Entries by Ben Harmssen

FDA Finalizes Next Generation Sequencing Genetic Tests to Accelerate Reliable Development

FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests The U.S. Food and Drug Administration on April 12th finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide […]

FoundationOne CDx Comprehensive Genomic Profiling for Solid Tumors Now Commercially Available

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

Precision Medicine, Genetic Testing & Targeted Therapies are Expanding Oncology Treatment Opportunities

This is an in depth review of the American Society of Clinical Oncology’s (ASCO) panel on their State of Cancer in America annual report released January 31st, 2018. MyOncoPath is dedicated to providing cancer patients and oncology providers with genetic counseling for somatic and diagnostic genetic testing to expand access to precision medicine.

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

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 […]

Keytruda Immunotherapy FDA Approval – Cancer Treatment for Tumors with Specific Genetic Markers

In May 2017 the FDA granted accelerated approval to an immunotherapy cancer treatment for patients whose cancers have a specific genetic feature (biomarker). This approval marked the first time the FDA approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda is a cancer […]

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

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 […]

Benefits of Telemedicine in Genetic Counseling for Cancer Patients & Providers

The Use of Telecommunications to Improve Access to Cancer Treatments For many telemedicine is new and possibly unknown. Although telemedicine has been around since the 1950’s, today telemedicine is growing exponentially with an overall net benefit. Here at MyOncoPath telemedicine is our business model: we were founded with the goal of providing patients and health […]

Immunotherapy Cancer Treatment Options Available Through Genetic Testing

 An Immunotherapy targets a cancer patient’s immune system with the goal of activating the immune system to attack cancer cells, where as a chemotherapy, generally kills cells that are reproducing (hence some of the side effects like hair loss are common).  Immunotherapy is a type of cancer treatment that boost’s the body’s immune defenses to fight […]