American Association for Clinical Chemistry
Better health through laboratory medicine
April 2011 Clinical Laboratory News: News from the FDA

News from the FDA

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OraSure, Roche Receive Clearance for First Automated, Oral DOA Assays

FDA has granted OraSure Technologies, Inc. and Roche 510(k) clearance on four homogeneous, fully automated, drug-of-abuse assays for use exclusively as part of OraSure’s Intercept oral-fluid drug test. The cleared assays—phencyclidine, cocaine, opiates, and methamphetamine—use Roche’s kinetic interaction of micro-particles in solution (KIMS) technology and run on clinical chemistry automated analyzers, allowing oral fluid samples to be processed for the first time with the same efficiency as fully automated, urine-based drug tests. The companies plan to make these four tests available for sale later this year.

Meridian Bioscience’s C. difficile Test Cleared for Pediatric Use

Meridian Bioscience has received FDA clearance for its illumigene C. difficile (Clostridium difficile) molecular amplification test for pediatric patients. The test targets the region of the C. difficile DNA that is present in all toxin A and/or toxin B producing strains. Based on Meridian’s loop amplification technology, the test generates results in less than 1 hour.

Everolimus Immunoassay Cleared for Kidney Transplants Patients

FDA has cleared the QMS Everolimus Immunoassay from Thermo Fisher Scientific. Designed to help manage potential organ rejection in kidney transplant patients, the new assay measures the blood level of everolimus, an immunosuppressant that helps prevent organ rejection in kidney transplant patients. It is the first cleared by FDA for this purpose.

MammaPrint Gets Another Green Light

Agendia has received another clearance for its MammaPrint breast cancer recurrence assay, the first in vitro diagnostic multivariate index assay approved by the FDA in early 2007. In the new clearance, FDA now will allow Agendia to run the test on two additional Agilent microarray scanners and two Agilent Bioanalyzers, expanding the company’s capacity to process test specimens. Previously, only Agendia performed the MammaPrint test in its Irvine, Calif. laboratory. However, the new clearance enables the test to be run in a central laboratory, according to the company’s press release. 

OraSure’s HCV Rapid, POC Test Approved

FDA has approved OraSure Technologies’ OraQuick HCV Rapid Antibody test used to detect hepatitis C virus (HCV) antibodies from a fingerstick, whole-blood sample. The OraQuick HCV Rapid Antibody test is the only rapid, point-of-care test that detects antibodies to HCV. The test runs on the OraQuick technology platform and generates results in 20 minutes.

First Test for Norovirus Outbreaks Gets Nod

FDA has permitted marketing of the first test for the preliminary identification of norovirus, the leading cause of food-borne disease outbreaks in the U.S.

The Ridascreen Norovirus Third Generation EIA assay was developed by the Germany-based R-Biopharm Group as an aid to identify norovirus outbreaks in close-contact, group settings. The test is not sensitive enough for diagnosis of a single symptomatic person, but can be used when a number of people have simultaneously contracted gastroenteritis and there is a clear path for virus transmission, such as a shared location or food.

Wako Diagnostics Gets Clearance for Microfluidic-based Test System

FDA granted 510(k) clearance to the uTASWako i30 Immununoanalyzer along with two tests to assess the risk of liver cancer, alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP). The new analyzer uses microfluidic technology along with immunochemical and electrophoretic techniques to produce rapid results. The instrument’s two assays are intended to aid in the assessment of patients with chronic liver disease who are at risk of hepatocellular carcinoma.