Advanced Magnetics (Cambridge, Massachusetts) reported that it has received an "approvable" letter from the FDA regarding Combidex, its investigational functional molecular imaging agent. The FDA requested additional data to demonstrate the efficacy of Combidex, and suggested that the data be limited to a well-defined population of specific cancer types. The agency indicated that its principal issues relate to the topics addressed by the Onocologic Drugs Advisory Committee on March 3, primarily how the data submitted by the company could be generalized across all tumor types. "We intend to continue our active dialogue with the FDA to determine the necessary next steps to achieve approval for Combidex," said Jerome Goldstein, chairman, president and CEO of Advanced Magnetics. "Until we establish the nature of what the FDA believes will be acceptable additional data, we cannot speculate on what we may have to do to address the FDA's concerns or how long the process will take."
Alerion Biomedical (San Diego) said results using its two new contrast agents for microCT and CT (computed tomography) imaging were featured in eight abstracts and presentations by researchers during the Academy of Molecular Imaging annual meeting in Orlando, Florida, which ended yesterday. Compatible with both microCT and standard CT imaging systems, Fenestra allows researchers to view anatomy and function in a wide range of animal models. Fenestra can be administered repeatedly to the same animal, eliminating the need to sacrifice and assay multiple animals at various time points in longitudinal studies. Fenestra LC provides both prolonged contrast enhancement of the entire hepatobiliary system as well as functional imaging information about the liver and biliary tract in preclinical animal studies. Fenestra VC provides sustained contrast enhancement of the entire vascular tree from a single administration.
Biomarker Technologies (Phoenix), a technology provider of the blood diagnostic test for the detection of breast cancer called the BT Test, reported plans to begin a pilot study of the test in the U.S. beginning in April 2005. The company is conducting the pilot study to verify its prior results and make final preparations for FDA clinical studies. The study will be a retrospective blind test with samples from healthy participants, those with untreated breast cancer, as well as those from a select group of other cancer conditions in order to demonstrate the differentiation capabilities of the test. The BT Test is designed to detect the presence of breast cancer at the molecular level, unlike mammography, which only detects masses or gross changes in breast tissue via an X-ray photograph. The test measures five key cancer-associated biomarkers that can detect breast cancer when combined and adjusted for age.
Cybernet Medical (Ann Arbor, Michigan), a developer of biometric monitoring technologies for outpatient care, said its MedStar Disease Management Data Collection System now offers enhanced Internet video capabilities and web-based management tools for improving the monitoring of homebound chronic disease patients with wound care needs. The MedStar system, used to remotely collect and transmit a patient's physiological data, supports the high-resolution camera output that is especially beneficial in wound care management programs. Through MedStar, chronic disease patients including those in harder-to-reach rural areas can receive regular contact with a healthcare provider. The MedStar device collects data directly from measurement tools such as blood pressure cuffs and glucose monitors and transmits it to a collection server over a standard telephone line. The MedStar's compatible videophones can also transmit reliable, high quality images over regular phone lines or the Internet. For healthcare providers, MedStar now offers web-based wound care management tools such as a measurement device that visually assesses the healing process via successive digital images.
Medical Care Corp. (MCC; Irvine, California), a developer of knowledge-ware that enables identification and treatment of Alzheimer's disease (AD) and related disorders, said a study published in The Proceedings of the National Academy of Sciences showed that by applying statistical modeling to the neuropsychological test battery used by the National Institute of Aging's Disease Research Centers, the overall accuracy for distinguishing normal aging from the mildest stage of AD increased to 97%. The statistical model allows doctors to more accurately detect patients with mild cognitive impairment, a condition that precedes dementia caused by AD, enabling patients to start treatment at an earlier, more beneficial stage. The study was conducted over the course of 15 years and included 471 subjects. MCC developed the analytical technology used in the study.
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that it has submitted to the FDA an amendment to its corporate investigational new drug (IND) application for Lymphoseek. The amendment submission included updated results from clinical and preclinical evaluations completed to date with Lymphoseek. In addition, Neoprobe's submission included a complete draft of a proposed multi-center clinical evaluation of Lymphoseek and the Investigator's Brochure for the conduct of the study. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types. In connection with the establishment of the corporate IND for Lymphoseek, the FDA provided guidance that it would prefer to have Lymphoseek evaluated in a multi-center clinical study to confirm the findings observed by the University of California, San Diego researchers. The initial multi-center trial would then be followed by a confirmatory Phase III study using the final cGMP material. Neoprobe said it intends to begin enrollment in the first of the two multi-institutional studies as soon as the appropriate regulatory and institutional review board clearances are received.
