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Cytek said that the approval places the company on a path to offering a complete spectral flow cytometry solution — including instruments and reagents — to customers in China.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.
Ortho's assay, which aids in quickly and accurately diagnosing heart attacks, runs on its new Vitros XT 7600 Integrated System, among other Ortho systems.
The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The firm said that the system's automation and flexibility will help centers be more productive within a testing specialty that can require extensive hands-on time.