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.
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.
Results from the phase 3 ADMIRAL trial were announced during the American Association for Cancer Research annual meeting.
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.
Although analyses for other drugs in the class have failed to confirm the influence of genotype, Dalcor is moving forward with its clinical trial, expecting some results by the end of this year.
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 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.
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.
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.
Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
New research shows that scientists need to do a better job of including a wider diversity of African genomes in their analyses, STAT says.
A new paper in Science shows that men are still winning a large majority of the most sought-after NIH grants.
Nature Research and the Estée Lauder Companies are awarding efforts to encourage girls to pursue careers in the STEM fields.
In Science this week: beneficial genetic variants inherited from archaic Neanderthal and Denisovan hominins, and more.