publication date: Oct. 3, 2014

 

Past Coverage of Laboratory-Developed Tests

“Wild West” of Molecular Testing? Caris Engaged in Aggressive Marketing, Improper Medicare Billing, Lawsuit Alleges

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.

Conversation with The Cancer Letter:
Daniel Hayes Leads Tour of Caris Website

Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.

Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Caris Officials Respond To Questions Submitted By The Cancer Letter

The Cancer Letter submitted seven questions to Caris Life Sciences regarding their suite of molecular diagnostic tests. 

Questions focused on the costs of the tests, who pays for them, and how much of the information they provide is actionable.

AACR Urges FDA to Regulate High Risk Lab-Developed Tests

The American Association for Cancer Research urged FDA to regulate high-risk laboratory-developed tests, a category of assays that has escaped scrutiny because of loopholes in the regulatory process.

Normally, FDA requires that diagnostic tests developed by manufacturers adhere to three measures: analytic validity, clinical validity, and clinical utility. However, laboratories can get around this requirement by using laboratory-developed tests, or LDTs.

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