regulatory approval | GenomeWeb

regulatory approval

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.

The diagnostic, a real-time PCR kit for breast cancer stratification, is being reviewed under a special process for the approval of innovative products.

The NGS-based assays will be implemented at Memorial Sloan Kettering Cancer Center alongside targeted DNA sequencing assays to identify gene fusions.

The test, EXaCT-1, may not only help doctors find treatments for patients who have run out of options but may also provide biomarkers of immunotherapy response.

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In PLOS this week: nasal microbial communities in asthma patients; sequencing-based way to detect, track schistosomiasis; and more.

The New York Times speaks with Vanderbilt's John Anthony Capra about Neanderthal genes in modern humans.

A draft guidance from the FDA suggests the agency wants to more tightly control gene-edited animals, according to Technology Review.

Researchers were among this weekend's protesters bemoaning the new US administration, Vox reports.