• Acacia Research (Newport Beach, California) said that its CombiMatrix group has launched the ElectraSense Influenza Typing System based on CombiMatrix's electrochemical detection technology and its Influenza A Typing Microarray. The CombiMatrix Influenza A typing microarray can identify all strains of Influenza A, including the pathogenic H5N1 strain. CombiMatrix is prepared to make this system available to domestic and international government agencies that are engaged in monitoring influenza and planning for a potential pandemic. Using this system, government agencies can verify, before disseminating potentially alarming information to the public, whether samples contain a highly pathogenic substrain of H5N1 or one of the several non-lethal substrains of H5N1. The portable system eliminates the bulk, complexity, delicate lasers, and fluorescent dyes common with existing technologies. CombiMatrix will seek FDA approval for the product.

• CardioDynamics (San Diego), a developer of impedance cardiography (ICG) technology, reported publication of data from the ED-IMPACT trial, which demonstrated that information from its BioZ ICG device resulted in a change in treatment 39% of the time and a change in emergency department diagnosis 13% of the time in patients presenting with shortness of breath. The results were published online in Academic Emergency Medicine, and will be published in print version of the journal in April.

• Cytyc (Marlborough, Massachusetts) said that studies evaluating its ThinPrep Imaging System for cervical cancer screening were presented at the recent American Society for Colposcopy and Cervical Cancer meeting in Las Vegas. One study examined the incremental value of high-risk human papillomavirus DNA testing in combination with the ThinPrep Imaging System. The second study compared the cost-effectiveness of cervical cancer screening with the ThinPrep Imaging System compared to various other cervical screening strategies. The studies demonstrate the potential clinical and cost benefits of the ThinPrep Imaging System, the company said.

• DexCom (San Diego) reported that it has received FDA approval for its STS Continuous Glucose Monitoring System, a first-generation device designed to help people with diabetes more conveniently and effectively manage their blood sugar levels. The DexCom STS consists of a tiny wire-like sensor that is inserted by the patient just under the skin. The sensor continuously measures glucose levels which are transmitted wirelessly to the cell phone-like STS Receiver. With the push of a button, the hand-held receiver provides the patient with real-time glucose measurements and trends, as well as providing alerts to warn of high and low glucose levels.

• Dilon Technologies (Newport News, Virginia), manufacturer of the Dilon 6800 Gamma Camera, said results of two clinical studies at the annual meeting of the National Consortium of Breast Centers in Las Vegas demonstrate the value of breast-specific gamma imaging (BSGI) in the identification of two hard-to-detect cancers: ductal carcinoma in-situ (DCIS) and invasive lobular carcinoma (ILC). BSGI is a nuclear medicine procedure that images the metabolic activity of breast lesions through radiotracer uptake, specifically imaged using a high-resolution, small field-of-view, anatomic-specific gamma camera, the Dilon 6800. In the first study, the authors concluded that BSGI has a higher sensitivity in detecting DCIS than MRI, even when the cancer is less than 1 cm in size. In another study on detection of ILC using the Dilon 6800, the authors concluded that BSGI is a highly sensitive imaging modality in detecting ILC, a cancer that is often difficult to detect mammographically, with ultrasound or with physical examination.

• IRIS International (Chatsworth, California), a manufacturer of automated IVD urinalysis systems and medical devices used in hospitals and clinical reference laboratories worldwide, said it unveiled its new iChem 100 Urine Chemistry Analyzer at the Clinical Laboratory Management Association ThinkLab ‘06 conference in Charlotte, North Carolina. The iChem100 analyzer, its associated iChem Urine Chemistry Strip and the visual read vChem Urine Chemistry Strips product lines, were introduced to nearly 3,500 laboratory professionals who attended the exhibition at the Charlotte Convention Center. The iChem100 is a semi-automated, benchtop instrument designed for small clinical laboratories testing up to 50 samples per day, which include small hospitals, outpatient clinics, alternate care facilities, nursing homes and large physician offices.

• Masimo (Irvine, California) reported FDA clearance of the Rainbow SET Rad-57cm Pulse CO-Oximeter, a hand-held, continuous monitor that analyzes data from 8-wavelength finger sensor to measure arterial oxygen saturation, carbon monoxide, methemoglobin and pulse rate. Building on Masimo's Rad-57 launched in 2005, the Rad-57cm adds the ability to measure methemoglobin, which compromises the blood's ability to carry oxygen and can be life-threatening.

