Biomoda (Albuquerque, New Mexico), a developer of cancer diagnostics, said it has completed the first clinical validation of CyPath, its development-stage assay for cancer. These results indicate CyPath's ability to differentiate lung cancer patients, heavy smokers and normal individuals. The cytology assay differentiates normal cells from abnormal cells, with the potential for identifying people with lung cancer and those at risk for developing lung cancer, the company said. CyPath is a product developed from technology licensed from the University of California and from Biomoda's own technology. The company said additional R&D is focused on addressing bladder and cervical cancers, and is currently collecting new samples to further validate the predictability of the assay for early detection of cancer.
Criticare Systems (Milwaukee) reported the introduction of the Veris MRI monitoring system, a joint development effort with Medrad (Indianola, Pennsylvania). This program began in 2003 as a multi-year agreement with the goal of developing an advanced monitoring system specific to MRI applications. Veris is the first MR monitor with five-lead ECG waveform monitoring and is compatible with 3 Tesla MRI environments. The system brings a comprehensive array of features and accessories, including those specifically designed for pediatric and neonate patients, to MRI environments of up to 3 Tesla. Veris can also be equipped with gas technology through the integration of the Criticare respiratory analyzer. Veris is available in six configurations to meet specific customer needs for anesthesia, sedation, cardiac MR, research and basic patient monitoring.
EPIX Pharmaceuticals (Cambridge, Massachusetts) reported initiation of a Phase II proof-of-concept trial for EP-2104R, its injectable MRI agent designed to detect blood clots throughout the body. In a Phase I trial, completed late last year, EP-2104R was well-tolerated by healthy subjects at all doses. The Phase II proof-of-concept program is being conducted at multiple sites worldwide to further test safety and test preliminary efficacy of EP-2104R for the evaluation of blood clots in patients presenting with strong suspicion of clots from thrombo-embolic disease. EP-2104R-enhanced MR imaging will be compared to other diagnostic imaging tests to determine the location and size of blood clots. About 40 patients are expected to be enrolled in the trial. EPIX is collaborating with Schering (Berlin) in the development of EP-2104R.
Mediscience Technology (Cherry Hill, New Jersey) said that it is in development of an adjunctive instrument, called the Cancer Detection Map (CD-Map), to facilitate the acquisition of fluorescence images from surgical breast specimens following lumpectomies and surgical procedures. The instrument will be used to define the margins of tumors at the point-of-care, allowing the physician to achieve clear margins in real time during cancer surgery without the use of invasive agents. The CD-Map is highly sensitive and can acquire images in less than one second. Zoom capability allows the CD-Map to acquire images over an area that can vary from sub-centimeters to several centimeters with a resolution better than 100 mm. The CD-Map is a UV/visible fluorescence imaging system designed to gain image emission from native fluorophors in tissue. A tunable light source and movable filters permit the acquisition of images at multiple combinations of emission and excitation wavelengths. Intensity ratio maps are computer generated from the fluorescence images and either the intensity images or pseudo-color ratio images are displayed.
Molecular Devices (Sunnyvale, California) reported the introduction of two new reagent products for adsorption, distribution, metabolism and excretion (ADME) assay screening Transil Membrane Affinity and Transil Human Serum Albumin (HSA) Binding assay kits. The Transil assay kits provide lead optimization and high-throughput screening laboratories with fast, automatable, direct, biologically relevant solutions to increase the throughput of ADME-related compound profiling. The Transil Membrane Affinity assay provides data using beads coated with a lipid bilayer that mimic interactions between compounds and cell membranes. The results are equivalent to the liposome "gold standard" method, without the tedious preparation of liposomes, the company said. The Transil HSA Binding assay kit contains beads coated with human serum albumin and pre-dispensed into a microplate format. The pre-dispensed format increases throughput via parallel sample preparation and assay reading on Molecular Devices' SpectraMax microplate readers. The kits are available in two formats, for 96- or 384-well microplates.
Radiometer (Westlake, Ohio) said its new TCM40 provides continuous and non- invasive monitoring of oxygen and carbon dioxide, together with oxygen saturation levels, using Nellcor (Pleasanton, California) sensors. The company said this advanced capability makes the new monitor ideal for neonatal and sleep units, as well as adult critical care. Two separate sensors mean that the SpO2 is measured continuously, even when the transcutaneous electrode is being calibrated. Fast and reliable results are ensured by a pair of advanced special features: SmartHeat stabilizes transcutaneous values by increasing electrode temperature by one degree during the initial five minutes of measurement, while SmartTrend uses a unique algorithm to improve the stability of measurements to reflect true physiological changes in patient status. A Windows-based interface, onboard video tutorials, stable sensor performance and complete portability add to the new monitor's advantages, the company said. It also offers both analog and serial outputs, connection to PCs for downloading and storing data, as well as connection to a standard printer for printing reports.