• Abbott Laboratories (Abbott Park, Illinois) said that it received FDA approval for its automated HTLV-I/HTLV-II blood screening test for use on the Abbott Prism instrument. The test is intended for use by laboratories to screen individual donations of blood and plasma for antibodies to human T — lymphotropic virus Type I and/or human T — lymphotropic virus Type II (anti-HTLV-I/HTLV-II). HTLV-I and HTLV-II are closely related but distinct retroviruses associated with several diseases including human T-cell leukemia and neurological disorders, according to the Centers for Disease Control. The Prism instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The Prism system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift. Abbott Diagnostics makes in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

• Aperio Technologies (Vista, California) received FDA clearance for the manual read of digital HER2 slides from a computer monitor using its patented ScanScope digital slide scanning system. The system is intended for use as an accessory to the Dako HercepTest to aid pathologists in the detection and semi-quantitative measurement of HER2 protein expression to assess breast cancer patients for whom Herceptin treatment is being considered. The FDA clearance encompasses the company’s complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, and the Spectrum digital pathology information management system for managing, viewing, and analyzing digital slides. Aperio makes digital pathology for the healthcare and life sciences industries.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported the availability of an ultra high-density microarray, Affymetrix based technology (Whole-Genome Sampling Analysis). The offering adds to LabCorp’s products in the clinical genetics laboratory diagnostics sector. LabCorp says that in 2005 it was first to offer the comparative genomic hybridization- (CGH) based microarray diagnostics which focused on mental retardation and developmental delay. This targeted testing underscored the need for higher density whole genome coverage. The Affymetrix-based technology provides analysis of DNA copy number changes – identifying deletions, gene amplifications and loss of heterozygosity (LOH). LabCorp makes diagnostic technologies.

• A new creatinine monitoring system from Nova Biomedical (Waltham, Massachusetts) enables simple, rapid, and accurate assessment of renal function by finger prick capillary blood sampling at the point of care (POC), according to the company. Incorporating new patented, Multi-Well test strip technology adapted from Nova’s hospital glucose monitoring system, Nova StatSensor Creatinine allows creatinine to be measured with a simple 30 second test in the emergency department, radiology, oncology, or other POC areas where renal function must be assessed. StatSensor Creatinine measures creatinine and calculates estimated glomerular filtration rate (eGFR) by MDRD or Cockroft-Gault equations. Creatinine with eGFR is a more accurate and sensitive measurement of kidney function than creatinine alone. StatSensor Creatinine interfaces with hospital and laboratory information systems. Nova makes blood gas/electrolyte analyzers in hospitals, and chemistry analyzers for cell culture and fermentation in biotechnology.

• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for its EnSite Fusion Registration Module, software designed to help physicians create detailed heart models to facilitate diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including atrial fibrillation. EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy to better guide the delivery of therapy. EnSite Fusion has the capability for “dynamic registration,” which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3D, CT model.