regulatory approval | GenomeWeb

regulatory approval

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.

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.

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In Science this week: genetic target for urothelial bladder cancer treatment, and more.

At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.

Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.

Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.