NEW YORK (GenomeWeb News) - The US Food & Drug Administration has released a draft regulatory guidance for industry and clinical labs for in vitro diagnostic multivariate index assays, the agency said today.
IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making, the agency said.
The guidance outlines the agency’s regulatory approach to IVDMIAs to assure the public that these tests are safe and effective. The draft guidance is intended for public comment and does not establish legally enforceable responsibilities at this time.
The draft defines IVDMIAs and outlines the regulatory rules for companies and labs that manufacture them.
IVDMIAs employ an algorithm to evaluate patient test results, including protein and genetic data, along with other clinical information for diagnosis and treatment for diseases such as breast cancer, prostate cancer recurrence, cardiovascular disease, and Alzheimer's disease.
The FDA is accepting public comment on the draft guidance for 90 days. Comments may be submitted here.