April 2008 Clinical Laboratory News: News from the FDA

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April 2008: Volume 34, Number 4

Siemens Gets Green Light for Molecular Viral Load Analyzer

Siemens Healthcare announced the FDA clearance of its VERSANT 440 Molecular System, an instrument that runs the VERSANT HCV RNA 3.0 viral load assay. The instrument performs branched DNA (bDNA) analysis and is designed for walk-away automation. It integrates bar code data entry, automated reagent processing, signal amplification detection, and a LIS interface for downloading patient work lists and results.

FDA Clears Diazyme Cystatin C Assay

Diazyme announced the FDA clearance of its Cystatin C assay kit for the quantitative determination of cystatin C in serum and plasma samples. The method is a liquid-table, two reagent immunoturbidmetric system that can be applied to most common clinical chemistry instrumentation. The assay has a reportable range of 0.47 mg/L to more than 8 mg/L, reducing the need for re-testing elevated samples. 

FDA Clears CellSearch Test for Metastatic Prostate Cancer

Veridex, LLC announced the FDA decision to clear its CellSearch System to be used as an aid in the monitoring of metastatic prostate cancer. The CellSearch System was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer. In November 2007, the test was cleared as an aid in monitoring colorectal cancer.

To validate the new clearance for metastatic prostate cancer, a multi-center trial involving 65 clinical centers looked at 231 metastatic prostate cancer patients about to enter first-line or later-line chemotherapy. The data showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and PSA assessment can offer a more accurate assessment of prognosis, Veridex said.

Automated PLAC Test Cleared

diaDexus announced FDA clearance of a new automated version of its PLAC test. Based on immunoturbidimetric technology, the immunoassay is designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche, and Olympus. The PLAC test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme that is specific to vascular inflammation related to rupture-prone plaques. 

QuickVue RSV Test Gets CLIA Waiver

Quidel announced that the FDA granted a CLIA waiver for its QuickVue RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver will make the test more widely available for use in physician offices and clinics that use waived tests. Intended as an aid in the rapid diagnosis of acute RSV viral infections, the test received its original 510(k) clearance in September of 2006. The test allows for the rapid, qualitative detection of RSV directly from nasopharyngeal swab and nasopharyngeal aspirate specimens from symptomatic patients 18 years of age and younger.

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