Last we heard, the FDA just needed a little more information for the approval. Where's it at? At what about a chlamydia or gc test?
From a lab sales person, it doesn't matter. Once one company has it, nobody gives a shit. It's the same fucking thing. Why spend the money?
Because you can't SELL it until it's FDA approved. Cytyc has the advantage of haveing sales reps who can sell HPV testing, CT/NG testing, glandular disease detection, and image guided computerized screening. I'm sure Monogen and Shandon will have FDA approved HPV out of their vials before Tripath does.
Tripath reps better hope BD has something up their sleeve for them. Surepath is an OK test, but the offices have to go through to much pain to change over. Add that to the flakey nature of lab reps and that makes for a very unstable situation. Good luck.
What's it been now? Three years since the last denial from the FDA? You know Tripath "voluntarily" pulls their submission when they get the denial from the FDA. You would think with BD's STD business they could get CT/NG approval by now as well. Oh well.
Once and for all get it through your head there will NEVER be FDA approval for HPV. SO all of the people that will not switch for this lame reason will still be the clients you will never get.
The FDA did approve it. They also approved the home self pap test kit. It was a glorious day at the FDA.
All the Cytyc people who post on this board should themselves submit a request for FDA approval for their personalized Colo-Rectal cancer detection test, since they already have their heads up their butts and they know everything!
I had the weirdest experience interviewing with this company....I got the impression they were all looney??
New to the industry-coming from Pharma-Inveiwing with Qiagen to sell their HPV test--they say they have no competitors. How does this test compete in the HPV market? How many different types of test are there (the 2 diff kinds of pap test)? What products all compete in the eyes of an OBGYN for testing for HPV-just trying to understand the market
Where are you interviewing at? Digene/qiagen has virtually all hpv business in my area. thinprep(cytec) is still main player in pap business with surepath(BD/tripath) still holding a small but decent share. don't see much else (except for old farts using conventional slides). last I heard digene has the only fda approved hpv test and both major labs lab corp and quest only offer digene's test. pretty much have the market cornored. biggest problem is insurance coverage (depending on the area) and dumb physicians who won't adopt technology. hope this helps. good luck interviewing.
I see one of your biggest problems as the fact that insurance reimbursement is terrible in most parts of the country yet since you (for now) have the only fda approved method for a test which is now standard of care (on ASCUS cases, not primary screening) the company still charges a premium for supplies. As soon as Third Wave or someone else comes out with another fda approved test, I see a majority of the industry, especially independent path labs moving to the alternative test. Digene has not made many friends by continuing to charge a premium for kits even though everyone's reimbursement has significantly dropped.
Above posters are correct. Seems push is to make HPV test the primary screen, but NO trial data available. Docs unlikely to change how they practice medicine without this. Often need support recommendation from bodies such as AMA, ACOG, ASCCP - and then conversion will still be one doc at a time. LBCs have been available for 12 years and there are still docs doing glass slides! As mentioned, cost is prohibitive to across the board adoption. And when reimbursement falls below lab's cost how long can they support the platform? They are paying to run the test! With competitors like Third Wave and Roche submitting for approval shortly, Digene/Quiagen may not be your best bet.
