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The drugmaker will cover the cost of testing for up to 500 patients in the US with MSI-high colorectal cancer or RAI-refractory differentiated thyroid cancer.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
The company has formalized an existing relationship by acquiring Pharmatech, hoping to directly integrate the firm's "right on time" trial matching service with its own molecular testing.
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.
The overlapping development programs for first-generation larotrectinib and second-generation LOXO-195 signal narrowing drug development timelines in the era of precision oncology.
The firm's new RT-PCR assay identifies 20 gene fusion between NTRK1/2/3 and other genes, allowing clinicians to potentially detect rare forms of different cancers.
In order to be eligible for the drug, patients must have NTRK fusions, which may be determined via various tests including NGS and FISH.
President Donald Trump might not approve the stricter standards the US Food and Drug Administration is developing for authorizing a SARS-CoV-2 vaccine, according to Politico.
Wired reports that Oxitec has now developed a genetically modified fall armyworm.
A large genetic study finds SARS-CoV-2 viruses with a certain variant are spreading more than others, according to the Washington Post.
In Nature this week: sister-chromatid-sensitive chromosome conformation capture approach, and more.