Alberto Gutierrez, PhD
"In Vitro Diagnostic Multivariate Index Assays"
In September 2006, the Food and Drug Administration (FDA) released a draft guidance outlining how the agency intends to regulate in vitro diagnostics utilizing multivariate index analyses (IVDMIAs). These new, highly complex tests are increasingly being used to diagnose, treat and manage a variety of diseases and conditions, including breast and prostate cancer, as well as cardiovascular disease.
The draft guidance has led to much discussion within the laboratory community about which in-house developed tests are subject to FDA oversight and which are not. This Expert Access session is intended not only to give laboratorians and other medical professionals a chance to ask an FDA representative about the agency’s thinking on IVDMIAs, it also offers the FDA an opportunity to gain a greater understanding of concerns from the clinical laboratory.