Feature | Genetic Testing | September 21, 2015

FDA Taking Genomic Testing to the Next Level

Agency to host public workshops on development of evaluative standards and curated databases for next-generation sequencing-based clinical tests

genomic testing, NGS, FDA, Precision Medicine Initiative, PMI, workshops

September 21, 2015 — The U.S. Food and Drug Administration (FDA) will hold a pair of public workshops in November to explain ongoing efforts to develop regulations and standards for next-generation sequencing (NGS)-based clinical tests. The focus on NGS tests is part of President Obama’s Precision Medicine Initiative (PMI) to help customize healthcare for individuals based on genetic makeup.

Many current efforts toward healthcare customization have focused on analyzing and interpreting a person’s unique genetic makeup, according to Adam C. Berger, Ph.D., senior staff fellow on the Personalized Medicine Staff at FDA’s Office of In Vitro Diagnostics and Radiological Health. In a post on the FDA blog FDAVoice — co-written with Zivana Tezak, Ph.D., associate director for science and technology in the same office — Berger noted NGS technologies have significantly advanced the ability to derive more comprehensive genetic information on individuals in a relatively inexpensive and fast manner.

The first workshop, held Nov. 12, will focus on analytical performance evaluation standards, including potential ways to develop these standards, which can be used by test developers to ensure their tests produce accurate, reliable results.

The second workshop, held Nov. 13, will address current challenges in clinical validation of NGS tests. A single company, lab or institution is unlikely to have enough information to definitively determine the clinical importance of test results. The aggregation of clinical information in curated databases will create a “data commons” that could serve as a reliable source of scientific evidence that test developers could use to demonstrate that NGS test results are relevant to a person’s disease or outcome. The workshop will highlight how scientists, patient groups, and private industry can work together to develop high-quality, curated clinical databases of genomic information that associate specific genetic changes with various diseases, such as cardiovascular disease or diabetes.

FDA first addressed the issue in December 2014 in a preliminary discussion paper, describing how it might go about creating a modern, flexible and dynamic regulatory system for NGS, which could potentially be applied to many other types of genomic tests. The agency received comments from a variety of stakeholders at a February 2015 workshop

In advance of these workshops, FDA will be releasing additional discussion papers informed by public input, which will also include some general questions for stakeholder consideration. 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.

For more information: www.fda.gov

Related Content

Livongo Launches Applied Health Signals Product Category
News | Cardiac Diagnostics | November 30, 2018
Healthcare technology company Livongo recently announced the launch of its Applied Health Signals product category,...
HHS Releases Second Edition of Physical Activity Guidelines for Americans. #AHA2018 #AHA18
News | Cardiac Diagnostics | November 14, 2018
The U.S. Department of Health and Human Services (HHS) released the second edition of the Physical Activity Guidelines...
ACC and AHA Release Updated Cholesterol Guidelines for 2018. #AHA18 #AHA2018
Feature | Cardiac Diagnostics | November 13, 2018
November 13, 2018 — New cholesterol guidelines from the American Heart Association (AHA) and the American College of
AMI READMITS Score Predicts Heart Attack Patients at High Readmission Risk
News | Cardiac Diagnostics | October 09, 2018
Tracking just seven factors of heart attack patients when they are first admitted to the hospital can help flag those...
Siemens Healthineers Showcases New In Vivo and In Vitro Cardiovascular Solutions at TCT 2018
News | Cardiac Diagnostics | September 21, 2018
At the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, Siemens Healthineers...
Weight Loss Drug Does Not Increase Cardiovascular Events
News | Cardiac Diagnostics | August 31, 2018
A weight loss drug does not increase cardiovascular events, according to late breaking results from the CAMELLIA-TIMI...
Acarix Presents CADScor System at ESC 2018
News | Cardiac Diagnostics | August 27, 2018
Acarix AB’s ultra-sensitive acoustic CADScor System for coronary artery disease risk assessment will be on display at...
NIH Ending Funding for Moderate Alcohol and Cardiovascular Health Trial
News | Cardiac Diagnostics | August 24, 2018
The National Institutes of Health announced in June it plans to end funding to the Moderate Alcohol and Cardiovascular...
Study Shows Multiple Benefits of Patient-to-Patient Connectivity in Familial Chylomicronemia Syndrome
News | Cardiac Diagnostics | August 07, 2018
Akcea Therapeutics Inc., an affiliate of Ionis Pharmaceuticals Inc., announced the publication of results from the...
Being Overweight May Change Young Adults' Heart Structure, Function
News | Cardiac Diagnostics | August 03, 2018
Even as a young adult, being overweight may cause higher blood pressure and thicken heart muscle, setting the stage for...
Overlay Init