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More articles about Companion Diagnostics

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.

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 firm anticipates deploying funds to complete the integration of Biosensia, a developer of multi-analyte assays on a CLIA-waived testing platform.

The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.

The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.

Plans are in place for a Guardant360-based assay to predict response to AsztraZeneca's Tagrisso and for a blood-based TMB test using the larger GuardantOmni panel.

The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.

The quantitative immunoassay measures the concentration of a novel antibiotic, plazomicin (Zemdri), using the automated clinical chemistry analyzer Beckman Coulter AU 680.

The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.

The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.

The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.

Qiagen will provide IUO tests for NeoGenomics to verify, set up, and run in clinical trials and in anticipation of regulatory approval.

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