Yesterday, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by healthcare 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, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. 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.
Second, consistent with the requirements of the Food and Drug Administration 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 (LDTs), which are designed, manufactured, and used within a single laboratory. They include some genetic tests and tests that are used by healthcare professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.
“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,” says FDA Commissioner Margaret A. Hamburg, MD. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s 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.”
The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements. Read the full FDA press release.
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