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AACC Cautions FDA Against Over-regulating the Genetic Testing Technology Vital to Precision Medicine

WASHINGTON, March 16, 2015 /PRNewswire-USNewswire/ -- Today AACC sent formal comments to the Food and Drug Administration (FDA) on the agency's proposed regulation of next-generation sequencing tests. AACC appreciates FDA's efforts to seek input from the healthcare community before developing new policy in this area, but is concerned that FDA regulation of next-generation sequencing could impede the advancement of precision medicine. 

Precision medicine uses a person's unique biological makeup, including genetics, to determine which treatments that person would respond to best. Genetic tests hold the potential to predict an individual's risk of developing numerous different conditions throughout life. Having this knowledge could lead one to take a more proactive approach to his or her health, particularly with respect to chronic diseases such as cardiovascular disease and diabetes that could be prevented with basic lifestyle changes. Next-generation sequencing will enhance the application of precision medicine by making genetic testing more readily available.

After reviewing FDA's preliminary discussion paper on the topic, "Optimizing FDA's Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests," AACC recommends that oversight of next-generation sequencing remain under the Clinical Laboratory Improvement Amendments (CLIA) like other laboratory developed tests. CLIA-regulated laboratories conducting next-generation sequencing testing are experienced in developing, verifying, and performing clinical tests. AACC believes that CLIA-recognized accrediting bodies and professional societies should continue to take the lead in providing oversight and guidance for next-generation sequencing testing in the absence of specific, identified problems with this approach.  

"AACC agrees with the FDA that next-generation sequencing tests offer great opportunities for advancing laboratory medicine and improving patient care, and we commend the agency's efforts to initiate a dialogue among the various organizations and professionals involved in next-generation sequencing and those affected by such testing," said AACC President Dr. David D. Koch. "We believe, however, that the current oversight mechanisms in place for next-generation sequencing are sufficient for dealing with the particular challenges this technology presents and that further FDA involvement at this time might hinder the advancement of this field." 

Read AACC's comment letter here

About AACC 
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit

Molly Polen
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