A Diagnostics & Imaging Week
Osmetech (Pasadena, California), an international molecular diagnostics company, said it has signed an agreement as principal supplier of Warfarin Sensitivity tests for a major new U.S. trial sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.
Investigators for the upcoming Clarification of Optimal Anticoagulation through Genetics Trial (COAG Trial) have selected Osmetech's Warfarin Sensitivity tests and eSensor XT-8 molecular diagnostics instrument platform for 10 of the 12 sites identified to run the trial. The University of Pennsylvania (Philadelphia) is the coordinating center for the trial.
The study has been designed as a 1,238-patient, randomized, double-blind trial which will examine the utility of using genetic information for warfarin dosing.
Specifically, the COAG Trial will test two approaches to determining the initial dose of warfarin in patients who are expected to need therapy for three months or longer. Half of the participants enrolled in COAG will be randomly selected to have their initial dose determined by clinical information alone.
For the other half of the participants, the initial dose will be determined by using the clinical factors as well as information about the participant's genetic makeup, specifically his or her variants of the CYP2C9 and VKORC1 genes. All participants will be monitored for up to six months.
Researchers will assess how long participants in each group maintain the desired level of blood thinning, as determined by a blood test, at two and four weeks after starting therapy, as well as at three and six months. Researchers will also review bleeding problems and other complications, quality of life and cost of therapy.
"The high level of performance of our eSensor XT-8 System and Warfarin Sensitivity test in the market since commercial launch in the second half of 2008 continues to gain recognition and this contract award should further enhance market acceptance of our platform," said James White, CEO of Osmetech. "Osmetech has won an opportunity to participate in a major study which will demonstrate the significance of genetic and clinical data in the prescription of a patient's initial warfarin dose. The strength of our eSensor XT-8 platform and pipeline of tests puts us in an excellent position to benefit from the growing trend towards personalized medicine."
Warfarin is an oral anticoagulant widely used for the prevention of thrombotic events and to treat a confirmed episode of venous thrombosis, with roughly 2 million new patients each year in the US alone. Although highly effective, warfarin's usability is limited by a narrow therapeutic range combined with a pronounced interindividual variability in the dose required for adequate anticoagulation.
Clinical use of warfarin is further complicated by a substantial risk for hemorrhagic side effects, which is increased in patients with low-dose requirements. Warfarin is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalization, according to Osmetech.
In other agreements/contracts news:
• Oxygen Biotherapeutics (Costa Mesa, California) said it has signed a research and development agreement with the Naval Medical Research Center (NMRC; Silver Spring, Maryland) and the Walter Reed Army Institute of Research (Washington), federal laboratories of the Department of Defense.
The company said it would provide information that would be used by NMRC and Walter Reed for preparation, writing, and submission to the FDA of an investigational new drug application for the use of Oxycyte for the treatment of decompression sickness. Oxycyte is the company's perfluorocarbon therapeutic oxygen carrier.
Oxygen Biotherapeutics is developing pharmaceuticals and medical devices in the field of oxygen therapeutics and Defense Medicine. The company has under development a perfluorocarbon therapeutic oxygen carrier and liquid ventilation product (Oxycyte) and has out-licensed an implantable glucose sensor.
• Quest Diagnostics (Madison, New Jersey) said it would enable patients and their physicians to share diagnostic laboratory test results using Microsoft HealthVault. According to the company, the connection will enable physicians who use Quest Diagnostics' Care360 patient-centric physician portal to securely transfer, at a patient's request, diagnostic laboratory test results in a HIPAA-compliant format into the patient's protected account. Patients will be able to use their account to access current and historical diagnostic laboratory records from their physicians.
Quest provides diagnostic testing, information and services. Microsoft HealthVault allows users to store, organize and manage their medical records and personal health information online.
• SonoSite (Bothell, Washington) reported that Medical Simulation (MSC; Denver) has selected SonoSite's M-Turbo ultrasound as its preferred system for teaching clinicians central line placement procedures for their SimSuite Central Line Management Program.
According to the company, SonoSite's M-Turbo technology enables clinicians to confidently perform central line placement procedures. The system's imaging technologies – SonoMB, SonoHD, and SonoAdapt – provide healthcare professionals with crystal-clear imaging, better edge detection and needle recognition for ultimate visual guidance.
SonoSite develops hand-carried ultrasound. MSC provides full-service simulation training and education services to healthcare personnel, medical societies and medical product manufacturers.
