Print“Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether, says FDA Commissioner Margaret Hamburg”
The U.S. Food and Drug Administration proposes to more strictly regulate tests used to help physicians diagnose and treat patients to make sure that they provide accurate, consistent, and reliable results. Such tests include laboratory developed tests and gene tests that sequence the entire human genome.
It means that the FDA will review many genetic tests, such as those developed by Myriad Genetics, LabCorp, and others that screen for gene defects to determine the appropriate drug to use for treatment; tests that are currently not reviewed by the agency.
The FDA has notified Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests, or LDTs, which are designed, manufactured, and used within a single laboratory. They 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 LDTs or traditional diagnostics.
“Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether,” says FDA Commissioner Margaret Hamburg. “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 has had the authority to regulate these tests as medical devices since 1976. But at that time LDTs were simple and mostly used to diagnose rare diseases. “Today, many LDTs are more complex, have a nationwide reach and have higher-risk uses such as detection of risk for breast cancer and Alzheimer’s disease,” says Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, in a blog post. These tests sometimes compete with FDA-approved tests without clinical studies to support their use.
“That’s concerning,” Shuren writes. “Without appropriate safeguards, neither patients nor their health care providers can be assured that these tests are safe and effective.”
The agency is also 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 the cornerstone for personalized medicine, helping physicians in selecting appropriate therapies for individual patients based on the genetics or molecular profile of their 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. The guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.
The agency’s LDT notification to Congress outlines details of the draft guidance through which the agency would propose to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, 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 pre-market review for other high risk and moderate risk LDTs over time.
The FDA also said it will continue to exercise enforcement discretion for low-risk LDTs, such as those for rare diseases and, under certain circumstances, tests for which there is no FDA-approved or cleared test.
“With today’s 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,” Shuren says. “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.”
Under FDASIA, the FDA will wait 60 days before publishing draft guidance for public comment and will also hold a public meeting during the comment period to collect additional input.
August 01, 2014
http://www.burrillreport.com/article-fda_to_regulate_gene_tests_that_match_patients_with_therapies.html
