A Diagnostics & Imaging Week
BG Medicine (Waltham, Massachusetts) reported signing a Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI) and Boston University (BU).
The three parties will jointly conduct a series of biomarker discovery studies for heart disease and early detection of metabolic syndrome – a combination of certain risk factors, including abdominal obesity, hypertension, and insulin resistance – which are believed to increase the risk of developing cardiovascular disease and diabetes.
BG Medicine's highly advanced technology, which can detect and validate subtle biological changes at the molecular level, will analyze biosamples obtained during years of collection by Framingham Heart Study researchers. The Framingham Heart Study is funded by NHLBI and conducted in collaboration with BU's School of Medicine and School of Public Health.
The collaborative research aims to identify those at high risk of heart attack and stroke, two of the world's leading killers.
The study – Systems Approach to Biomarker Research in Cardiovascular Disease (SABRe CVD) – may also aid pharmaceutical companies in developing novel medicines to prevent or treat these conditions.
The collaboration is the first time in the Framingham Heart Study's 60-year history that it is partnering with a commercial company in a CRADA research project.
"This research partnership could ultimately lead to simple blood tests for heart disease that could help us identify high-risk individuals earlier so they can take action sooner to prevent heart attacks and stroke," said NHLBI Director Elizabeth Nabel, MD.
In other agreements/contracts news:
• Imaging Diagnostic Systems (Fort Lauderdale, Florida) said it has redefined its marketing strategy and launched a new campaign focusing on the international market. While attending the Arab Health Exhibition and Congress in Dubai, United Arab Emirates, IDSI company management secured new distributors for the United Arab Emirates and hired a managing director to market the CT Laser Mammography System in the UAE and parts of the Middle East.
• DR Systems (San Diego) reported four new contracts, including two data migrations from legacy PACS, totaling almost $1.57 million. The four facilities are Hillsdale Community Health Center (Hillsdale, Michigan), Salem Clinic (Salem, Oregon), Contemporary Imaging Associates (Livonia, Michigan) and Advanced Radiology Imaging Associates (Fort Myers, Florida).
"Had these new customers selected a PACS from a different company, they would probably have to maintain five or more different systems and interfaces and deal with five different vendors," said Rick Porritt, President/CEO of DR Systems. "In addition to the complexities of managing all that, they would also have a PACS that cost more and did less than the one they got from DR Systems," Porritt said. "We provided them one unified system that will be a lasting solution – while raising their profitability and simplifying their tech support."
• BioImagene (Cupertino, California) and Visuvi (Redwood City, California) reported a partnership for PathSearch, a visual search product for digital pathology. PathSearch enables visual search for PathXchange community pathology portal and Virtuoso end-to-end digital pathology solutions. This partnership will allow pathologists to search with images without the need for detours via meta-data, potentially incorrect mark-ups and tags.
• AMDL (Tustin, California) reported that it has entered into a collaborative agreement with Mayo Clinic (Rochester, New York) to conduct a clinical study for the validation of AMDL's FDA-approved DR-70 (FDP) cancer test.
Through this validation study, AMDL and Mayo Clinic will perform clinical diagnostic testing to compare AMDL's DR-70 (FDP) cancer test with a new test. The primary goal of the study is to determine whether DR-70 (FDP) serves as a higher-performing test to its existing predicate test and can lead to improved accuracy in the detection of early-stage cancers. For FDA approval on the new test, AMDL intends to perform an additional study to demonstrate the safety and effectiveness in monitoring colorectal cancer.
• SAS (Cary, North Carolina) said it will provide bioassay analyses and visualization capabilities for BioMimetic Therapeutics. (Franklin,Tennessee) through SAS' Visual Data Discovery for Midsize Business.
BMTI develops bioactive recombinant protein-device combination products for healing musculoskeletal injuries and disease for a broad range of orthopedic clinical indications. Currently under way is a North American pivotal clinical study to assess the safety and efficacy of Augment Bone Graft, BioMimetic's lead orthopedic product candidate.
"We needed clinical trial reporting and repeatable, programmable statistical computations, from t-tests to Kolmogorov-Smirnov tests, from linear models to survival analysis and mixed models, and everything in between," said Rafe Donahue, PhD., associate director, statistics at BioMimetic. "Using SAS, we now see data from our clinical trials in formats other than spreadsheets. We can pinpoint issues as they manifest, and be more nimble."
• Sonoco (Hartsville, South Carolina) reported an agreement with Swiss Precision Diagnostics (SPD; Geneva) to provide packing services for SPD's pregnancy diagnostic kits at Sonoco's Pack Center in Strykow, Poland.
"Sonoco was chosen because of its great reputation and proven results in consumer packaging," said Scott Majestic, director of product supply with SPD.