The Food and Drug Administration (FDA) said recently that it plans to begin regulating certain diagnostic tests developed by laboratories, which have grown more sophisticated in recent years, spurring concerns about their safety and reliability. Just as new drugs must be proved safe and effective before reaching consumers, the devices used to diagnose complex medical conditions also must work properly to avoid harmful or unnecessary treatments.
First, the FDA is issuing a guidance on the development, review, and approval 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, the agency is notifying Congress of its intention to publish an oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. These include some genetic tests and tests that are used by health care professionals to guide medical treatment for their patients.
The companion diagnostics guidance is intended to help companies identify the need for the 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 work together earlier than before which will result in faster access to 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 This guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.
For years, the FDA had chosen not to actively regulate laboratory-developed tests, or LDTs, because they tended to be simple devices used to diagnose rare or œlow-risk diseases. In recent years, however, the tests have become more widely used and more specialized, able to diagnose specific forms of cancer and other diseases with complex genetic data. Government regulators say the evolution makes it more critical than ever to ensure that the tests are safe and trustworthy and that patients who rely on them aren’t misdiagnosed. Several incidents in recent years have underscored those concerns, including instances in which the reliability of LDTs for cervical cancer, Lyme disease and whooping cough have been questioned.
The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they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.
Making sure that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions should be a top priority.
To read the FDA announcement, click here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407321.htm