December 2008: Volume 34, Number 12
FDA Clears Ikonisys HER2 Test
Ikonisys announced 510(k) clearance for its oncoFISH HER2 test, a fully automated microscopy-based application for determining HER2 status in human breast cancer specimens. Labs process the specimens with Abbott’s PathVysion HER2 DNA Probe kit and run the test on Ikonisys’s automated CellOptics platform that uses a high-throughput digital microscope. Increased quantities of HER2 protein can cause rapid tumor growth, resistance to certain types of treatment, decreased disease-free periods, and short overall survival in breast cancer patients.
Automated HVC Viral Load Test Approved
Roche Molecular Diagnostics announced the FDA approval of its COBAS AmpliPrep/COBAS TaqMan HCV test. The test uses proprietary real-time PCR to quantify the amount of HVC RNA in a patient’s blood. The test offers a broad dynamic range, down to the “undetectable” low levels of viremia, and is calibrated to WHO traceable standards, with a lower detection limit of 18 IU/mL. Designed for use with Roche’s AmpliPrep sample preparation instrument and TaqMan analyzer, the test is the third Roche COBAS TaqMan real-time PCR test approved by FDA in that last 18 months.
FDA Clears Sysmex IG and RET-He Parameters
Sysmex announced the FDA clearance of its Immature Granulocyte (IG) parameter and Reticulocyte Hemoglobin Equivalent (RET-He) parameter for use on the company’s XT-Series automated hematology analyzers. The IG parameter provides a quantitative immature granulocyte count for metamyelocytes, myelocytes, and promyelocytes using the XT-Series instrument’s fluorescent flow cytometry. Identification of immature granulocytes is primarily of importance in diagnosing infectious and inflammatory diseases. The RET-He parameter provides a direct measurement of the mean reticulocyte hemoglobin content, assisting physicians with diagnosing iron deficiency.
Molecular MRSA Test Gets Moderate Complexity Categorization
Cepheid announced that its Xpert MRSA/SA blood culture test has received a moderate complexity categorization from FDA, allowing the test to be performed in a wider range of settings. The test is designed for on-demand detection of MRSA and SA in positive blood cultures. Cleared for marketing in October, the test is the first molecular diagnostic test for positive blood cultures to receive the moderate complexity CLIA categorization. The test runs on Cepheid’s GeneXpert system, a platform designed for detecting healthcare-acquired infections.