July 2011 Clinical Laboratory News: News from the FDA

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PCR-based Hepatitis C Test Gets Nod

Abbott has received FDA approval to market its RealTime PCR (polymerase chain reaction) test for measuring hepatitis C (HCV) viral load. The Abbott RealTime HCV assay is designed to be used as an aid in managing HCV-infected patients undergoing antiviral therapy, and helps physicians predict sustained and non-sustained virological response to HCV therapy.

Test to Monitor Lung Cancer Cleared

Fujirebio Diagnostics has received FDA clearance to market the first biomarker assay to aid in the management of patients with lung cancer. The CYFRA 21-1™ EIA test monitors disease progression during the course of disease and treatment of lung cancer patients.

Q Fever MDx Test Cleared

FDA has cleared the first nucleic acid amplification test for the diagnosis of Q fever infection in military personnel serving overseas. The test was developed by Idaho Technology and funded by the Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense. The test identifies and detects the bacteria that cause Q fever, Coxiella burnetii, within 4 hours.

Clearance for BioMérieux’s MRSA Test

BioMérieux has received FDA clearance to market its automated molecular test for methicillin-resistant Staphylococcus aureus. The NucliSens EasyQ MRSA test detects seven MRSA types, covering the most prevalent strains.

Siemens Gets Clearance for Heroin Use Screening Test

Siemens Healthcare Diagnostics has received FDA clearance for its newest drugs-of-abuse test, the Emit® II Plus 6-Acetylmorphine assay. The test allows labs to selectively test for heroin use. The Emit II Plus 6-Acetylmorphine assay differentiates heroin from other opioids with no cross-reactivity to structurally related substances and is part of Siemens’ Syva® Emit drugs-of-abuse testing assay menu.

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