• American Bio Medica (Kinderhook, New York) said that it has launched, and has begun shipping, another new point-of-collection drug test, the Rapid TOX Cup; an all-inclusive drug testing cup. The cup doesn’t require any manipulation of the device; the donor simply voids into the cup. Its wide mouth and larger cup allow for easier specimen collection. A temperature strip is affixed to the cup to ensure specimen integrity, with the option to add a specimen validity test strip. Results obtained with the Rapid TOX Cup can also be photocopied for record keeping purposes. American Bio Medica makes immunoassay diagnostic test kits.
• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported that it now offers integrated screening and sequential screening tests under license from Intema Limited. When integrated screening and sequential screening test results include a fetal ultrasound nuchal translucency measurement, the highest Down syndrome detection rates are achieved and fewer false positives are experienced than with current first- or second-trimester screening. LabCorp specializes in prenatal clinical laboratory testing.
• Nanosphere (Northbrook, Illinois) reported FDA clearance for the Verigene F5/F2/MTHFR nucleic acid test, which detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12). The Verigene is a test for the identification of mutations in three specific genes that together can increase an individual’s risk for dangerous blood clots and their leading complication, stroke. Nanosphere is a nanotechnology-based molecular diagnostics company.
• Roche Diagnostics (Indianapolis, Indiana) says that its CoaguChek XS Plus system offers built-in controls and optional, external liquid controls to help non-waived clinics monitoring anticoagulation ensure accurate PT/INR (clotting time) test results for patients taking blood thinner medication. The handheld, battery-powered CoaguChek XS Plus system has the ability to store up to 500 patient and or liquid quality control results that can be searched by patient, date and time. The meter also is designed for data management connectivity with patient ID, operator lockout and quality control lockouts. The system performs two levels of onboard quality controls as part of every PT/INR test, all in a single test chamber, a feature designed to save time and provide enhanced confidence in the quality of results. The CoaguChek PT test strip also neutralizes therapeutic levels of heparin and low-molecular-weight heparin, enabling physicians to do point-of-care testing on a broad range of anticoagulated patients. Roche’s diagnostics division supplies a wide array of testing products and services to researchers, physicians, patients, hospitals and laboratories.
• Royal Philips Electronics (Andover, Massachusetts) reported North American availability of the next release of Philips Xcelera, a multi-modality image management, physician reporting and information distribution system. Philips’ enhanced Xcelera solution organizes and provides access to images and data from key cardiology subspecialties, including echocardiography, cardiovascular ultrasound, nuclear cardiology, cardiac CT, cardiac MR, cardiac catheterization, and electrophysiology, as well as direct links to ECG studies. The Xcelera solution facilitates the process of documenting the patient’s medical condition, as derived from these clinical tests, into a secure, centralized electronic system. As the patient moves through the care continuum, Xcelera manages and distributes the diverse test results.
• SonoSite (Bothell, Washington), reported the introduction of the S-Cath visualization tool, a specialized ultrasound device designed to meet the specific point-of-care imaging and procedural guidance needs of interventional radiologists and cardiologists. Its available suite of curved, linear and phased array transducers cover a range of guidance for interventional procedures such as line placement, biopsy, dialysis access, stent placement, femoral and other vascular access and fluid drainage as well as abdominal and cardiovascular imaging applications. With standard VESA compliant mounting capabilities, the system offers a zero footprint option for crowded interventionalist suites and cath labs. It can be mounted adjacent to other imaging modalities and moved in and out of the physician’s line of sight as needed. SonoSite makes hand-carried ultrasound devices.