"it is clear we are dealing with people of dubious ethics"... XD Ironic much Kande?
Given that the stock went up 16.5% on the day, I'd say their "control" was lacking.
I've heard this theory before, that the Madison City Council is going to hold a local company's feet to the fire forcing them to hire employees per their agreement and in so doing put the company out of business. Think about that for a minute. Do you think city government is going to get anything out of putting a local company, that's getting a lot of press for themselves and the city and is a significant source of tax revenue and jobs, out of business? I don't think so, they'll work something out that's in keeping with the reality of whatever market conditions Exact faces.
No City is going to force a high profile local employer to go out of business by imposing onerous conditions on them, all the political incentives work against this. That's why there's so much local opposition to this deal, people understand that when push comes to shove the businesses will get what they want from local government.
I think some of the confusion about what the USPSTF rating means comes out of the fact that the draft document is so ambiguous. If this task force's recommendations are now going to carry legal weight in terms of mandating insurance converage, this group is going to have to up their game some.
Changing all of the classifications around and then leaving them so murky and poorly defined might have worked back when this group's recommendations were just another set of guidlines; but now they're going to have to be rigorous in their definitions and clear in implications of their classifications. Otherwise they'll spark a bunch of lawsuits about whether or not insurance has to cover the screening tests they reviewed. What does "alternative" mean in terms of coverage mandates? I think frustration with this was evident in Kevin's presentation at the quarterly CC.
I think Exact's tactic will be to ask the USPSTF committee to make clear that insurance coverage is mandated for "alternative" tests when the conditions (vague as they are) for using the alternative tests are met.
You know if that's what you read in that quote you're welcome to your opinion. Everyone else can read it and form their own opinion.
I think it's pretty clear what: "...under the Affordable Care Act all services that are A rated, and Cologuard is one of those services now, have to be covered under the Affordable Care Act." means, it means the ACA requires insurers to cover Cologuard.
I think you're looking for this quote given by Kevin Conroy in response to Mark Massaro from Canaccord Genuity:
"You know, one final thing is that payers I think are -- will recognize the reality that as an A rated screening service, Cologuard being listed in USPSTF draft guidelines eventually it will impact how they think about coverage because under the Affordable Care Act all services that are A rated, and Cologuard is one of those services now, have to be covered under the Affordable Care Act."
"The responsibility for this decision lies with the company and the company only."
So, in your opinion, the esteemed members of this panel aren't even responsible for their own decision? I think the whole point of the USPSTF methodology is to take the "company input" out of the decision making process. This is supposed to be evidence based medicine. But when you ignore and/or inaccurately model the most important data-point in CRC screening today: Compliance, you get a result that doesn't fit the reality of the situation. The poor compliance data for annual FIT/FoBT (~35%) well documented in several studies.
The decision to ignore compliance in making this decision rests squarely on the shoulders the USPSTF panel.
I think that's really the crux of the USPSTF document's shortcomings. There are lots of screening methods, and the motivated patients are already taken care of. Advances in treating CRC will come from getting non-compliant patients *effectively* screened that's where all the action is right now. This report has no relevance to the current reality of CRC screening.
Championing a stool test that has a poor single test detection rate and requires the patient to keep coming back for repeated annual testing in order to be effective as a means of screening non-compliant patients is silly, and it's an obvious silly.
Maybe I misunderstood Jim's question. My post is to answer the question "Why have the test (Cologuard) "standard of care" rather than just colonscopy".
Here's why (taken directly from the USPSTF draft report):
"The harms of stool-based tests primarily result from adverse events associated with colonoscopy performed for the followup of positive screening results...
Colonoscopy has both indirect and direct harms. Harms may be caused by the bowel cleanout prior to the procedure (e.g., dehydration and electrolyte imbalances), the sedation used during the procedure (e.g., cardiovascular events), or the procedure itself (e.g., infection, colonic perforations, or bleeding)."
I've decided to put this header on every repost of a message that gets deleted
***This post has been deleted [X] times by those who want to suppress information and manipulate this stock ***
***This post has been deleted 2 times by those who want to supress information and manipulate this stock price***
Every supressor of information has a little self-righteous rationale for their actions don't they. Amazing that "protecting" all us innocents also happens to be in your financial interests.
Shorts are flagging posts they don't like as offensive and getting them deleted. Happened to me 3 times today. This is a major push for them and the manipulation is heavy.
Since apparently the shorts are getting any post that contradicts their little fairy tales flagged and deleted, I'm gonna try this again.
The problems with this ruling:
• The USPSTF task force, in its guidance document, indicates that detecting adenomas and high grade dysplasia are an important target of the screening programs it's reviewing. Yet the panel used a specificity number for cologuard: 84.4% that counted detecting adenomas and high grade dysplasia as a false positive. The specificity for Cologuard that is in keeping with the panel's own guidelines is 89.8%, which would significantly change the evaluation of this product.
• The panel used 1 year interval testing for Cologuard as the point of comparison with other tests, yet all recommendations from the company and medical community are for a 3 year interval. Using the recommended 3 year interval and the correct specificity would have put Cologuard right on the efficient frontier in their modeling, which was the criteria for inclusion in group A.
• Colonoscopy had to be considered in its own category because it required over 4,049 colonoscopies (colonoscopies were considered "Harms" in the other analyses) to achieve Lives Saved and Years saved. This is almost twice as many as even the worst competing test and almost 2.5x as many as 3yr interval Cologuard. This was far out of proportion to the gain colonoscopy afforded over the other tests in lives and life years saved.
I don't know if I agree with the idea that CG would increase the number of colonoscopies. If you look at the analysis done by this committee all of these tests (including CG) produce far fewer colonoscopies per patient than just using colonoscopy itself as the screen method. Cologuard on a 3 yr interval reduced colonoscopies per patient to less than half that of colonoscopy alone. CG would have to bring about 3x as many new patients to screening that otherwise wouldn't have gotten it before colonoscopies would increase.
EXAS is no stranger to blood testing, they've explored this avenue pretty thoroughly. I'm sure they continue to. They didn't worry much about Epi because they were familiar with the lack/low concentrations of mutated DNA in blood in early cancer stages.
If blood testing becomes viable it will likely as not be EXAS that comes up with it, given their deep reach into academia related to genetic markers.