From the Earnings Call transcript
Steven Rubin,"....Moving on to progress for 4Kscore, our innovative blood test that predicts the probability of aggressive prostate cancer, we continue to work with payers to secure favorable reimbursement and are making incremental progress. Last year, the American Medical Association granted a CPT 1 code for 4Kscore, which will be effective as of January 1, 2017.
We have a number of pricing agreements already in place with payers. We are continuing to work with Novitas Solutions to reinstate their positive local coverage decision or LCD. Novitas is the Medicare Administrative Contractor or MAC that governs our BioReference facility in New Jersey where we run the 4Kscore test. We have submitted a complete clinical dossier in Novitas which included background information, physician experience and extensive clinical validation.
We expect Novitas to include 4Kscore in its February review cycle for a draft local coverage determination. In the meantime Novitas has been and continues to pay for 4Kscore Medicare submissions. We remain confident in a positive LCD from Novitas for 4Kscore as there is ample clinical validation to support favorable reimbursement as supported by numerous published peer reviewed studies and the inclusion of the U.S. national comprehensive cancer and network guidelines for prostate cancer early detection and in the European association of urology prostate cancer guidelines panel for 2016 EAU guidelines for prostate cancer.
We also continue to work with Palmetto to address their concerns as you know while Palmetto does not administrate Medicare submissions for the 4Kscore because our laboratory is not within their region, they nevertheless issued a negative LCD on 4Kscore. As we previously reported 4Kscore’s currently being marketed by approximately 200 BRL sales reps to both urologists and primary care physicians. We continue to see growing test volume remain very encouraged by the increasing physician use of the test.
During the quarter ended September 30, 2016 approximately 16,000 4Kscore tests were performed. A 9% increase from the quarter ended June 30, 2016 and a 365% increase over the comparable period of 2015. Which leads me next to a discussion of our plans for the Claros 1 point-of-care system, our novel multiplex instrument system to provide rapid high performance blood test result at the point-of-care."
