In This Issue...

FDA Releases Draft Guidance Clarifying Good Laboratory Practice Regulations

The Food and Drug Administration (FDA) has announced the availability of the draft guidance, "The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers." The agency issued the good laboratory practice (GLP) regulations to address concerns that poor research practices and laboratory misconduct had undermined the reliability of several important studies supporting the safety of FDA-regulated products. This draft guidance responds to frequently asked questions about the applicability of GLP to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices. It also clarifies GLP terminology and, if applicable, the types of information related to GLP that should be provided to FDA. When finalized, it will represent FDA's current thinking on GLP.

The agency is accepting comments on this draft guidance until November 26. Electronic comments may be submitted online.

Magellan Receives Clearance for Lead Blood Test

FDA has cleared Magellan Diagnostic, Inc.'s LeadCare Ultra Blood Lead Testing System for quantifying lead levels in blood. According to Magellan's press release, LeadCare Ultra is the first plug-and-play, bench-top system for laboratory lead analysis. It is based on technology developed by Magellan that has been in use for nearly two decades.

FDA Approves Alere Test for Early HIV Detection

Alere Inc. has received FDA approval for the Alere Determine HIV 1/2 Ag/Ab Combo for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2. The new test, which is classified as a moderately complex medical device under CLIA, is the first and only FDA-approved, rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen. The HIV-1 p24 antigen can appear days after infection and prior to HIV-1/2 antibodies, allowing healthcare workers to detect HIV in patients earlier than with second- and third-generation antibody-only tests.

FDA Clears Spartan Bioscience Drug Metabolism Test

Spartan Bioscience received FDA clearance for the Spartan RX CYP2C19 System, which provides genetic results in less than 60 minutes from a non-invasive cheek swab. This automated sample-to-result system identifies CYP2C19*2, *3, and *17 variations, providing clinicians with information that helps determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. The CYP2C19 enzyme metabolizes approximately 15% of all prescribed drugs.

Cepheid Tuberculosis Test Categorized as Moderate Complexity Under CLIA

FDA has categorized Cepheid's Xpert MTB/RIF test as moderate complexity under CLIA, making it the first and only molecular tuberculosis (TB) test to receive this rating. Designed for Cepheid's GeneXpert Systems, the Xpert MTB/RIF test detects Mycobacterium tuberculosis complex (MTB-complex) DNA in approximately 2 hours, as well as rifampin-resistance associated mutations of the rpoB gene. This latter capability can not only help clinicians identify patients with rifampin-resistant TB strains, but it can also indicate strains that may be multidrug-resistant.

bioMérieux Receives FDA Nod for Rapid Microbial Identification Technology

FDA granted bioMérieux 510(k) clearance for VITEK MS, a clinical mass spectrometry MALDI-TOF-based system for the rapid identification of disease-causing bacteria and yeast. The VITEK MS can detect nearly 200 different microorganisms that represent the majority of bacterial and fungal infections that afflict humans, yielding results in minutes. Its overall accuracy is 93.6% when compared to the accuracy of 16S Ribosomal RNA gene sequencing, the gold standard for identifying anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae, and yeast.

BD Gets FDA Clearance for Trichomoniasis Assay 

FDA has cleared BD Diagnostics' BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay for the diagnosis of trichomoniasis on the BD Viper System with XTR Technology. This platform performs direct qualitative detection of T. vaginalis DNA in endocervical and vaginal samples, as well as neat urine specimens. It offers automated DNA extraction and simultaneous amplification and detection, improving accuracy and time to results compared to wet mount microscopy and culture, according to BD. The BD Viper System also allows laboratories to test samples in panel mode for T. vaginalis, C. trachomatis, and N. gonorrhea, or in batch mode for chlamydia and gonorrhea, trichomonas, and herpes on the same automated platform.