Planar Systems (Beaverton, Oregon) reported the release of Dome Dashboard, a software console application that simplifies the centralized management, monitoring and control of medical imaging displays for administrators of picture archiving and communications systems. In conjunction with Dome CXtra software, the monitoring and calibration software included with all Dome medical imaging display systems, administrators use Dome Dashboard to set up alerts for immediate pages when a display changes in any unexpected way.
Spacelabs Medical (Issaquah, Washington) has introduced TruLink SpO2 Sensors, a new line of reusable and single-patient use pulse oximetry sensors, in a variety of sizes ranging from neonate to adult. TruLink SpO2 Sensors can be used with all Spacelabs Ultraview Command Modules and UltraviewSL Command Modules. The new line is also compatible with a wide variety of other manufacturers' patient monitors as well as Nellcor (Pleasanton, California) pulse oximeters. The "C" shape design of the single-patient-use sensors affords an improved fit for patient comfort and can be reapplied to the same patient. Reusable sensors include both a finger clip and "Y" probe that are convenient to apply and provide a secure fit to a range of patients.
Stratagene (Garden Grove, California), a manufacturer of specialized research and diagnostic products, reported that its wholly owned subsidiary, Hycor Bio-medical, has received FDA clearance to market its Anti-Tissue Transglutaminase (tTG) IgG autoimmune test. tTG is used in the diagnosis of celiac disease. The new test complements the tTG IgA test cleared by the FDA in 2004. The company said all of its tests can be performed using a manual procedure or the procedures can be fully automated by using its HY-TEC 288 Plus Automated Immunoassay System.
Tensys Medical (San Diego), a leader in real-time blood pressure management, reported the introduction of the TL-150, a continuous, non-invasive blood pressure monitoring system with accuracy clinically proven equivalent to an arterial line. The company said the TL-150 introduces significant technological advancements over the original T-Line system, including improvements such as reduced set-up time and improved motion tolerance. The non-invasive, beat-to-beat capability of the new TL-150 enables continuous monitoring of even the most difficult surgical patients and provides the confidence of real-time feedback on the impact of interventions for optimal blood pressure management, Tensys said.
Tessera (Seattle), a biomedical company developing products for the early detection of prostate and colon cancer, said it has released its first product, ProstaMark EPCA (Early Prostate Cancer Antigen), as an analyte-specific re-agent for commercial use in pathology laboratories to assist pathologists in their efforts to determine if cancer is present in the prostate. Tessera's EPCA test is now available at Unipath (Denver) and will soon be offered by pathology laboratories throughout the country, as well as major prostate cancer centers. Tessera has contracted Chemicon International (Temecula, California), a subsidiary of Sero-logicals (Norcross, Georgia), to manufacture the ProstaMark EPCA product.
Toshiba America Medical Systems (Tustin, California) said clinical researchers at Beth Israel Deaconess Medical Center (BIDMC; Boston) reported the completion of the first chest pain evaluation using electrocardiogramgated (ECG-gated) imaging performed with the Toshiba Aquilion 64. Featuring advanced multi-detector computed tomography (CT) technologies, the Aquilion 64-detector CT uses Toshiba's 64-row Quantum detector, which enables the Aquilion CT scanner to acquire 64 simultaneous slices of 0.5 mm for precise volumetric imaging of any region of the body during a breath-hold under 10 seconds. At BIDMC, a patient with chest pains and significant shortness of breath during exertion was scanned with the recently installed Aquilion 64 to determine if the symptoms were related to a problem with the lungs or the heart. "We are just beginning to realize the full potential of using the Aquilion 64-slice CT, and we fully expect a leap in image quality from the previous 16- and 32-slice CT technology," said Melvin Clouse, MD, professor of radiology and director of research at BIDMC. Clouse recently discussed the results of the latest clinical studies performed with the Aquilion 64 at Snowmass 2005: Imaging with CR and MR meeting in Colorado in February.
Toshiba Medical Systems (Tokyo) reported the beginning of patient evaluations in what it said is the industry's first multi-center clinical study on coronary computed tomography angiography (CTA) imaging using 64-slice CT technology. Initial results of the study will be released in 2006. In November 2004, Toshiba launched CorE 64 (Coronary Evaluation on 64), an international collaboration with its partners to investigate the use of multislice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. The patient evaluations will involve non-invasive diagnostic imaging of cardiac patients using Toshiba's CT technologies, such as the Aquilion CFX 64-slice CT, 64-row Quantum Detector and SURECardio and SUREPlaque applications for a period of several months, as well as regular meetings with the study group to measure and discuss the clinical effectiveness of cardiac CT imaging against cardiac catheterizations.