Made nice profits in DIGE, and I figured I'd move some of the "House"'s $$$ here. My friend worked for Digene and is now on board at QGEN, and he says the transition is going smoothly so far. Perfect niche play imo, $25 looks easy here by springtime...
i failed to notice the huge volume on dax trading friday, over 3 million ... good volume there today...doubt it's just from the JV announcement...back in accumulation mode...have to go back a long way to see a 5% gain intraday on qgen...
the simple answer is that in their original form ASRs were meant to be simply reagents, building blocks, provided to labs to develop and validate their own in-house tests
many companies have tried to backdoor FDA approval (see roche for their cyp/genetic test, hpv etc) by calling something an asr when really it's a full kit
as i read it among other things the fda is saying asrs can be provided to labs but yuo can't tell them how or what to use it for...the spirit of an asr is that the labs develop the test, not the company...that's why this has been so controversial and gone through many drafts
gutman et al. are clamping down on products that ought to be 510k or pma approved but are sneaking through being called asrs
Incas: From the FDA link you provided I read the following:
>>In addition, FDA has clarified that where manufacturers provide laboratories with information describing the use of their product in a specific test, the manufacturer's product would fall outside the definition of an ASR.<<
What does that mean? Why would "describing the use of their product" cause the product to "fall outside the definition of an ASR"?
Your insight would be most appreciated. Thanks.
A three year trial BEFORE approval doesn't seem unreasonable ...always trying to sneak in the back door.
GPRO seems like it will eventually be a formidable competitor; hopefully still a few years off.
Wish we could get that Chlamydia (out of TP) approval. Annual testing on the under 25 crowd is a pretty big volume in our practice.
i think they will definitely be paying attention to clinical sensitivity...the stakes are very high as they well know given the huge impact it can have in such a large screened population with relatively low disease prevalence...
one interesting question i have also is how have twti and gpro determined their cutoff points for disease? it took digene multiple preliminary large trials to establish the roc curves to determine the best cutoff
i wouldn't think it would be kosher to do a post hoc analysis on an fda clinical pivotal trial and say, ok, based on this trial, retrospectively, we'll put the cutoff....here!
would seem to me that one would have to specify cutoff in advance, otherwise it's just data-fitting
couple of other points regarding the competion...you have the pma for the test, you have a pmas for the automated version, and you have the pmas for approval in lbp media, read TP...
have to mull over just exactly why the fda traded sequencing for longer trials...thoughts?
Maybe the FDA will really pay attention to "clinical sensitivity" and demand the same kind of lengthy, costly trials that HCII has been through.
Seems like were are in good shape.
Like you say, its actually nice to be invested in a great company, and not just a great test..
if you check the rest of the transcript there's some color in the q&a on hpv as well...sounds like they (and twti mentioned this on their last call) are going to have genotype all their samples but in return may not have to follow patients for a full three years in the pre-market trials...but realistically from enrollment to study end to submission to approval we're talking probably 3 years at least...however they will have a CE marked product in EU next year...one other point that Schatz made in the presentation regarding Roche and their CE marked product was that it was not presenting much in the way of competition
a gpro offering on tigris could be competitive...we'll see, early days yet
one thing is clear, for both twti and gpro, they are spending a ton of money on this so it better work <gg> and gpro is going to have to also spend a lot bulking up their european sales force...twti would almost have to partner or be bought imho...as we know from the digene experience, the product is only the first step!
kinda nice to be sitting with a company that has one of the world's largest sales force for molecular diagnostics and is spread across the world with great customer relations...
from the gpro call transcript 10/30, ceo talking:
<<Now let me turn to one of our most important pipeline projects, our HPV program for cervical cancer. I�d like to make three points regarding HPV. First, we are very pleased with the analytical and clinical performance of the assay to date.
Some of you may have seen the 220 patient study we conducted with a French opinion leader that was presented earlier this month at the annual meeting of EUROGIN, which if you�re interested, stands for the European Research Organization on Genital Infection and Neoplasia. In this study, our APTIMA HPV assay showed good analytical agreement of about 86% with the one competitive test that is approved in the U.S. Of the 16 samples that were positive by our APTIMA test, but negative based on our competitor�s assay, 12 resolved in our favor when tested with an independent molecular genotyping assay. And of the 15 samples that were negative according to our assay, but positive by our competitor�s test, 12 resolved in our favor when genotyped.
In terms of clinical performance, the sensitivity and specificity of the two assays were statistically comparable in this relatively small patient population. Similar results have been seen in other studies, one of which will be presented next week at an HPV meeting in China. All in all, we believe these data, if confirmed in additional studies, will be very compelling to customers, especially since our HPV test employs familiar APTIMA chemistry on our fully automated TIGRIS system.
Second point regarding HPV is that we have received productive guidance from the FDA on the design of our pivotal clinical trial, and that we believe this guidance is consistent with what our potential competitors have been told. For example, I know that some of you have been concerned that we would be required to follow patients for three years in order to gain approval. After discussing with the FDA, we do not believe that three-year follow up data will be necessary to gain additional approval. Each patient will be tracked for three years, but as we have said before, we believe this can be done after approval, as a post-marketing study. Obviously final approval will be contingent on successfully completing this post-marketing study and on the long-term data confirming the initial results.
In order to gain approval before the three year follow up period, we and our potential competitors have been asked to collect HPV sequencing data on all subject in the study. This new requirement will add expense to our study, but will also contribute to a slight delay in the start of the trial, as we amend the protocol and validate new testing procedures. As such, we now expect the U.S. pivotal study to begin on the first quarter of 2008, rather than the end of this year. Let me emphasize, however, that from this point forward, the rate limiting step in our HPV program is how quickly we are able to enroll the required patients, and what the disease prevalence is in our patient population, especially in the [ASCS] arm of the trial.
The third and final point I want to make about HPV is that we remain on track to launch a CE mark product in Europe in the second half of next year. European performance evaluation studies are underway now, and early reports are positive. As Herm will explain, these studies will contribute to an increase in sales and marketing expense in Q4. We believe the European HPV market is poised for growth, and as I alluded to before, we will be putting additional people on the ground in Europe to attempt to capitalize on this opportunity and develop it further through scientific marketing. So all in all, we�re pleased with the progress of our HPV program, which we think will be an important value driver for us in the medium- to long-term.>>