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regulatory approval

Following the premarket authorization of 23andMe's tests, the agency may allow other firms to sell similar tests DTC without having to submit them for review.

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).

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

The firm registered the Novaprep HQ+ Orange vial as a class I device with the US FDA, while the CFDA approved the Novaprep system for non-gynecological testing. 

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

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.

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