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ROS1 Biomarkers

News and reporting on ROS1 biomarkers.

The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.

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. 

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NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.

According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.

A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.

In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.