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national coverage determination

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

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.

The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.

Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.

Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.

The FDA approved FoundationOne CDx and the Centers for Medicare and Medicaid Services concurrently issued a proposed national coverage decision for the test.

After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.

The new agreement brings Interpace's total insurance coverage for its thyroid assays to approximately 200 million patients.

While undergoing parallel review for its FoundationOne test by the FDA and CMS, the firm will continue to work with its local MACs on reimbursement.

The company hopes to simultaneously achieve premarket FDA approval and a national coverage determination from CMS for its NGS cancer panel.

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The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.