Ben Harmssen

FoundationOne CDx Comprehensive Genomic Profiling for Solid Tumors Now Commercially Available

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Foundation Medicine Announces Commercial Availability of FoundationOne CDx, the First FDA-Approved Comprehensive Genomic Profiling Assay for All Solid Tumors Incorporating Multiple Companion Diagnostics.

Genetic Counselor Ordering Companion Diagnostic Test

Foundation Medicine, Inc. announced on March 30th, 2018 that FoundationOne CDx(TM), the first U.S. Food and Drug Administration (FDA) approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. Read more →

Ben Harmssen

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

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The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. To find out if you or your patients carry the BRCA gene mutation and if they are eligible for Lynparza or other personalized treatment options contact MyOncoPath’s genetic counselors. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.

Breast Cancer Stats for BRCA Genetic Mutation & Mammograms

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Ben Harmssen

FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers

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FDA Announces Approval of FoundationOne CDx, Foundation Medicine’s Cancer Gene Diagnostic Test for Solid Tumors FDA approves test to detect mutations in 324 genes, two genomic signatures. Second to be approved with proposed coverage under FDA/CMS Parallel Review Program. Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to […]

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