Tuesday, November 08, 2016 11:49:42 AM
'And our first question is from the line of Dana Flanders with JPMorgan.
Dana Flanders
Hi, thank you for the questions. Just my first one on the 4Kscore, so just with the local covers decision from Palmetto now finalized just what are your steps forward there? Is that just you are going to try to provide additional data to try to get them to reverse the decision or just some additional clarity on what you can actually do? And then secondarily would you expect that decision to impact Novitas at all or are those relatively independent in your eyes? And then I have a follow-up.
David Okrongly
Hi Dana, this is Dave Okrongly I’ll take the question. So, with Palmetto the idea is to provide them with new information the literature is continuing to evolve on 4K in a very positive way. As you recall one of their issues was PSAs greater than 10. In the journal of urology in September this year there was a fine paper published about the 4Kscore and it’s used in men with a positive DRE or PSA between 10 and 25. And obviously the conclusion of that paper was that the test performed very well there as it had in our prospective clinical trial in the United States.
We also have another paper that came out it’s a retrospective study, but it’s a very important cohort it’s the prostate long colorectal ovarian group and again the 4Kscore test preformed exceeding well in this group of men which was actually coincidently a group of men that was part of the invention arm of that study and it was a very import study for looking at PSA as a screening test.
We performed very well on that study as well, all this new data is going to be presented to Palmetto so that we can continue to provide additional evidence to get them to overturn the negative coverage decision. With Novitas we’re working with them and as Steve mentioned we expect the February review cycle to be the next time we’ll hear from Novitas and we’ve provided them with lots of information that we think more than adequately demonstrates the reason why Medicare is and should continue to pay for the 4Kscore test."
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