The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
The company, established as a merger between A*STAR MedTech spin-off MiRXES and venture capital firm Venturecraft, has developed a blood test for early-stage stomach cancer.
The company said that 20 medical centers in the US are now offering the Envisia Genomic Classifier through an early-access program begun in May.
The funding is being provided to a number of early-career investigators and collaborative research groups using genomics and other technologies.
Researchers were able to identify 40 tumor-specific antigens within two mouse cancer cell lines and seven human primary tumors using this approach.
New research suggests that the physicochemical changes to DNA in a cancer-related methylation landscape can alter a DNA molecule's affinity for gold substrates.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The company said its test is the first biomarker-based diagnostic for IBD that predicts long-term disease outcome in Crohn's disease and ulcerative colitis.
The endorsement is the agency's first through the Human Variant Database Program, for which it released final guidance earlier this year.
The data generated by 100,000 Genomes Project is being housed on military servers due to attacks by hackers, Naked Security reports.
A new poll finds most US adults are not familiar with personalized medicine, according to HealthDay.
Vox reports that the United Nations' Convention on Biological Diversity decided against a gene drive moratorium.
In Science this week: sequencing of neuroblastomas uncovers alterations linked to prognosis, and more.