FDA looks to make companion diagnostics, lab tests more reliable



Last month, the Food and Drug Administration announced the latest steps it is taking to advance the use of personalized medicine.

First, the agency finalized guidance on the development of companion diagnostics. Second, it signaled its intent to begin oversight of certain laboratory developed tests (LDTs), tests that are designed, manufactured, and used within a single laboratory.

The guidance, initially issued as a draft in July 2011, offers the agency’s thinking on its expectations on the development of companion diagnostics. No substantive changes were made to the final guidance document from its draft version, agency officials said.

"When drug companies develop therapies that will only work on specific subpopulations, it’s important those therapies are approved with a diagnostic test that the FDA knows is accurate and reliable and patients and their physicians can count on," FDA Commissioner Dr. Margaret Hamburg said during a press teleconference.

The agency also revealed its initial thoughts on how it will regulate LDTs in a letter to Congress. The FDA is required to let Congress know 60 days prior to the issuance of draft and final guidance. The forthcoming draft represents a change in how the agency is approaching LDTs.

"The FDA has historically exercised enforcement discretion over LDTs, meaning the agency generally did not enforce applicable regulatory requirements on the tests because they were generally considered lower risk and used on a limited basis within a given institution," Dr. Hamburg said. "Today, they may be marketed and used more broadly and compete with FDA-approved tests without clinical studies to support their use. The deeper concern is about physicians and patients making critical health decisions based on diagnostic tests that have generally not been reviewed by the FDA. Without premarket review by the agency, patients, their health care providers, or the FDA itself cannot be assured those tests are accurate and reliable."

Dr. Hamburg said the agency plans to enforce premarket review requirements for higher-risk LDTs, "including those used to determine medical treatment and that have the same intended use of FDA-approved and FDA-cleared companion diagnostics currently on the market."

The agency’s actions received praise from cancer researchers.

"The recent announcements by the FDA are aimed at providing patients and their physicians with an important level of confidence and certainty with regard to the highly complex molecular and genetic information that these diagnostic tests are determining," American Association for Cancer Research President Dr. Carlos L. Arteaga said in a statement. "As an organization that represents the entire continuum of research, from the laboratory to the clinic, including the clinical researchers and physician-scientists engaged in cancer patient care, the AACR looks forward to continuing to engage with the FDA to ensure that the molecular and genetic diagnostic tests that are being utilized by physicians and patients are based on solidly supported scientific evidence."

Many in the health care community, particularly those in the oncology community, are looking at how best to use personalized medicine as a means of achieving better treatment outcomes and controlling costs of health care.

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