The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
Almac said that the assay will be used in a clinical study of repotrectinib (TPX-0005), an investigational, next-generation tyrosine kinase inhibitor.
The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.
Eurofins Scientific will help Adial validate a companion diagnostic for a drug being developed and identify patients for enrollment into a Phase III trial.
The next-generation sequencing assay is intended for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors.
Organizations including Quest, J&J, Medecision, and the ACCP have formed the Get the Medications Right (GTMRx) Institute to promote PGx testing.
The agency wants to waive the "substantial clinical improvement" criteria for medical devices for two years and increase the add-on payment.
The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.
Qiagen's "Day-One" lab readiness program is designed to expedite patient access to its CDx tests following regulatory approval of the tests and associated drugs.
The companies will combine their respective technologies to create a biomarker and companion diagnostic development service for pharmaceutical customers.
LabCorp's Covance business plans to offer single-cell services on Mission Bio's platform to pharma and to explore its use in companion diagnostics.
The test will be designed to detect a protein biomarker in aqueous humor that can be used to determine the severity of glaucoma and to make treatment decisions.
The deal will focus on Biocartis' Idylla MSI test, which provides information on a tumor's microsatellite instability status of a tumor from a single FFPE slice.
The test can now be used to identify triple-negative breast cancer patients who are likely to benefit from the immunotherapy Tecentriq plus chemotherapy.
The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.
The NGS assay is designed to help physicians to identify non-small cell lung cancer patients who may benefit from eight targeted therapies.