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News Breaks
February 5, 2014
09:01 EDTEXASFDA confirms date for Exact Sciences' advisory committee
Exact Sciences announced that the U.S. Food and Drug Administration has confirmed by notice in the Federal Register that its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will review the premarket approval application for the company’s Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 27.
News For EXAS From The Last 14 Days
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December 19, 2014
17:32 EDTEXASCMS provides update on reimbursement for Cologuard
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15:48 EDTEXASExact Sciences CMS lobbying may take several months, says Maxim
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15:33 EDTEXASExact Sciences says working with CMS to clarify Cologuard reimbursement
Exact Sciences said the reimbursement amount published today for Cologuard in the 2015 Clinical Diagnostic Laboratory Fee Schedule is inconsistent with what the Centers for Medicare and Medicaid Services, or CMS, publicly communicated on November 25 when CMS issued a final payment decision for Cologuard using the crosswalk methodology to CPT codes 81315, 81275, and 82274. Utilizing the crosswalk methodology based on the updated 2015 fee schedule the total for these codes is $500.76. Exact Sciences is working with CMS to clarify and will communicate more information once it becomes available. CMS has a process to establish payment rates for clinical laboratory tests and Exact Sciences followed that process. On July 11, Exact Sciences proposed a crosswalk methodology for Cologuard to CPT codes, 82274, 81275 and 81315. CMS agreed with that crosswalk methodology when they published their preliminary payment recommendation on October 11. CMS received public comments on that recommendation and on November 25 published their final recommendation which affirmed the crosswalk methodology, the company noted.
15:06 EDTEXASExact Sciences CMS confusion seen as clerical error, says Canaccord
Canaccord said management of Exact Sciences are attributing confusion around the code used for reimbursement of its Cologuard test to a clerical error at CMS and that the company has reached out to resolve the issue. A national diagnostics expert also said the CMS update is likely a clerical error, the firm noted. Canaccord has a Buy rating and $30 price target on Exact Sciences.
12:58 EDTEXASExact Sciences slips amid questions on Cologuard reimbursement
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December 16, 2014
09:16 EDTEXASOn The Fly: Pre-market Movers
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09:05 EDTEXASExact Sciences 4M share Spot Secondary priced at $25.75
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December 15, 2014
16:15 EDTEXASExact Sciences files automatic mixed securities shelf
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16:09 EDTEXASExact Sciences files to sell 4M shares of common stock
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December 11, 2014
14:43 EDTEXASExact Sciences management to meet with William Blair
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