The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
The collaboration agreement includes support for development, regulatory submission, and commercialization of tests to guide use of Novartis' drug portfolio.
The companion diagnostic test identifies patients taking the Novartis drug Tasigna who are candidates for treatment-free remission monitoring.
Quest will also have early access to Thermo Fisher's pipeline of novel platforms and assays to assist with development of Oncomine-branded solutions.
The test measures minimal residual disease and can be used to monitor patients eligible for discontinuation of treatment with Tasigna.
Backed by €19 million in EU funding, the initiative, called BigData@Heart, will create a research platform that could change the way cardiovascular diseases are diagnosed and treated.
The approved Ventana ALK (D5F3) immunohistochemistry CDx is available for use on the Roche BenchMark XT or BenchMark Ultra IHC/ISH slide staining systems.
The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.