Breast Cancer
Genomic Health to Pay $32.5M to Resolve Cancer Test False Claims Allegations by DOJ
The settlement includes the resolution of allegations brought in two separate actions filed against the firm under the whistleblower provisions of the False Claims Act.
Natera Submits Signatera Bladder Cancer PMA Module to FDA
The module relates to manufacturing and quality control systems for Signatera as a CDx in muscle-invasive bladder cancer.
FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test
The Invitae Common Hereditary Cancers Panel is the first test of its kind to obtain FDA marketing authorization, creating an easier pathway for similar tests.
Myriad Genetics, Memorial Sloan Kettering Partner to Study MRD Testing in Breast Cancer
The collaborators will evaluate the use of Myriad's MRD platform in predicting response to CDK4/6 inhibitors and in a chemotherapy neoadjuvant setting.
I-SPY 2 Trial to Evaluate Natera's Signatera for Post-Neoadjuvant Breast Cancer Monitoring
Researchers will evaluate the MRD test's ability to monitor neoadjuvant treatment response in 600 breast cancer patients in real time.