oldguy and Steph - I have no scientific basis for my example, It was just a hypothetical to suggest that modelling and real life outcomes are not always the same and the best scientific studies are ones that don't use surrogate markers based solely on histology but real patient oriented outcomes like injury and death. The perfect example is prostate cancer and PSA testing. 5 years ago it was malpractice not to detect all prostate cancers using PSA and now the USPSTF gives it a "D" recommendation and says it is harmful. - and NO I'm not comparing CG to PSA or Prosate Cancer to CRC!! so hold the replies.
Just trying to make the point that modelling and Outcome studies are both useful but different and agencies like USPSTF look at them differently. My last comment on the topic.
Yes, the modelling is better but that is not "real world" Example is HPV testing for Cervical cancer. It has been standard of care for 10-15 years but USPSTF only approved it a few years ago as they wanted outcome data. Modelling was not sufficient at the time for them. I agree with you that it makes sense to give an A rating in this situation but just because you can detect more of something doesn't always mean it's better.
I know it is HIGHLY unlikely but what if one of the DNA tumor markers CG uses is for some reason associated with extremely slow growing cancers and will rarely cause death on it's own - detection of these might be unfavorable to cancer outcomes if all these folks get surgery and chemo and radiation. Best to understand how USPSTF thinks. I still predict an "A" though.
Steph - USPSTF has always placed a high value on outcome data - that is studies over time which have actually shown a reduction in morbidity/mortality and other patient outcomes. CG has clearly shown superiority to FIT in detection but it has not been around long enough to prove outcome benefit. FOBT's have shown morbidity/mortality benefits. That being said USPSTF realizes you can't always wait 5 years to see if a test like CG has outcome benefits so they do modelling. That's the next best thing.
They gave Colonoscopy an A rating before any outcome benefits were seen so they may do the same for CG but it is something they put into the equation.
The likely choices are A, B or I (insufficient evidence for or against). D is more harm than good - likely not in the mix. A or B are almost equally as good as they require mandatory coverage. B is possible since Exas has no "outcome" studies yet like FOBT/FIT has. But, hopefully their modelling will overcome this and give an A.
Aetna updated their CRC screening guidelines 8/7/15 and unfortunately continued to state CG is experimental. Looks like they won't budge until they are forced by the USPSTF. Next update listed in 6/16. Market doesn't seem to mind.
I was just surfing the web at a non medical site and 2 Cologuard ads pop up that are directed to physicians only. Medical lingo and how to sign up. I guess it might not be tough to connect internet dots but I was pretty surprised they knew the ad would be seen by a Dr. I've never seen that before for any other medical device or drug. Cool !
You are right Oldguy - the EXAS story isn't complicated. Patients and docs love the test. The main issue now is commercial coverage and the fact that insurers don't get Quality Measure credit for using CG (per NCQA/HEDIS) and are not required to cover CG. Once USPSTF is A or B, both issues will be resolved. Stock will soar or get crushed with that decision. I think chances of A or B are 90% so I'm in.
What incentive? How about good patient care? It's illegal to get kickbacks for ordering tests. Don't have a very high opinions of Drs., do you? :)
less than 50 years old and the performance of CG. I'm sure someone is looking into it.
New study-Prev Chronic Dis. 2015;12(5)
ABSTRACT: Screening of first-degree relatives of CRC patients is recommended to begin at age 40 or 10 years before the age at diagnosis of the youngest relative diagnosed with CRC. CRC incidence has increased recently among younger Americans while it has declined among older Americans. The objective of this study was to determine whether first-degree relatives of CRC patients are being screened according to recommended guidelines.
CONCLUSIONS: Despite a 5-fold increase in colonoscopy screening rates since 2005, rates among first-degree relatives younger than the conventional screening age have lagged. Screening promotion targeted to this group may halt the recent rising trend of CRC among younger Americans.
Hmmm - 40 yr olds don't want a colonoscopy. Wonder if there is an alternative? :) Would be nice to see data of archived stool specimens on those
Good Aetna find Trader. Interesting that in their policy they approve screening African Americans at age 45 as medically necessary which is NOT a USPSTF recommendation so they obviously are not using USPSTF as there sole source of truth. Makes you wonder if they approve CG will they approve it for AA's at age 45 even though that would be off label?
Jim - it's not the cost of imaging that's the problem it's the lack of specificity. Only 4 out of a hundred suspected lesions turn out to be lung cancer and alot of follow up testing is needed to prove that (besides the radiation exposure to #$%$ on these lesions)