Draft Guidance for Industry and Food and Drug Administration Staff, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.

The Food and Drug Administration (FDA) is issuing this draft guidance to provide industry and agency staff members with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid based diagnostic devices (hereafter referred to as HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.

For the purposes of this draft guidance document, the multiplex level that is used to define HMMDs is the capability to detect greater than or equal to 20 different organisms/targets, in a single reaction, using a nucleic acid-based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection, and result interpretation.

HMMDs are used to aid in the diagnosis of infection.

[Source: FDA]