BRCA1 and BRCA2 Now Validated for Companion Diagnostic Use

BRCA1 and BRCA2 have been considered important risk factor biomarkers for breast cancer since at least the release of Myriad's BRACAnalysis™ test in 1996, but to-date they have only been used for identifying people who are at high risk of developing breast cancer, and have not been used to guide ...

House Committee Seeks Feedback on LDT Regulation

by John Audette | Dec 11, 2014 | LDT Regulation, News, Regulation

The House Energy and Commerce Committee is soliciting feedback from "all interested stakeholders" on just about every central issue related to FDA's proposal to regulate LDTs.

FDA Approves Blinatumomab for Acute Lymphoblastic Leukemia

Good news regarding a new personalized cancer therapy that has just been approved after showing very strong efficacy during clinical trials.




Pharmacovigilance and Safety Biomarkers

New Call-to-action

Subscribe for Updates

Download our Free IVD Trends Report