Agilent Technologies (Palo Alto, California) has introduced what it calls "the industry's most up-to-date microarray" to provide genome-wide coverage of the zebrafish (Danio rerio), and the first commercial whole mouse genome microarray based on the National Institute on Aging (NIA) Mouse Gene Index. The zebrafish and mouse microarrays were developed in collaboration with Icoria, a member of the Toxicogenomics Consortium, and the NIA, respectively. Agilent said these new designs expand researchers' ability to perform highly detailed genetic research, functional genomics, gene discovery and identification, pathway analysis, and drug discovery and development. Model organisms allow cross-species research that can be applied to humans. Researchers can access the content of these microarrays using Agilent's eArray, a web-based microarray design tool that allows scientists to mine the most up-to-date content of the company's catalog arrays and design custom arrays for their own experiments. The zebrafish is a useful organism in researching gene functions related to vertebrate development and genetics.
CAS Medical Systems (Branford, Connecticut) reported acceptance of an abstract demonstrating initial validation of its cerebral oximeter for presentation at the American Society of Anesthesiologists' (ASA) annual meeting in October. The abstract details the performance of the new CAS monitor on healthy volunteers in a study conducted by Duke University Medical Center (Durham, North Carolina). Data from this study was also presented at the recent Duke Cardiothoracic and Regional Update in Hilton Head Island, South Carolina. The CAS cerebral oximeter uses the company's Near Infra-Red Spectroscopy technology, a non-invasive, optically based technique, to monitor brain oxygenation continuously by determining absolute cerebral tissue oxygen saturation. In combination with pulse oximetry, the CAS monitor may be used to estimate the cerebral venous oxygen saturation. Results from the study show that the CAS cerebral oximeter shows a high level of accuracy and consistency when compared to reference co-oximetry measurements. The data from this study has been submitted to the FDA as part of the company's 510(k) premarket notification.
Envisioneering Medical Technologies (St. Louis), a manufacturer of diagnostic and treatment technology, said a recent study confirms that TargetScan, a new FDA-approved targeted prostate biopsy and cancer treatment system, delivers improved biopsies for the detection and treatment of prostate cancer. According to the study performed at Washington University (St. Louis), TargetScan's application of a stationary probe with 3-D image acquisition provided better biopsy information about the location, extent and aggressiveness of prostate cancer compared to conventional biopsy techniques. For patients, these findings mean that a TargetScan biopsy may lead to improved cancer detection and more accurate prognoses, the company said. The clinical test showed that TargetScan detected cancer more frequently upon the first biopsy than over conventional biopsy techniques. Additionally, the researchers suggested that TargetScan's stabilized probe coupled with its ability to reproduce biopsies and intraprostatic needle localization could improve the success of new cancer-treatment deliveries, such as brachytherapy and cryotherapy.
Instrumentation Laboratory (Lexington, Massachusetts), a manufacturer of in vitro diagnostic instruments, related reagents and controls, reported that it has received FDA 510(k) clearance for its HemosIL D-Dimer HS assay. This new-generation rapid, automated, latex-enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP Hemostasis Testing System, aids in the diagnosis of venous thromboembolism (VTE). HemosIL D-Dimer HS delivers results in less than five minutes, and offers ease of use, enhanced analytical sensitivity and working range, and minimized interferences from rheumatoid factor and hemoglobin.
Meridian Bioscience (Cincinnati) reported that Viral Antigens (VIA; Memphis, Tennessee), its wholly owned subsidiary and supplier of purified virus proteins, received a patent titled "Specificity in the detection of anti-rubella IgM antibodies" from the U.S. Patent and Trademark Office. U.S. patent No. 6,872,396 encompasses improved methods for detection of anti-rubella IgM antibodies in commercial diagnostic products, used to test blood samples for the presence of rubella antibodies. The company said that diagnostic tests using VAI's new technology for detection of anti-rubella IgM antibodies would reduce the number of false-positive test results.
Roche Diagnostics (Indianapolis) reported that it has received FDA clearance for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker tests. The Elecsys PreciControl Tumor Marker control adds to Roche Diagnostics' growing tumor marker portfolio that includes prostate-specific antigen; free prostate-specific antigen; Alpha-fetoprotein; carcinoembryonic antigen, CA-15-3, which monitors treatment of breast cancer and recurrences; and CA-125, which monitors the treatment of ovarian cancer. Because one control can be used with all of the tests, laboratory professionals could see an increase in efficiency and productivity — there is no need to switch controls in order to run different tests. Roche Diagnostics has filed a submission with the FDA for its Elecsys CA 19-9 assay, and that submission is pending.