• Matritech (Newton, Massachusetts), a developer of protein-based diagnostic products for the early detection of cancer, said data on its point-of-care NMP22 BladderChek Test were presented at the Society for Gynecologic Investigation meeting in Toronto, showing that it detected 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for bladder cancer. The NMP22 BladderChek Test was also positive for seven conditions that required biopsy for diagnosis. The clinicians noted that the test has the potential to be an effective screening tool in identifying aggressive lesions early and improving prognosis in women at risk for bladder cancer. The NMP22 BladderChek Test detects elevated levels of the NMP22 protein marker in a single urine sample. The noninvasive assay is the only in-office test approved by the FDA for the diagnosis of bladder cancer.

• Molecular Insight Pharmaceuticals (Cambridge, Massachusetts) reported the start of a Phase II clinical trial to develop a reference database of normal Zemiva images of the heart using SPECT imaging. The normative trial is part of the company's ongoing clinical program to develop Zemiva (iodofiltic acid I 123) analog for the diagnosis of cardiac ischemia in chest pain patients in the emergency department setting. The normative trial will include about 120 patients at 12 centers in North America. It follows earlier Phase II safety and efficacy studies of Zemiva, a radiolabeled fatty acid, and will be completed in about six months. Molecular Insight said it intends to use the Normals reference database in its registration trials for Zemiva and in commercialization of the product, if approved by the FDA.

• Nanogen (San Diego), a developer of advanced diagnostic products, reported that it has expanded its molecular reagent product portfolio with analyte specific reagents (ASRs) designed to detect 23 wild type and mutation sequences associated with cystic fibrosis. The U.S. launch of the product took place at the American College of Medical Genetics meeting in San Diego. The new CFTR ASR products are part of the company's NGEN brand of reagents for molecular applications. Assays using NGEN CFTR ASRs, once validated by the laboratory, can be used as a clinical diagnostic test. The products will be CE marked in Europe for in vitro diagnostics and will be available in the U.S. as ASRs for which analytical and performance characteristics are not established.

• Omron Healthcare (Bannockburn, Illinois) reported the introduction of the VP-Series, a noninvasive vascular profiling system capable of measuring Ankle Brachial Index (ABI), Pulse Wave Velocity (PWV) and Augmentation Index (AI), at the recent American College of Cardiology meeting in Atlanta. The VP-Series, based on Waveform Analysis and Vascular Evaluation technology, includes the VP-1000 and its more enhanced sister model, the VP- 2000. The VP-1000 ensures accurate and reliable ABI results by using advanced oscillometric technology that includes simultaneous blood pressure measurements at all four limbs, a dual chamber cuff system and a proprietary algorithm. The VP-1000 also measures PWV, an index of arterial stiffness. The VP-2000 has advanced multi-element micro sensors for measuring pulse waves based on tonometry at the carotid and femoral arteries. It can provide more specific arterial information of the central vasculature through carotid-femoral PWV and carotid AI.

• Verimetrix (Clayton, Missouri) reported the introduction of Veriscan, the first automated endoscope leak testing technology. Veriscan transforms the critical leak testing procedure during endoscope reprocessing into a precise, repeatable and documented process that reduces total repair costs by about 50% while lowering cross-patient infection risk. Veriscan's pneumatic, sensor and microprocessing technology automatically detect leaks with greater accuracy – 98% detection accuracy vs. about 65% for current methods. Additionally, the device also detects the presence of fluid within the endoscope. A unique feature to the Veriscan is the ability to automatically record each leak test and retrieve it on command via the LCD display, printing or downloading to a computer, allowing medical institutions to analyze endoscope damage, track procedure activity, and ensure every endoscope is properly leak tested.

• VisEn Medical (Woburn, Massachusetts), a provider of optical imaging technologies for biomedical research, introduced at the Academy of Molecular Imaging meeting in Orlando, Florida, the first three products in its NanoSparks line of optical imaging probes. AminoSpark680 is a super-bright and robust platform label that can be readily conjugated to a range of targeting molecules, enabling custom tailored molecular imaging in multiple disease areas. CellSpark680 is a nanoparticle label used to track the location and movement of cells in vivo, a key tool for research in cell trafficking in vivo with subsequent fluorescence activated cell-sorting analysis. AngioSpark680 is a nanoparticle probe that enables ultra-long and ultra-bright fluorescent imaging of vascularity and angiogenesis, tailored for applications in intravital microscopy. The company said the NanoSpark products will be available for sale in 2Q06 and plans to launch additional NanoSpark products later in the year.