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Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.
The firm's subsidiary BioReference Laboratories performed 3.5 million COVID-19 PCR tests and 300,000 serology tests during the quarter.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
News items for the in vitro diagnostics industry for the week of Oct. 5, 2020
PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.
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 firm reported that test volumes for its Cologuard colorectal cancer screening test also rose 79 percent year over year.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
Test volume for the firm's Cologuard colorectal cancer screening test rose 49 percent year over year during the quarter.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.