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.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
A genetic genealogy analysis helped secure the release of a California man from prison after getting his murder conviction overturned, the Guardian reports.
Technology Review discusses the concerns that come along with the ability to quickly synthesize viruses like SARS-CoV-2.
Researchers have uncovered large bacteriophages whose genomes include translational machinery, Live Science reports.
In PNAS this week: role for Myc in alternative splicing regulation in prostate cancer, variation in methylation in Arabidopsis, and more.