February 2010 Clinical Laboratory News: News from the FDA

CLN Banner Logo

February 2010: Volume 36, Number 2

Cepheid Receives H1N1 EUA for CLIA Moderate Complexity Labs

Cepheid announced that it received FDA emergency use authorization (EUA) for its Xpert Flu A Panel test for the diagnosis of the 2009 H1N1 influenza virus. The test runs on Cepheid’s GeneXpert System and is able to identify the virus in less than 1 hour. The test is the first H1N1 assay to receive an EAU that allows moderate complexity labs under CLIA to perform the test, thereby enabling in-hospital testing close to patient care sites. FDA’s EUA will remain in place until April 26, unless the agency terminates it sooner or extends it.

AdvanDx Receives Clearance for Blood Pathogen Assays

AdvanDx received FDA 510(k) clearance for a 90-minute protocol for its Staphylococcus aureus PNA FISH and Staphylococcus aureus/CNS PNA FISH tests. The faster protocol reduces the turnaround time from 2.5 hours to 90 minutes by reducing the PNA probe hybridization from 90 to 30 minutes. The tests are distributed by bioMérieux in the U.S.

EUA Granted for New H1N1 Test

FDA granted emergency use authorization (EUA) to DxNA for the GeneSTAT 2009 A/H1N1 Influenza Test for use in the detection of the 2009 H1N1 influenza virus. The test is a reverse-transcriptase PCR assay designed for use in combination with the Roche High Pure RNA Isolation Kit and the GeneSTAT Analytical Platform. The GeneSTAT Platform allows for point-of-care testing and can determine infection status from a cheek or nasal swab in about 50 minutes.

FDA Expands Clearance for Agendia’s MammaPrint

Agendia announced an expanded FDA clearance for its MammaPrint breast cancer recurrence test. The new clearance permits the use of the test on women of all ages. The first and only FDA-cleared breast cancer recurrence test available to patients and physicians, MammaPrint has received four additional FDA clearances over the past 3 years that expand the indications for use of the test. All MammaPrint tests are conducted in Agendia’s CLIA-accredited service laboratory.

BD STD Assays Cleared

BD Diagnostics, a segment of BD, announced that it received FDA clearance for its ProbeTec Chlamydia trachomatis Qx and BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assays. The tests use samples collected from routine, liquid-based Pap testing and run on the BD Viper System with XTR Technology. The ProbeTec Qx Amplified DNA Assays are the first to receive FDA clearance for gynecological specimens collected and transported in the two leading types of liquid-based cytology preservative media currently in use.

Page Access: