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Inside Track: Blazing a New Trail

The Cologuard colorectal cancer screening test is the first product to make it through a new pilot program that offers parallel review of medical devices and diagnostics by both the Food and Drug Administration and the Centers for Medicare & Medicaid Services.

Barthelemy

Breast Cancer Index Awarded Medicare Coverage

After a positive evaluation by Palmetto GBA, CMS has approved coverage of the molecular diagnostic to predict risk of recurrence and drug therapy benefit in breast cancer patients.

Sample application for a VeriStrat assay by Biodesix.

Highmark Insurance Company Announces Coverage for VeriStrat Assay

One of the largest insurance companies in the United States, Highmark has announced it will begin providing coverage of the VeriStrat assay to guide second-line treatment decisions for patients with non-small cell lung cancer. Coverage takes effect on October 27, 2014.