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

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Conjunctivitis Test Gets Nod

Rapid Pathogen Screening Inc. has received FDA clearance for its rapid, point-of-care test to diagnose adenoviral conjunctivitis. The RPS Adeno Detector Plus test is designed to detect all known serotypes of adenoviral conjunctivitis in 10 minutes, using a small sample of human tears.

SQI Diagnostics Platform, Test for Celiac Disease Cleared

FDA has given SQI Diagnostics Inc. clearance to market its SQIDworks platform and IgXPlex celiac qualitative assay. The 4-plex microarray-based assay detects anti-tissue transglutaminase IgG and IgA and is the second multiplexed assay to obtain FDA clearance to operate on the SQIDworks platform.

U.S. Army Test for Diagnosing Leishmaniasis Gets Green Light

The SMART Leish PCR assay, which uses polymerase chain reaction to help detect cutaneous leishmaniasis, has received FDA clearance. The test is intended to help in the diagnosis of people with cutaneous leishmaniasis caused by certain species of sand flies. The SMART Leish PCR assay was developed in partnership by the Walter Reed Army Institute of Research, Army Medical Materiel Development Activity, and Cepheid USA, Inc.

Test to Determine HER2 Gene Status In Breast Cancer Patients Approved

FDA has approved the first fully automated assay designed to aid in determining if women with breast cancer are HER2-positive and therefore candidates for trastuzumab (Herceptin), a commonly used breast cancer treatment. The Inform Dual ISH test, manufactured by Ventana Medical Systems, allows for measurement of the number of copies of the HER2 gene in tumor tissue.

Nanosphere’s PMA for Metabolism Test Denied

Nanosphere has received a not approvable letter from the FDA for its Verigene Clopidogrel Metabolism Nucleic Acid Test. The molecular diagnostics firm filed a premarket approval application for its test intended to assess whether a patient is successfully metabolizing the anti-platelet drug Plavix (clopidogrel). According to Nanosphere, the deficiencies cited in the letter are resolvable, and it believes the test will ultimately receive clearance from the agency.