• TriLink BioTechnologies (San Diego) reported an agreement with Osmetech Molecular Diagnostics (Pasadena, California) to supply reagents for Osmetech's recently launched eSensor Cystic Fibrosis Carrier Detection (CFCD) system and the eSensor XT-8 system for Warfarin sensitivity.
TriLink is providing Osmetech with custom oligonucleotides, which are required reagents for the eSensor detection systems, the companies reported.
TriLink makes custom oligonucleotides, modified nucleoside triphosphates and CleanAmp PCR products for the diagnostic and OEM markets.
• BD Diagnostics (Franklin Lakes, New Jersey) and HandyLab (Ann Arbor, Michigan) reported an exclusive agreement for BD to commercialize its molecular assays on a new BD MAX system, an automated molecular diagnostic testing platform in development using HandyLab's recently launched Jaguar instrument. BD will focus initially on its BD GeneOhm line of molecular assays to detect major pathogens associated with healthcare-associated infections.
Released by HandyLab in November 2008, the Jaguar system is the first fully integrated bench-top molecular diagnostic system to provide hands-off operation, according to the company. The system incorporates clinical sample preparation, nucleic acid extraction, and microfluidic real-time polymerase chain reaction (PCR) amplification and detection. The self-contained workstation is designed to accommodate on-demand and batch workflows. It requires minimal laboratory space and minimal skill levels to generate up to 24 real-time PCR results in under two hours.
• Alpine Biomed (Fountain Valley, California) reported an agreement with Given Imaging (Yoqneam, Israel) to enhance its gastrodiagnostic testing capabilities. The company's GastroTrac gastroenterology software suite will interface with Given Imaging's Bravo pH Monitoring System to provide doctors with a single system for their gastrointestinal testing needs.
Alpine will incorporate the Bravo pH software into a fully integrated version of GastroTrac with a comprehensive range of tests including catheter-based pH monitoring, upper and lower GI motility testing, electrogastrography and biofeedback. To simplify patient records, the Bravo pH software will share the GastroTrac database with the catheter-based pH monitoring studies. Alpine's VersaFlex pH catheters and the Bravo pH capsule are the only pH devices validated for use on the integrated GastroTrac system, the company noted.
Two well-known names in diabetes management – Medtronic (Minneapolis) and Eli Lilly (Indianapolis) – have reported a marketing collaboration intended to bolster each company's commitment to help people with diabetes manage their blood sugar using insulin therapy.
Working collaboratively with health care professionals, Medtronic and Lilly marketing and sales operations in the U.S. will work to improve the delivery of diabetes education for insulin-taking patients and their caregivers. This includes the development of new educational resources and classes around the initiation and intensive management of insulin, insulin pump therapy and continuous glucose monitoring (CGM).
According to the companies, the alliance combines the insulin expertise of Lilly with the advanced diabetes technologies of Medtronic, the world's largest manufacturer of insulin pumps and CGM, and maker of the world's only integrated diabetes management system that combines the power of insulin pump therapy with CGM.
"Medtronic and Lilly are joining together to help improve patient access to high-quality diabetes education," said Chris O'Connell, president of the Diabetes business unit and senior VP at Medtronic. "Because diabetes management is complicated, it is crucial that physicians and patients have the best access to information and educational resources. This collaboration will generate greater awareness and enable more people to benefit from the latest educational tools regarding insulin pump therapy and continuous glucose monitoring."
"People with diabetes have numerous treatment options and devices to help manage blood sugar, but physicians and patients need resources and solutions to integrate these improvements into real-world therapy," said Matt Beebe, Diabetes brand leader at Lilly USA. "With this alliance, Lilly and Medtronic hope to create integrated solutions to address challenges for people taking insulin who need optimal glycemic control. By joining forces, we will help make insulin therapy more achievable by offering new educational materials and resources that help make insulin pump therapy fit into patients' lives."
• Guided Therapeutics (GT; Norcross) reported an agreement with Konica Minolta Opto (Tokyo) to co-develop non-invasive cancer detection products. The new development agreement follows two years of collaborative preparations to identify large market opportunities that would benefit from GT's technology, the company said.
The new products, for the detection of lung and esophageal cancer, are based on GT's LightTouch non-invasive cervical cancer detection technology, which is currently under FDA review for premarket approval.
GT says it is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to provide an objective result at the point of care thereby improving the management of cervical disease. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately, the company noted.