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FDA Director for Diagnostic Tests to Discuss the Agency's Proposed Framework to Oversee Laboratory Developed Tests

WASHINGTON, Sept. 8, 2014 /PRNewswire-USNewswire/ -- On September 10, AACC will host a webinar with Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health to explain the agency's long-awaited proposal for oversight of laboratory developed tests (LDTs). LDTs play an integral role in diagnosing a wide range of medical conditions, including congenital disorders, infectious diseases, drug abuse, and cancer.

WHO:           Dr. Alberto Gutierrez has been director of FDA's Office of In Vitro Diagnostics and Radiological Health since 2009, and is a leading expert in ensuring the safety and efficacy of medical tests.

WHEN:         Wednesday, September 10

                    2–3 p.m.

WHERE:       The New Guidance on LDTs: A Q&A With the FDA

WHY:           Regulating LDTs could benefit patients by ensuring that widely used commercial LDTs are safe and effective, but there are concerns it could also impede the ability of labs to diagnose conditions for which no FDA-approved test exists.

LDTs are medical tests that are created and used within a single lab, and are often developed to fulfill unmet clinical needs, e.g. to diagnose rare diseases for which no FDA-authorized test exists. The FDA has had the authority to regulate LDTs as devices since 1976, when Congress passed the Medical Device Amendments of 1976 that gave the agency authority to regulate all in vitro diagnostics as devices. While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use. In July, the agency notified Congress that it intends to issue draft guidance on LDTs, and also detailed its proposal for establishing a risk-based oversight framework for these tests.

FDA seeks to ensure that LDTs are properly validated; otherwise, these tests might give incorrect diagnoses and result in patient harm by leading patients to undergo unnecessary—or forego necessary—treatment. This is especially a concern now that an increasing number of biotech corporations are manufacturing LDTs and selling them to the public (as opposed to traditional LDTs, which were often only available to a single hospital's patients). For instance, Myriad Genetics' well-known BRCA mutation test for breast cancer is considered an LDT and has never gone through the FDA review process.

However, labs worry that the time and expense that the FDA approval process involves might hinder the ability of labs to develop tests that meet urgent patient needs. Labs must often create LDTs with very little notice when a patient presents with a life-threatening condition that no existing test can identify. Additionally, hospital and other small laboratories might not have the financial resources to apply for FDA approval. Labs fear these constraints could limit future LDT development, and may also force them to discontinue the LDTs that they currently use.

In AACC's webinar, Dr. Gutierrez will address these concerns and will discuss how the proposed risk-based oversight framework will affect the ability of labs to perform these tests.

HOW:  To attend this webinar as press, for interviews, or additional information please contact Molly Polen, AACC Director of Communications & PR, at 202.420.7612 or

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
Director of Communications & PR
(p) 202.420.7612
(c) 703.598.0472

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