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FDA Proposes New Approach for the Regulation of NGS-Based Genetic Testing

In February of 2015, the US Food and Drug Administration (FDA) released a nine-page paper entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests—Preliminary Discussion Paper” that, among other ideas, proposed allowing the use of curated third-party databases to support submissions for FDA approval, rather than requiring new studies and the support of existing literature.

This represents a noteworthy change in the way diagnostic tests may be developed: the evidence supporting the clinical relevance of results will come from the community, not from the test developer!

Topic: Industry News, Content: Blog

Genetic Progress or Genetic Danger?


In early February, Great Britain’s House of Commons followed a historic debate with a vote approving a 2015 amendment to the 2008 Human Fertilization and Embryology Act. The new modification allows an additional person to donate mitochondrial DNA for In Vitro Fertilization (IVF) babies. The mitochondrial DNA donation from a third person is just 0.054 percent of the baby's entire DNA, but is able to protect from serious genetic diseases.

Topic: Industry News, Content: Blog

The Road to Personalized Medicine: FDA's Proposed Guidelines on Companion Diagnostics


While regulation of diagnostic tests by the Food and Drug Administration (FDA) may not directly impact the biobanking industry, it does have an impact on the development of new therapies, particularly personalized medicine, and all of us have a stake in the future of personalized medicine.

The FDA is actively encouraging the development of personalized medicine and regenerative therapies, and has taken a significant step on behalf of companies that are developing these products by enforcing regulatory oversight of the corresponding diagnostic tests. The FDA's August 2014 announcement,  In Vitro Companion Diagnostic Devices / Guidance for Industry and Food and Drug Administration Staff, provided further guidance to those companies developing therapeutic products and/or in vitro companion diagnostics.  Shortly after this announcement was made the FDA sent a proposed risk-based framework for regulatory oversight to Congress for approval.

Topic: Industry News, Content: Blog