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A consortium convened by Friends of Cancer Research has made progress in quantifying sources of TMB assay discordance and created a new test-alignment software tool.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
Backed by BARDA, Merck and Institute for Systems Biology are studying multiomic data to understand infection pathways and find biomarkers for symptom risk.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The multi-omics translational software developer is helping the Crohn's & Colitis Foundation validate its research into biomarkers that can predict complications requiring surgery.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
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