FDA Takes Genomic Testing a Step Further with Regulatory Strategies & Public Workshops

September 16, 2015

FDA has announced plans to develop diagnostic systems for the use of next generation sequencing (NGS) technologies, furthering the Precision Medicine Initiative (PMI) ordered by President Obama. The goal and mission of the PMI is “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments.” This is precisely what FDA plans to do by developing regulatory strategies for NGS-based clinical test.

Next generation sequencing refers to the grouping of millions of small fragments of DNA that can then be sequenced at the same time, creating enormous amounts of data. This is a significant advancement because it enables the sequencing of an entire genome, as well as created the ability to diagnose, and possibly predict, multiple conditions using only one test. This advancement s derives more comprehensive genetic information on individuals at a relatively inexpensive price point.

Starting last year, FDA has been seeking input on how a regulatory system could be developed for use in the review and regulation of NGS technologies. After running into several issues, releasing a discussion paper on the data created by these tests, and holding a public workshop, FDA has announced its plans to hold two additional workshops. These workshops will be held on November 12 and 13 and will focus on developing a regulatory system for NGS technologies.

On November 12, the workshop will address the standards for analytical performance evaluation of NGS. FDA is hoping to gain feedback as well as discuss “possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize its regulatory approach to NGS-based in vitro diagnostic tests (IVDs).” The standards to be developed will be used to ensure accurate and reliable test results are produced by test developers.

On November 13, FDA will cover the “current challenges in clinical validation of NGS tests.” The purpose of this workshop is for the Agency to get comments and feedback on how it can “use curated databases containing information about human genetic variation as sources of valid clinical evidence” for its oversight of the NGS-based IVDs. FDA acknowledges that a “single company, lab, or institution is unlikely to have enough information to definitively determine the clinical importance of test results,” but is hoping that by compiling all of the information into a database, a reliable source of scientific evidence will be created.

FDA has announced plans to publish additional discussion papers that will be based on public input received by the Agency. These documents will “provide a high level overview of regulatory considerations for the development of analytical standards and the use of curated clinical databases to support NGS test submissions” and will be available prior to the two workshops.

For the last 35 years, we have been helping our clients achieve successful interactions with the FDA and have established a strong relationship with the Agency over the years.  We have the knowledge and experience you need to develop and submit a successful application.  Contact us today to learn more about our services and how we can help you.


March 9, 2016

FDA to Review PhUSE Nonclinical Study Data Reviewer’s Guide Template

As a part of its ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), the FDA has announced its plans to review the proposed Nonclinical Study Data Reviewer’s Guide (SDRG)...

March 7, 2016

FDA Takes Steps to Ensure Patients are Informed of Safety Risks Associated with Essure

Additional information on FDA's review of Essure is available in our previous FDA News article entitled "Coming Soon: FDA Safety Review of Essure" On Monday, February 29th, FDA announced that it will...

March 1, 2016

Rare Disease Day 2016: FDA Announces Grants for Natural History Studies in Rare Diseases

On Monday, February 29th, FDA celebrated the ninth annual Rare Disease Day by announcing its new grant program, which will award $2 million in research grants to fund natural history studies for rare...