In This Issue...

FDA Announces New Draft Guidance on Molecular Diagnostic Instruments

The Food and Drug Administration (FDA) released new draft guidance, "Molecular Diagnostic Instruments With Combined Functions," which outlines the agency's thinking on regulation of molecular diagnostic instruments including approved or cleared functions as well as functions that do not require approval or clearance. The new guidance applies to instruments used with assays that measure or characterize human or microbial nucleic acid analytes, as well as to software intended for use with these instruments or with approved molecular diagnostic assays.

The guidance also details the information FDA recommends applicants include in a submission for a molecular diagnostic instrument with combined functions. In the past, FDA has handled the permissibility of such instruments on a case-by-case basis, providing informal advice in response to individual inquiries. When finalized, the agency intends that this draft guidance will standardize its approach to these instruments.

FDA is accepting comments on the draft guidance until July 8 online.

FDA Issues Emergency Use Authorization for H7N9 Influenza Screening

With the threat of a deadly outbreak of avian influenza spreading to the U.S., Secretary of Health and Human Services Kathleen Sebelius on April 19 authorized the emergency use of in vitro diagnostics for detection of the avian influenza (H7N9) virus. FDA quickly took action, issuing an Emergency Use Authorization (EUA) on April 22 for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. Laboratories can use this test in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR assays for the presumptive detection of the H7N9 virus in patients with respiratory infection symptoms.

Under the new EUA, the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument from Life Technologies also received clearance for use under the CDC protocol for emergency H7N9 screening. Along with the company's SuperScript III One-Step qRT-PCR reagent kit, laboratories can monitor the spread of the pathogen with the 7500 Fast Dx Real-Time PCR instrument and CDC's Human Influenza Virus Assay.

FDA Clears BD Diagnostics C. difficile Test

BD Diagnostics received FDA clearance for the BD Max Cdiff Assay for detecting the toxin B gene (tcdB), an essential gene in Clostridium difficile infection. Designed for use on the fully-automated BD Max System, the BD Max Cdiff assay is the third FDA-cleared assay on this system. Other assays cleared for the BD Max platform include the BD Max MRSA for the detection of methicillin-resistant Staphylococcus aureus, and BD Max GBS for the detection of Group B Streptococcus.

Luminex Receives FDA Clearance for Multiplexing Instrument

FDA granted clearance to Luminex for its Magpix instrument along with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). Based on Luminex's xMAP Technology, the Magpix instrument is a compact, multiplexing platform that analyzes proteins and nucleic acids in a variety of sample matrices. It can perform up to 50 different tests in a single reaction. In January 2013, the xTAG GPP became the first test cleared in the U.S. that simultaneously detects 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis.