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regulatory approval

AbbVie researchers validated and extended a previous study to find different types of genetic evidence have varying influences on approval prospects.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

Illumina and PacBio wrote that the agency "has failed to establish that Illumina's short-read systems and PacBio's native long-read systems compete."

The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.

In a notice posted on its website, the Competition and Markets Authority said it is extending its inquiry, with a new deadline of Feb. 5, 2020.

Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.

Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.

It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.

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

The program will likely only generate sequencing data, not genotyping array data, for returning health-related results to reduce the complexity associated with two platforms.

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ScienceInsider reports that rude and unprofessional paper reviewers are common and can have harmful effects.

The US Senate has confirmed Stephen Hahn as the next commissioner of the Food and Drug Administration, according to the New York Times.

CNBC reports Apple is partnering with Color Genomics to offer its employees free DNA screening for disease.

In Science this week: researchers use CRISPR tool to find gut microbiome molecules involved in immunity, and more.