Sorry the Meta-analysis conclusion was cut off:
"Conclusion Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative detection of colorectal cancer in the distal colon than in the proximal bowel."
Nothing new to us but the more folks know this problem with FIT and that CG gets proximal lesions as well as distal lesions the better.
Aliment Pharmacol Ther. 2016;43(7):755-764.
Abstract and Introduction
Background The performance of faecal occult blood tests (FOBTs) to screen proximally located colorectal cancer (CRC) has produced inconsistent results.
Aim To assess in a meta-analysis, the diagnostic accuracy of FOBTs for relative detection of CRC according to anatomical location of CRC.
Methods Diagnostic studies including both symptomatic and asymptomatic cohorts assessing performance of FOBTs for CRC were searched from MEDINE and EMBASE. Primary outcome was accuracy of FOBTs according to the anatomical location of CRC. Bivariate random-effects model was used. Subgroup analyses were performed to evaluate test performance of guaiac-based FOBT (gFOBT) and immunochemical-based FOBT (iFOBT).
Results Thirteen studies, with 17 cohorts, reporting performance of FOBT were included; a total of 26 342 patients (mean age 58.9 years; 58.1% male) underwent both colonoscopy and FOBT. Pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of FOBTs for CRC detection in the proximal colon were 71.2% (95% CI 61.3–79.4%), 93.6% (95% CI 90.7–95.7%), 11.1 (95% CI 7.8–15.8) and 0.3 (95% CI 0.2–0.4) respectively. Corresponding findings for CRC detection in distal colon were 80.1% (95% CI 70.9–87.0%), 93.6% (95% CI 90.7–95.7%), 12.6 (95% CI 8.8–18.1) and 0.2 (95% CI 0.1–0.3). The area-under-curve for FOBT detection for proximal and distal CRC were 90% vs. 94% (P = 0.0143). Both gFOBT and iFOBT showed significantly lower sensitivity but comparable specificity for the detection of proximally located CRC compared with distal CRC.
Conclusion Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative
From the FDA:
"Regarding whether or not the test is effective, five panel members voted yes, and six, no. Regarding whether or not its benefits outweigh its risks, five panel members voted yes; four, no; and one abstained.
At the time, several panel members voiced concern about use of the Epi proColon test for screening, especially insofar as the test failed to perform better than the fecal immunochemical test (FIT)."
Quite the overwhelming endorsement- not.
Scorekeeper. I'm not sure what you're saying is correct. Yes Medicare covers CG but STARS criteria for CRC screening are based on HEDIS guidelines. Hedis guidelines only approve the following tests:
1.FOBT during the measurement year
2.Flexible sigmoidoscopy during the measurement year or during the four years prior
3.Double contrast barium enema during the measurement year or during the four years prior
4.Colonoscopy during the measurement year or during the nine years prior
CG codes are not included
So if you are a Mcare Advantage or SNP plan you are NOT getting credit for CG toward your STARS score even if you cover the test. That's one reason Mcare advantage plans are reluctant to sign on.
What does HEDIS use as part of their decision making process to include CG - the USPSTF!! So -you see how this is interconnected and even hurting Mcare coverage.
Hopefully HEDIS will agree to cover CG when they review this later this year and include CG - that will help.
One- sonoran Not quite a zero sum game. The commercial carriers assume many of those cancer dx's will occur after 65 so it will be on Medicares dime.
one _sonoran- In terms of insurers anything that isn't mandatory will go through an extensive cost/benefit analysis. Working against exas is that CG is not included in Quality Metrics, and that the potential future savings of lower cancer treatment bills is many years off. That member probably won't even be theirs in 5 years.In CG favor is colonoscopy is expensive and has potential expensive complications.
I think KC and his team have been great in general. The one area they fell short in is not understanding the insurance issue early enough, not understanding the HEDIS/STARS QI issue and misjudging USPSTF.
I felt years ago they should make the price $300 and get all the insurers on board quickly. Maybe in the long run they will be proven correct?
As a primary care doc and experience in the insurance world and a long time EXAS invester I would rank the following issues in order of importance as to the slower than expected uptake.
