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.
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.
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 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.
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.
