The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Almac is developing the assay to enroll patients for clinical trials used to develop repotrectinib, an investigational tyrosine kinase inhibitor.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.
The researchers combined different proteomic methods to explore the activity of the ALK inhibitor ceritinib and identify potential combination therapies.
Researchers identified unique ALK rearrangements in patients that lack previously known indicators of mesothelioma.
Patients are organizing themselves in groups based on the molecular features driving their tumors to better advocate for themselves, raise money, and influence research.
Investigators will use Biocept's liquid biopsy tests to detect ALK rearrangements both at baseline and to monitor treatment response and resistance mechanisms.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
Reuters reports that UK researchers are using gene-editing tools to develop flu-resistant chickens.
Nature calls for genomics to become part of the World Health Organization's cholera surveillance approach.
Vox explores a proposal to institute a lottery system to award grant funds.
In Genome Biology this week: gut microbiome study of individuals from Tanzania and Botswana, sixth version of the Network of Cancer Genes database, and more.