1. Big shifts in medicine take time - it's a little over a year since launch. Physician need to be educated and change practice patterns that have been entrenched for decades.
2. Lack of insurance coverage is huge - Physicians don't want to take the time and responsibility to figure out if a patient is covered or not or if they will get stuck with a bill
3. USPSTF decision is related to # 2 in the long run
4. Also related to #2 - Insurance companies must meet CRC screening guidelines for important quality scores. NCQA/HEDIS have not approved CG in their screening so insurers will not get credit for the test. This will result in potentially punitive results. Thus slower adoption.
5. Patient demand is important but that takes time and $ with DTC advertising
6. The price is too high if not covered by insurance and some Docs are also trying to keep costs of medicine down and see $500 as excessive.
Is it a buy? Depends if you believe KC
I just listened to the call. The primary reason for the drop was they said Q1 would be similar to Q4. That is bad.
We had 34k test in q3, 38k in q 4, and predicting 38K in Q1 (or a little more). That means 200k in the last 3 quarters to hit 240K. That's an average of 66k a quarter. If you believe what KC said that things have normalized and that Q2 and Q3 will be strong like last year then it's a buy. If you don't believe him and think growth is significantly slowing then it's a sell. We probably don't know the answer until the Q1 call when we get an update on sales.
Schmidh1- Yes HPV is only for women. But, don't forget at the time women began getting Paps from about age 18 or so to age 70. CG is 50-75. So the Paps were actually a larger population.
Julian - I listened to the call. I agree with KC's perspective. He basically says:
1) the USPSTF doesn't give letter ratings to tests
2) the USPSTF gives an "A" rating to CRC screening 50-75 with different tests
3) CG is listed as one of these tests - albeit "alternative"
4) The ACA requires all "A" and "B" rated tests to be covered
5) Therefore, CG should be a required covered test after the final report is out
The biggest job now is Insurance coverage because even if docs and patients are educated (and they are doing a very good job of that) if they aren't covered it will slow uptake.
In my mind almost all of the bad news is baked into the stock. As insurance covers expands so will sales and eventually everyone will cover it and Exas will be a big winner. I went through the same thing with Thin prep and Cytec and HPV and Digene. They were both big winners - just took patience, and we are ahead of both of them in terms of speed of uptake. I like when KC said there is no visible competition for 10 years. We will be rewarded.
It worked through the IR link now. We all need to voice our opinion to Mgt.
Oldguy - do you know if modified CG eliminates the FIT or just changes the cut points for a +? Thanks
Valpo - it's not recommended because it has been studies only in average risk populations- Deep C. That is why they are running the IBD study to see if it works well in IBD patients. It's not contraindicated per se, it's just not approved for this indication and your doc is using it off label. If CG were to miss a cancer he would be at risk. You would think a Neg would be very reassuring, but you might have more false +'s with the FIT component due to the bleeding nature of IBD. That being said if someone with IBD absolutely refuses colonoscopy it seems reasonable to use CG as long as there is consent. IMO, best to wait for the study results to go that route.
It is usually done by 2 months after the comment period ends, but I heard someone say KC said it wouldn't be until later in 2016 because of the volume of comments they had. Sooner the better and I personally view the delay as more of a + than a -.in term of the decision.
Just viewed an very good 11 minute presentation on QuantiaMD (has 200,000 registered medical providers) on CG done by a Mayo GI doc. Very positive presentation. Interesting that they asked how familiar they were with the test - about 20% said "very", 40% a little, and 35% "not" (other were N/A). These were no doubt a wide variety of providers but shows lots of room for awareness and expansion and great marketing to 200k providers.
Ranjo- Thanks for the update. I haven't listened to the call. Per USPSTF they will normally issue guidance 1-2 months after the Public Comment period ends. If they are going to delay the decision because of so much push back then I would expect the recommendations to change somewhat. I think KC is just being conservative as always. At the least the USPSTF needs to clarify A,B,I, recommended and alternative and I think the worst is baked in and any surprise is on the upside. Why take an extra year and not change anything?
Highly unlikely they get an "I". This is just a statement of the current recommendations since the 2015 Draft decision is not yet final