Research & Development
Pathology & AI
Companion Diagnostics: Page 2
Kronos, Invivoscribe to develop CDx for entospeltinib
The CDx will screen for the NPM1 mutation, which is present in approximately one-third of all patients with AML.
August 16, 2022
Thermo Fisher, Guardant Health get approval for NSCLC CDx
Enhertu is an HER2-directed antibody drug conjugate being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
August 11, 2022
FDA approves label expansion for Roche CDx
The label expansion follows the FDA approval in April 2021 of the Ventana MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy Jemperli (dostarlimab-gxly).
August 10, 2022
BD, Labcorp to develop flow cytometry CDx
Specifically, the agreement creates a framework for BD and Labcorp Drug Development to collaborate on flow cytometry-based CDx opportunities with pharmaceutical partners.
August 8, 2022
CAP issues guideline to improve immunotherapy treatment
The CAP guideline is evidence-based and joins a small number of testing methods based on both the methodology and the status of the biomarker -- i.e., microsatellite testing and deficient mismatch repair process assessment. This stands in contrast to previous guidelines that focused on the cancer type or tumor origin.
August 4, 2022
Exact Sciences subsidiary nabs FDA clearance for CDx
The CDx confirms variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
June 29, 2022
DNA forensic evidence frees Ohio man of rape, attempted rape
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
AnchorDx enrolling U.S. clinical trial for bladder cancer assay
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Akoya, Acrivon to develop CDx for cancer treatment
OncoSignature identifies cancer patients likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy that Acrivon is developing.
June 28, 2022
Biocartis, AstraZeneca to develop CDx for EGFR TKI treatment
The firms aim to obtain applicable premarket notification or approval from the U.S. Food and Drug Administration (FDA) for a CDx test on Biocartis' fully automated molecular Idylla platform.
June 21, 2022
CDx Diagnostics, Avalon ink in-network lab agreement
The agreement makes CDx's diagnostic platform, WATS3D, available to the 565,000 members of BCBS of South Carolina, including all of its commercial and Medicare Advantage plans.
June 13, 2022
Foundation Medicine gets FDA nod for NSCLC CDx
Rozlytrek is a targeted therapy for the treatment of non-small cell lung cancer (NSCLC) developed by Roche's Genentech.
June 8, 2022
Grail, AstraZeneca to collaborate on companion diagnostic tests
The firms will focus first on developing CDx tests using Grail's methylation platform to identify and recruit patients with high-risk, early-stage cancer for AstraZeneca's clinical studies.
June 1, 2022
Illumina wins new indication for TruSight Oncology in Europe
Launched in March initially in Europe, TruSight Oncology Comprehensive (EU) assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer, according to the company. The CDx pan-cancer indication will enable identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2, or NTRK3, and who may benefit from targeted therapy with Bayer's Vitravki (larotrectinib) drug.
May 24, 2022
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