FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests


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Margaret A. Hamburg, MD

Jeffrey Shuren, MD

[The recent] action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.

—Margaret A. Hamburg, MD
The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs.

—Jeffrey Shuren, MD

The U.S. Food and Drug Administration (FDA) recently took important steps to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent, and reliable results.

First, the FDA is issuing a final guidance on the development, review, and approval or clearance of companion diagnostics, tests used to identify patients who will benefit from or be harmed by treatment with a certain drug.

Second, consistent with the requirements of the FDA Safety and Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests, which are designed, manufactured, and used within a single laboratory.

“Ensuring that doctors and patients have access to safe, accurate, and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, MD. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. [The recent] action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

Companion Diagnostics Guidance

Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers. The companion diagnostics guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time. The ultimate goal of the final guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases. This guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.

Laboratory Developed Tests

Laboratory developed tests (LDTs) include some genetic tests and tests that are used by health-care professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are lab-developed tests or traditional diagnostics. While the FDA has historically exercised enforcement discretion over lab-developed tests(generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use. The LDT notification to Congress provides the anticipated details of the draft guidance through which the agency would propose to establish an LDT oversight framework, including premarket review for higher-risk Lab-developed tests, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. The draft guidance would also propose to phase in enforcement of premarket review for other high risk and moderate risk lab-developed tests over time.

The agency intends to propose continuing to exercise enforcement discretion for low-risk lab-developed tests, lab-developed tests for rare diseases and, under certain circumstances, lab-developed tests for which there is no FDA-approved or cleared test.

Balanced Approach for All Diagnostics

“With [the recent] notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs,” said Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health.

The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using lab-developed tests, how to provide information about their lab-developed tests, and how they can comply with the medical device reporting requirements. ■


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