ExonHit Therapeutics today announced that Medicare is maintaining coverage of RedPath Integrated Technology's pancreatic cancer test.
ExonHit had announced in April its plans to acquire RedPath for up to $32 million, but since Highmark Medicare Services — a contractor for the Centers for Medicare and Medicaid Services — said in June that it intended to drop coverage of the PathFinderTG-Pancreatic Cancer test, depending on an assessment of the test, the deal has been on hold.
In a statement today, ExonHit said that Highmark decided to continue coverage for the test "as a reasonable and necessary" service only in instances when the first line diagnostic evaluation for pancreatic cyst or mass is inconclusive.
As a requirement for this, RedPath is being asked to maintain and populate a Medicare-specific database of all Medicare patients for whom PathFinder is being used as a diagnostic tool. The information is to be collected beginning on Jan. 1, 2011 and will be provided to CMS every six months.
HighMark's decision applies to the PathFinderTG-Pancreatic Cancer test performed on or after Nov. 5.
In ExonHit's statement, Loic Maurel, president of the company's management board, said the decision by Highmark acknowledges the clinical utility of the PathFinder test as a second line test when standard pathology test are inconclusive, and added that ExonHit and RedPath will "evaluate the impact of this decision," in the coming days.