There was a nice upward trend in a down market today, but I think this stock doesn't really take off without ACS inclusion, the release of Itzkowitz data, or some fresh news on the CMS application or the FDA. Where do we stand on these issues? Here is my take.
1. ACS guidelines -- The first question is when will they be released. I think late December or early January. They weren't published in the Nov/Dec issue of CA, so that means they'll probably be out in the Jan issue, which is the issue where previous updates to the guidelines have been published. The second question is whether fDNA will be included. I think yes. First, there is a concerted effort in the public health community to increase screening for cancer. fDNA fits the bill. Second the world guidelines included fDNA. It makes no sense to include fDNA in the world guidelines and not the US guidelines. Only the US and possibly Europe are going to use fDNA anytime soon. The US members of the committee had to be the driving force behind the inclusion, and these are the same people that are making the ACS guidelines.
2. Itzkowitz. Obviously this will be released this quarter. I expect sensitivity of about 82-85% and specificity of 80-90%. I doubt they will improve upon the numbers presented in the original pilot. In the larger study they will be testing two markers instead of testing a number of markers and picking the best two. Also, Luber set the stage for an ~80% sensitivity in his presentation today. Nonetheless, this will be an important validation. Will it be a significant improvement over iFOBT? I don't know. Judging by the first paper, it will be more sensitive, but with a lower specificity (iFOBT specificity is typically 95%)
3. FDA. Don't have a clue here. I think 6 months minimum, based on Luber's talk.
I predict Itzkowitz in the next two months, then ACS guidelines in January, then FDA in last half of 08.
I think the stock move a little with Itzkowitz, jumps to 12 with ACS, and then, who knows?
1) I believe that FIT makes gFOBT redundant, and will therefore cause the gFOBT to be dropped from the guidelines. However, since not all CRC's bleed, and early stage adenomas almost never do, the sDNA test wins in its ability to find adenomas instead of just CRC's. In addition, it is more user friendly. However, at present, I see room for both of the FIT and the sDNA tests.
Since this test is geared towards average-risk individuals, I believe the true test will be the one that is better at detecting adenomas. Here is where sDNA's strength lies, and it is up to EXAS and LH to market its potential here! It because of its ability to detect adenomas, and thus screen out large populations from needless colonoscopies, which will cause the ACS to consider sDNA for inclusion.
2) I feel your expectations for S&S for V2 are in line, based upon today's CC. (the more samples you have the smoother your results, not the the higher your results). Again, I feel the key here is picking up adenomas and not just CRCs, it will be interesting to see what those S&S's are.
3) As far as the FDA is concerned, I agree. Don't forget the 501k is for V1, not V2, but like any governmental agency, bet on longer rather than earlier. I could see an ACS recommendation coincide with an FDA and CMS recommendation, if all goes well. Remember, we were just waiting for a peek at guidelines. The actual guidelines will not be out until next year.
The Itzkowitz study results should be out this quarter, but I believe Jeff Luber gave us an idea of what to expect today during the CC. I think we are starting to see the stock move on the anticipated Itskowitz' numbers mentioned at today's CC. I am not even going to guess any further than that, but we could see back above the $5 mark over the next couple of months!
>I believe the true test will be the one that is better at detecting adenomas.
I agree with this statement 100%. A non-invasive test that can detect adenomas with a high degree of sensitivity would be a significant advance.
But, I don't know of any evidence that suggests PreGen V1 or V2 can detect adenomas with any real sensitivity. Do you? In the Imperiale study, the sensitivity of v1 to adenomas was 15% versus 10% for gFOBT. Furthermore, if I recall correctly, the difference wasn't statistically significant. The Itzkowitz study did not report any numbers for adenomas. Finally, there are some reports of iFOBT detecting adenomas with sensitivities in the mid 60s (see Int J Cancer. 2006 Jun 15;118(12):3078-83.)
Do you have any more data on that topic? It's funny you bring adenomas up as a strength of fDNA, because I view it as one of the main weakness of the technology, at least as currently reported in the literature.
How about a partnership and $30M upfront deal with Roche or JNJ once the FDA clarifies the filing strategy for V1, which then leads to V2 filing pathway - supported by pending trial results this quarter. I'm expecting a 510(k) de novo route along with the reproducibility study outlined during the presentation. Could wrap up the entire FDA process within 6 months if everything goes according to plan, although 9 months might be a safer estimate since we are dealing with the FDA. Hopefully the FDA provides positive feedback shortly to the pre-IDE filed 11/2/07 so the 510(k) gets filed & the process begins.
That's a pretty decent summary. You could add the CMS approval too I suppose.
Also, there's no reason guidelines will have to wait for the next CA. We understand they are voting in November and could be published anywhere. As I understand when they were last revised in 2003, they were first published in one of the Gastro journals, followed a couple months later by CA.