Ki-67 Prostate Image Analysis Algorithm
Part of the Virtuoso software suite
BioImagene, Cupertino, Calif, launches a new Ki-67 prostate image analysis algorithm. The algorithm, part of the company’s Virtuoso™ suite of Web-based software applications for digital pathology, is used to detect and provide quantitative measurement of the protein biomarker Ki-67. According to several published studies, Ki-67 immunohistochemistry may be a valuable predictor of biochemical relapse and distant metastasis after prostatectomy and radiation therapy. The company also has a PIN4 algorithm for prostate cancer research and FDA-cleared algorithms for assessment of HER2/neu immunohistochemistry status.
CLINITEK AUWi System
Two urine analyzers in one
Siemens Healthcare, Deerfield Ill, now offers its CLINITEK® AUWi system, a combination of both the CLINITEK Atlas® automated urine chemistry analyzer and the Sysmex UF-1000i™ urine cell analyzer. The new system streamlines workflow by automatically transporting samples from one workstation to another, allowing lab personnel more than 1 hour of walk-away time. The system automatically manages samples requiring sediment analysis and auto-verifies results to be reported to the Laboratory Information System. Each CLINITEK AUWi System comes equipped with new WAM software that allows the user control over the testing process.
Cervista HPV Tests
Includes HPV high-risk and HPV 16/18 tests
Hologic Inc, Bedford, Mass, has received FDA premarket approval for both the Cervista™ HPV high risk (HR) and the Cervista HPV 16/18 tests. Cervista HPV HR is designed to detect the 14 high-risk types of HPV known to cause cervical cancer and has been approved to screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. Cervista HPV 16/18 genotypes HPV types 16 and 18 and is approved to be used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results to assess the presence or absence of specific high-risk HPV types. Both tests have been approved to be used adjunctively with other testing to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
Stabilization of rWBCs
Streck Inc, Omaha, Neb, has added Leuko Preserve™ to the company’s line of cell stabilization products. Leuko was developed specifically for the stabilization of residual white blood cells (rWBCs) in leukoreduced red blood cell samples. Leuko Preserve is compatible with commercially available kits intended for detection and enumeration of rWBCs by flow cytometric analysis. It is able to stabilize residual white blood cells for up to 7 days following leukoreduction, extending the time frame for enumeration. Sample backlogs, instrument problems, and shipping delays are no longer an issue.
Gentian Cystatin C Immunoassay
For diagnosis and treatment of renal disease
Beckman Coulter Inc, Fullerton, Calif, has added Gentian Cystatin C Immunoassay (CYSX) to its renal menu. The assay is used for the quantitative determination of cystatin C in human serum and plasma; when used on the company’s Synchron® and UniCel® Clinical Systems, the Gentian Cystatin C Immunoassay is used in the diagnosis and treatment of renal disease. Reagents and calibrators for the Gentian Cystatin C assay are liquid and ready to use, eliminating the need for mixing, hydrating, or prediluting reagents before testing.