The study plans to recruit close to 300 patients with advanced non-small cell lung cancer, with half being treated based on liquid biopsy results.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
Researchers are collecting genomic and clinical data on cancer patients outside of clinical trials to understand tumor biology, treatment efficacy, and care gaps.
In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
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 new guidelines said ROS1, KRAS, BRAF, MET, RET, and HER2 should be included in targeted and expanded panels.
Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic.
Patients are organizing themselves in groups based on the molecular features driving their tumors to better advocate for themselves, raise money, and influence research.
NPR reports that many USDA researchers working at the two agencies that are relocating to the Kansas City area are declining to go.
Genetic genealogy has helped exonerate a man who has been jailed for 20 years, Agence France Presse reports.
A new report says genetically modified food might be necessary to be able to feed a planet of nearly 10 billion people, Bloomberg says.
In Nature this week: new RNA editing approach called LEAPER, draft assembly of Musa balbisiana banana genome, and more.