The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
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 [email protected], will create a research platform that could change the way cardiovascular diseases are diagnosed and treated.