FDA Considers New Type of Medical Test

The U.S. Food and Drug Administration Wednesday issued draft regulatory guidelines for a new type of medical test.

The FDA said the test uses complex mathematical formulas to interpret large amounts of gene and protein data to produce results that can help guide medical decision-making.

The test — known as In Vitro Diagnostic Multivariate Index Assays, or IVDMIAs — includes some of the most promising developments in diagnostic testing to date, FDA officials said. The guidance is intended to clarify the agency’s regulatory approach to IVDMIAs to assure the public the tests are safe and effective.

More and more of these kinds of medical tests are being made available each year, said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. It is important for the companies and labs making the tests to clearly understand the regulatory requirements in place so that the tests they develop are as safe and effective as possible.

The FDA said IVDMIAs employ an algorithm to evaluate patient test results along with other clinical information for use in the diagnosis of such diseases and conditions as breast cancer, prostate cancer recurrence, cardiovascular disease, and Alzheimer’s disease.