Foundation Medicine

The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.

The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.

Chugai, a member of the Roche Group, has already filed for regulatory approval of FoundationOne CDx with Japan's Ministry of Health, Labor, and Welfare.

These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.

The companies also agreed to establish a working group to explore the development of standard formulas and definitions for the validation of genomic profiling assays.

The company plans to grow its business based on the FDA approval and preliminary national coverage determination for its FoundationOne CDx test last year. 

For full-year 2017, the company reported $152.9 million in revenues, up 31 percent over 2016.

The GenomeWeb Index outperformed the Nasdaq Biotechnology Index, which lost 5 percent in February, but lost the same amount as the Dow.

With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.

A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.


Berkeley researchers have engineered yeast to make the molecule behind the hoppy taste of beer, Quartz reports.

King's College London researchers examine the influence of school type and genetics on academic achievement.

FiveThirtyEight writes that most who take a direct-to-consumer BRCA1/2 genetic test won't learn much from it.

In Science this week: early life experience influence somatic variation in the genome, and more.