FDA Takes Steps to Ensure Reliability of Some Cancer Tests

The United States Food and Drug Administration (FDA) has announced that it will become involved in the process of ensuring reliability, accuracy and consistency with some tests used to diagnose and treat cancer.

The FDA provides its stamp of approval for tests that are sold directly to consumers prior to their legal sales. However, the FDA did not previously hold this authority when it came to tests sold directly to healthcare providers, as this task was left to other government agencies.

Since the role of testing is become more mainstream in oncology, particularly as molecular and genetic testing on an individual level often drives treatment decisions among patients with cancer, the FDA will now proceed with the role of ensuring the tests’ reliability, accuracy and consistency.

In a recent press release, the FDA stated the following:

“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 health care professionals to guidemedical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.”

Reference: United States Food and Drug Administration. FDA News Release: FDA takes steps to ensure the reliability of certain diagnostic tests. Available at: Accessed August 1, 2014.