Since September 2006, the FDA has released a series of draft guidances on two issues related to genetic testing. One series addressed the agency’s position on commercially distributed analyte specfic reagents (ASRs) and the role and responsibilities of ASR manufacturers. ASRs are the building blocks of laboratory-developed tests. The other regarded the category of diagnostic tests referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIA). This subgroup includes genetic tests derived from in vitro assays and an algorithm for the purpose of obtaining clinical information that may lead to diagnoses or treatment.