Abbott (Abbott Park, Illinois) said the FDA has approved its UroVysion DNA probe assay for use as an aid in the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer. The company said that with this approval, UroVysion is the first gene-based test available for both diagnosis and monitoring of bladder cancer recurrence. The test is designed to detect genetic changes in bladder cells in urine specimens using fluorescence in situ hybridization, or FISH. "UroVysion is significantly more sensitive than conventional methods for the detection of bladder cancer," said Michael Sarosdy, MD, a urologic oncologist and lead investigator of the UroVysion study. "This new use should allow physicians to make an earlier diagnosis, with earlier treatment."
Biotronik (Lake Oswego, Oregon) reported the first worldwide implantation of a Philos II DR-T pacemaker and a Lexos DR-T ICD with Home Monitoring Early Detection technology. The advanced Home Monitoring technology integrates wireless, cellular phone and standard phone technology for what the company called "unsurpassed" mobility and coverage. The cardiac devices allow physicians to remotely and automatically monitor their heart patients anytime, anywhere. The implantations were performed at the Yakima Heart Center (Yakima, Washington) and Parkwest Medical Center (Knoxville, Tennessee).
Chembio Diagnostics (Medford, New York) reported that it has launched its third HIV rapid test, HIV Stat-Pak Dipstick, to complete its suite of rapid HIV tests for use in HIV testing programs in international settings. HIV Stat-Pak Dipstick is the most cost-effective of the three; the product will be sold to international relief programs for around $1 per test. HIV Stat-Pak Dipstick is based upon the same test strip as Chembio's other HIV rapid tests but does not have the plastic housings they use to facilitate sample collection and other features, which reduces material, labor and shipping costs.
GE Healthcare (Waukesha, Wisconsin) has unveiled new cardiac imaging techniques developed with the world's first high-definition magnetic resonance (HDMR) system. The applications were launched at the Society for Cardiovascular Magnetic Resonance's scientific sessions in San Francisco. HDMR provides physicians with what GE called "unprecedented image clarity" of patients who are difficult to image due to movement. The GE imaging techniques introduced at the meeting include 1.5 Tesla Excite HD MR Echo Cardiac Imaging, real-time imaging of the heart with the resolution of MR at the speed of ultrasound, without the need for breath-holding or ECG gating. The company said its MR Echo produces high-definition cardiac images in real time of the sickest of patients, providing clinicians with the contrast detail of MR with the real-time speed and ease of use of echocardiography. Also introduced was Excite HD TRICKS (Time-Resolved Imaging of Contrast KineticS) angiographic imaging, with a new 32-element peripheral 1.5 Tesla vascular coil providing images of the lower leg and foot vessels with what GE called "unprecedented definition." The company said TRICKS accelerates the temporal resolution of 3-D dynamic imaging, with clinicians able to acquire 12 times the amount of data typically collected in a conventional MR angiography exam. The company also is showing its ReportCARD tool, which it said "significantly reduces review, analysis and cardiac MR reporting time."
iCAD (Nashua, New Hampshire) reported the release of its Second Look 700 Computer Aided Detection (CAD) solution. The Second Look 700 addresses the needs of film-based breast care providers with higher patient volumes and existing or planned digital information and medical imaging systems. The system operates effectively on a stand-alone basis or as an integrated component of the medical enterprise's digital workflow. The Second Look 700 has a modular design, allowing users to acquire the basic, small-footprint, low-profile early breast cancer detection workstation and to add software upgrades that support communication in the DICOM format for medical images, allow communication with HL-7 standard hospital information systems, and to work in conjunction with other mammography information systems. An advantage of the Second Look 700 is the availability of DICOM work list management, which reduces typing and manual data entry, and the related potential for errors, in a radiology information system/picture archiving environment. The Second Look 700 can detect up to 72% of actionable missed cancers, iCAD said, and is offered with multiple operating points that permit the radiologist to manage the systems marking logic and cancer detection sensitivity. The company said the Second Look 700 is the only multi-modality CAD system available today, with an upgrade available to add breast MRI CAD processing and display to the iCAD workstation.
Medline Industries (Mundelein, Illinois) reported the launch of a new sleep apnea at-home prescreening test, SleepStrip. The company said the FDA-cleared test will allow physicians to expedite diagnosis and treatment for patients suffering from obstructive sleep apnea (OSA). SleepStrip is applied by the patient at home just before going to sleep. During the patient's normal sleep pattern, the electro-chemical and microprocessor controlled technology measures fluctuations in airflow. After no less than five hours of sleep, a mathematical algorithm converts these airflow measurements into a quantitative output when the strip is removed. This provides the physician with an indication of whether the patient may have OSA and how severe it may be. SleepStrip is manufactured by SLP Ltd. (Tel-Aviv, Israel).
Nanosphere (Northbrook, Illinois) reported the benefits of its technology for the medical analysis of human DNA. Nanosphere's nanoparticle-based technology allows for rapid, highly sensitive and specific single nucleotide polymorphism (SNP) genotyping. The technology, reported in the February issue of Nucleic Acids Research, allows detection of a SNP in an unknown genotype with a greater than 99% confidence threshold and can be used with human DNA obtained from samples as small as a drop of blood. The technology eliminates the need for costly, time and labor-intensive gene amplification or enzymatic interventions.
Xenogen (Alameda, California) reported that the U.S. Patent and Trademark Office has allowed claims in five patent applications that further protect its methods of real time, non-invasive in vivo optical imaging (biophotonic imaging) of whole animals. Two of the allowed patent applications disclose non-invasive methods for detecting gene expression within a living mammal, where that mammal includes a gene encoding either a bioluminescent or fluorescent reporter protein linked to a selected promoter that drives its expression. The patent claims cover gene promoters that are always "on" or promoters that can be switched on and off. The other three allowed patent applications disclose non-invasive methods for detecting eukaryotic cells or microorganisms in a living mammal, where the cells or microorganisms have been transformed to incorporate either a bioluminescent or fluorescent reporter gene. By monitoring and tracking the resulting light emission from either a bioluminescent or fluorescent reporter, researchers can monitor the growth, spread and eradication of the cells and microorganisms.