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The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.

Move It Along

In a speech to Congress, President Donald Trump called the drug approval process at FDA "slow and burdensome."

The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.

Little Bit Slower Now

Reuters reports that drug approvals in the US are at a low, but that might reflect a return to previous activity levels.

The company can now offer its Clinical Exome and Pediatric Neurology Region of Interest diagnostic tests in New York.

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

The test can now be used to screen for sickle cell trait, a condition in which an individual carries one of the two abnormal genes responsible for sickle cell disease.


The state has given its approval for the company to market its ThyGenX next-generation sequencing oncogene panel for indeterminate thyroid nodules.

The test can now be used to detect EGFR mutations in tissue and blood for lung cancer patients considering treatment with the tyrosine kinase inhibiting drugs Tarceva and Tagrisso. 

The company said it is confident it can address the state health department's concerns and will reapply for approval as soon as possible.

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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.