASP for their test = US$21 and average re-imbursement across the US market = US$49...nice margin for everyone!
Whilst Genera's test provides for more info to the patient(genotypes all 14 high risk types as well as 2 low risk types) I imagine that from a pricing point of view it still would have to sold at a discount to US$21...how big as discount I have no idea.
A discount to Digene and more info to the patient would be attractive to Sonic (and other labs) as their business s purely about providing a test that is accurate and give the necessary info as well as price and volume. If Gribbles have it already NATA approved I imagine that it is accurate as otherwise they wouldn't get NATA status.
I agree with you that it'll be a lot easier for Genera than someone like PLT in getting the labs to adopt their product.
My understanding is that PLT is trying to do 'self sampling' for cervical smears whereby women take the sample themsleves in the privacy of their own home or at the GP's surgery and then it goes off for HPV testing.
In this sense PLT is trying to chip away at Cytyc's market for LBC (their current product is ThinPrep and it has 65% of the Pap smear market in the US...Cytyc is now part of Hologic after being acquired in a US$6.2bn deal last year)...Genera is going after Digene's market (along with a host of others including Roche, Ventana and Thirdwave Technologies).
PLT's Truscreen product is for developing world where path lab infrastructure is not great...different game completely.
If you want to get right up to speed check out these 2 reports I have put up at the following links
