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.
MolecularMD is expected to expand Icon's laboratory services by enabling it to better support precision medicine programs for drug-diagnostic codevelopment.
Companies are developing metabolomic tests both to aid in early diagnosis of the condition and to help guide treatment in patients with metabolic imbalances.
The company said RNA-seq will enable it to detect therapeutically relevant gene fusions better than DNA sequencing tests.
The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.
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.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
The firm has also begun an initiative to reduce and deliver sustainable revenue growth for 2019 to compensate for commercial challenges in the US market.
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.