FJ - what are you smoking? :) The consensus estimates for next quarter is around $8 Million. 25,000 tests would be $12 million by itself. Remember 50% of those 937,000 are already up to date with screening and don't need to be screened this year. Another 25% won't even see their doctor this year. I'd be ecstatic to see 5000. We need to keep our expectations realistic.
Agree Bio - Being a self-insured integrated health insurance networks say alot. They feel this will lower costs without sacrificing quality. That's a big statement - others will follow.
Looked at the public site for WI Mcaid coverage for the G0464 code - Cologuard- and this is what I found:
So Wi mcaid will cover and reimburse $401.60. That's very good in my mind as Mcaid always pays less than Mcare. Granted Mcaid isn't a huge market for Cologuard but there are many people on Mcaid between the ages of 50 and 64 who will now be covered in WI.
Another brick in the wall.
Everyone knows how vital the USPSTF decision is to Exact as an A or B rating will mandate insurance coverage as well as give great publicity and support for docs to order the test. When this will occur is an important question for the speed of Cologuard uptake.
According to the USPSTF website :
"At the Task Force meeting, a representative from the EPC presents the peer-reviewed evidence report findings, and the Task Force leads discuss the evidence and present the draft recommendation statement. The entire Task Force discusses the evidence and recommendation statement. Any proposed changes to the specific language of the recommendation are discussed. The Task Force votes on various formulations of the recommendation statement until one version gains the support needed. It usually takes from 9 to 15 months from the date the work plan is approved to the date the peer-reviewed evidence synthesis and draft recommendation statement are presented to the Task Force for a vote."
The final workplan was approved April 2014. 15 months would be August 2015. Now, I understand this is the "Government" and anything goes. But, we could get a decision before August.
I certainly wouldn't want to be short or out of Exas when the draft recommendations come out.
1) there has never been a randomized controlled trial proving colonoscopy screening decreases mortality - it is just a test at a point in time. Certain assumptions and modelling must be done to make guideline recs - as they will do with CG
2) Maybe FIT would be very good if done yearly - but the fact is it isn't. CG compliance of 75% trumps 3 yearly FIT's of 15%
3) Maybe colonoscopy if done per guidelines would eliminate CRC, but 50% of folks won't do it. Why is it so difficult to understand CG won't necessarily replace colonoscopy but is a good option for those who won't do a colonoscopy or for those like myself at low risk, who have already had a colonoscopy and are willing to accept a slightly decreased sensitivity for the amazing convenience of the test. (Sensitivity will approach or exceed if done every 3 years vs a colonoscopy every 10)
4) False + rate of 13% likely is really much lower as colonoscopy (the comparison gold standard in Deep C) has a false negative rate of at least 5%. So 9/10 people who get CG will get a correct answer.
CG isn't perfect but it is a great option and will greatly help eliminate CRC as part of the screening process.
BIO - Different places give different info. The American Cancer Society says that as of 2013 only 53% of people are Up to date on CRC screening (that includes FOBT')
"half of the US population aged 50 and older (53%) is current for recommended testing."
Many who have had colonoscopies in past are not up to date in terms of #$%$ intervals.
First of all colon cancer is NOT decreasing as you state - colon cancer deaths rates are.
Yes the 30% decline is "likely" due to increased colonoscopy, but rates have also decreased significantly in Europe where they do much less colonoscopy - treatment is also much better.
I admit colonoscopy is good but having the availability to use CG is also very good and if it increases screening rates it can dramatically decrease CRC deaths by much more than 30%.
Kcam - great to hear from you! Glad to see you're following exas. I think we are mimicking the Digene experience. Slower than expected uptake, waiting for some final "standard of care" guidelines, then hit critical mass and off to the races. I think the speed of adoption will exceed HPV testing but patience will win out in the end.
Is your OBGYN group ordering the test and what of your colleagues in Florida?
KCAM - Yeah - I tried to convert the Digene board to Exact as they had some great analytical minds but no one would bite. I remember suggesting it to INCAS when Exact was at 3 but he wasn't interested. I'd love to get his opinion now (and could on the QGEN board) but don't want to be pushy!
You still in SQNM? Had a nice run recently.
DRC KC has addressed this question before and said CG should not pick up upstream cancers. These markers are colon specific. That being said it is new and we don't know what we don't know.
thanks- interesting abstract. So the markers are fairly specific for organ type (but 83% leaves significant room for false + per DRC's idea). Since this wasn't done specifically with CG markers and their FIT algorithm I'm not sure how this would translate to CG. But KC and his team are pretty smart and I imagine they thought this one through so the algorithms eliminate most if not all of the non colon cancers. But, I'm not on the cover of DNA weekly either :)
Sorry quaffer I totally missed it that these were plasma samples!! I thought it was stool - I'll have to take another look
I was thinking - since DEEP C had about 10,000 patients to achieve statistical power, we have already had about 15,000 samples of real world experience. Exact has all of the colonoscopy/pathology data on the CG + patients. We may hear from them that real world CG specificity might be higher than DEEP C. I suspect that when a GI does a Colonoscopy on a CG+ patient they are looking extra carefully for a lesion and will spend more time than they usually would on a low risk patient. If this is the case and specificity is higher than DEEP C that will be a HUGE win and upside surprise for Exact.
Agree Quaff - didn't see any info on precancer or stage of cancer. If they are all stage 3 and 4 then not very valuable. Good to see Exact doing work in the plasma area to stay ahead of the curve.
Biostigg -you are so wrong again. Insurers have been ordering HOME FIT tests for years without the PCP visit to meet HEDIS/NCQA and STARS measures. As soon as USPSTF and NCQA sign off on CG this year insurers will be doing the same thing with CG so they meet their Quality requirements. A Dr visit will NOT be needed. You are only 7 years behind:
Mar 31, 2008
Quest Diagnostics Incorporated , the nation's leading provider of diagnostic testing information and services, today announced the launch of a novel campaign designed to help increase compliance with take-home colorectal screening tests. Titled "It's Time to Challenge Colon Cancer: Do You Have the Guts?," the campaign aims to break down barriers to compliance with fecal occult blood tests and increase screening with these convenient take-home screening tools. The goal of the new campaign is to have five million people complete their annual testing over the next five years.
You are not aware of many things. I have used Quest and have had quality initiatives with them. They are used by many insurers as well as other diagnostic companies doing the same thing. They have a success rate of 10-20% as opposed to Exact at 75%. The reason is that FIT is very low margin and they can't devote resources to compliance. Exact can. Have you been to their call center - I have - it's very impressive. When you get $500/test you can devote resources to compliance. Insurers will used it because they can lock in 3 years of a quality measure hit instead of 1 with Fit. FIT cost is not just $23 it is all the cost to the insurers and doctors pay in trying to meet compliance - that is expensive and Exact makes it free to insurers and providers. That is the value proposition.
Bio - you have very little understanding of clinical medicine - "only the insurer cares about HEDIS, NCQA"- REALLY? Do you know how many Billions of dollars that insurers pay providers in Pay for Performance measures based on HEDIS? Do you know that clinics and hospitals have their HEDIS/NCQA scores open to the public and are very concerned with being in a high performing group? Do you know Hospital system and clinic accreditation is partly based on these HEDIS/NCQA measures. Believe me they are very interested in these measures.
Regarding Kaiser and Geisinger - I'm happy they are successful. But the fact that you can cherry pick a few successful organizations doesn't change the fact that nationally the compliance rate of FIT over a 3 year period is 15% - that is realworld and that is why CG will be successful.