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 recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.

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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.

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