Roche will develop an immunohistochemistry-based companion diagnostic for Daiichi's investigational HER2-targeting antibody conjugate for breast cancer.
The company submitted the test to Japanese regulators for approval as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
1Drop anticipates the platform will be capable of handling up to 64 clinical biomarkers, including indicators of cardiovascular diseases and many others.
The new firm, TaiRx US, is developing a drug and companion Dx for the nodal protein, which has been linked to aggressiveness and resistance in multiple cancers.
Under one agreement, LabCorp will help Baptist Health establish a core lab. Its deal with Definiens is aimed at companion diagnostics development.
Celcuity's HER2 assay will be used to assess Puma Bio's Nerlynx and chemotherapy on patients with early-stage triple-negative breast cancer.
The collaboration agreement includes support for development, regulatory submission, and commercialization of tests to guide use of Novartis' drug portfolio.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
Early initiatives of the new network will focus on companion diagnostics and the pathogen preparedness.
Archer will develop and pursue regulatory approval for a companion diagnostic that will help find patients who may benefit from one of Merck's drug candidates.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
The partners will make a test for monitoring Tysabri available to clinicians and clinical trial partners through ResearchDx's reference laboratory.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.
The firm's next-generation sequencing diagnostic test analyzes tumor samples from multiple genomic mutations that are targeted by therapies for non-small cell lung cancer.
Clew Medical aggregates data from multiple devices and information systems to identify and refine patterns that indicate patient deterioration.
In addition, Qiagen has partnered with Japan's SRL for companion diagnostic development, and its CareHPV test was added to the WHO list of prequalified IVDs.