Posts From the monthly archives: "December 2014"

BRCA1 and BRCA2 have been considered important risk factor biomarkers for breast cancer since at least the release of Myriad’sBRACAnalysis™ 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 treatment for that disease…(Read More)

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. The Committee posted a white paper on December 9 that lists eleven broad questions covering everything from the definition of a diagnostic device, to risk definitions, to what…(Read More)

Good news regarding a new personalized cancer therapy that has just been approved after showing very strong efficacy during clinical trials. Blinatumomab is a novel CD19-directed immunotherapy from Amgen that is a great example of personalized medicine in action. It is a treatment for leukemia patients who are negative for the Philadelphia chromosome biomarker…(Read More)


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