http://www.medicalnewstoday.com/articles/76586.php I can't tell if this is on the market yet or not from the Seegene PR...anyone comment on the competitive threat of genotyping tests? TWTI expects to file(510K) on a 16/18 genotyping test next quarter.
These are potentially complimentary to Digene and Roche(approval expected soon) broad spectrum tests.If ASCCP guides for HPV with PAP and a woman's QGEN/DIGE/Roche hpv results are positive,you'd think it w/b advisable to test specifically for 16/18 for risk stratification. Thoughts?
I wonder if QGEN management is aware of TWTI...if they are, and they did (do) the DIGE deal, then either they are not too swift, or TWTI is not an issue at present....if they are not (aware) , then they haven't done their DD before the DIGE deal... From all that I've read and heard, QGEN management seems quite capable (to say the least), so...
They are clearly aware of twti because QGEN was asked(on CC when digene bid announced) about DIGE's patent suit against them and QGEN said we'll indicate our intentions about that suit after we close the merger.TWTI has a counter claim against Digene under federal anti-competitive statutes and the Court here is on the verge of issuing a Markman Decision on Digene's infringement claims w/i the coming weeks.
More generally,TWTI's test(510K to be filed before year end)genotypes 16 and 18.It is in the midst of final clinical testing which ends this Quarter-so it's at least 12-18 months from market.My point is...won't the ability to ID 16 and 18 in women that test positively on the Digene test allow physicians to closely monitor the higher risk women and,therfore,be very complimentary to the broad spectrum test?
Might not twti be a solid acquisition candidate IF clinical results are good,they file their 510K by year end and are successful in the Digene litigation? I know, a lot of ifs,but was interested in any comments from the perspective of 16-18 genotyping competition/complimentary testing.