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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.

The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.

The tubes and collection kits meet the requirements of the European In-Vitro Diagnostic Devices Directive, and the company can now commercialize the devices throughout Europe.

Due out in December, the Magnis automated library prep instrument is meant to be an affordable and easy way for researchers to use Agilent's SureSelect kits.

The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.

Bioethicists disagree with a research team's decision to allow the return of risk results for adult-onset conditions from a newborn sequencing project, according to Reuters.

Alterations to particular gene may enable the Quechua of Peru to better tolerate high-altitude life, Ars Technica reports.

Nature News reports that additional South Korean researchers have included the names of children on scientific papers when they did not contribute to the work.

In PLOS this week: statistical approach to prioritize rare variant searches, gene expression alterations in chronic obstructive pulmonary disease, and more.