publication date: Aug. 8, 2014

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By Paul Goldberg

It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.

It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.

The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”

The whistleblowers allege that their former employer violated the federal anti-kickback statute by routinely waiving some of its fees to induce referrals to federal healthcare programs.

The complaint alleges that Caris instructed sales representatives to market the tests to surgeons, who often make the initial clinical diagnosis of cancer. While surgeons are able to extract the tumor samples and order the test, they don’t necessarily know whether an oncologist, who would be seeing the patient at a later point, would consider such tests necessary.

“Caris demanded that its sales representatives call on surgeons to obtain tissue specimens, regardless of the treatment history of the patient and regardless of whether the treating oncologist requested the test or planned to use it in determining treatment,” the complaint states.

The suit, filed in the U.S. District Court for the Northern District of Texas, Dallas Division, also alleges that over one very hot summer, Caris ran tests on hematology specimens that were compromised by … Continue reading 40-32 “Wild West” of Molecular Testing?

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