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
Trg - even worst case scenario and USPSTF keeps it as an acceptable "alternative" test I think HEDIS will have to accept it as valid since it is an approved alternative test. Payers will go crazy if they pay $500 and it doesn't count towards their quality measures- especially since it's an every 3 year test. JMHO.
Spoke with someone who was at a recent NCQA meeting where they were discussing measure specs for 2016. I don't think they make decisions until the summer but they said there was ALOT of talk from payers about including CG in the new specs for CRC screening. It would likely be retroactive for all of calendar year 2016.