Research & Development
Pathology & AI
Companion Diagnostics: Page 2
FYR, Medicover partner to expand into North America
The collaboration will support pharmaceutical companies with clinical trial assay development and implementation, codevelopment of novel diagnostic technologies, and companion diagnostic testing services.
August 30, 2022
Myriad Genetics CDx nabs expanded coverage in Japan
BRACAnalysis classifies a patient's clinically significant DNA sequence variations in the germline BRCA1 and BRCA2 genes.
August 25, 2022
Roche CDx assay receives CE label expansion
The announcement came after the conclusion of a Phase III study sponsored by Genentech that observed the efficacy of Tecentriq in treating patients with NSCLC.
August 23, 2022
Pillar Biosciences colon cancer test gets Chinese approval
The clearance adds China to the company's other markets for the test, which include the U.S. and Europe.
August 21, 2022
FYR Dx, Medicover partner on assay, tech development
The firms plan to support pharmaceutical companies with clinical trial assay development and implementation, codevelopment of novel diagnostic technologies, and companion diagnostic testing services.
August 16, 2022
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
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Netherlands researchers combine CRISPR, bioluminescence in proof-of-concept infectious disease test
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
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
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
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