A Diagnostics & Imaging Week

VisEn Medical (Woburn, Massachusetts) has signed an exclusive Japanese distribution agreement with Olympus (Tokyo) covering VisEn's fluorescence molecular tomography (FMT) imaging systems and portfolio of in vivo near-infrared fluorescence probes. Olympus will begin selling the products in Japan as of Sept. 1

The FMT systems and near-infrared fluorescence probes were developed to enable leading in vivo performance in fluorescence molecular imaging.

The companies said that by combining VisEn's products with the Olympus OV100 and IV100 molecular imaging systems, it will be possible to generate an "unprecedented range" of molecular imaging data in vivo, from the cellular and tissue levels to the quantification of molecular activities, real time within the whole body.

They said these products would accelerate progress in disease research and in drug development by "significantly expanding molecular imaging applications and enhancing data quality in diseases including cancer, inflammation, cardiovascular disease and bone disease."

In vivo molecular imaging is now widely used in advanced life science research to observe and analyze the dynamics of cells, proteins and molecules, making it possible to detect and characterize diseases earlier, and to achieve a better understanding and characterization of the mechanisms that cause such diseases and the effectiveness of related treatments.

VisEn said near-infrared fluorescence imaging using biocompatible molecular probes is "an extremely effective and highly sensitive method of in vivo imaging and is increasingly playing a central role in disease research and drug development, from animal research today through medicine tomorrow.

VisEn's fluorescence probes are designed to target and read out various disease-related molecular activities in vivo, including protease activity, angiogenesis, vascular permeability and bone turnover. The company said its FMT system "provides true quantification of fluorescence within the living animal."

Together, the companies said their technologies can be used to observe and quantify a range of biological phenomena in vivo, including molecular activities in disease states such as cancer, inflammation, cardiovascular disease and bone disease.

The systems developed by Olympus are the OV100 in vivo imaging system for a wide range of observations, from full views of small animals to the cellular level, and the IV100 in vivo laser scanning microscope, which supports direct in vivo observation of small animals.

Olympus said that signing an exclusive Japanese distribution agreement with VisEn will allow it to combine its imaging systems with VisEn's products, enabling Olympus to supply its customer with fluorescence technologies that can be used for in vivo observations and data generation from cells and tissues throughout the entire body.

Hiroyuki Yoshimori, division manager of Olympus' Bio Business Division, said, "Because of its power and sensitivity in imaging molecular activities in vivo, near-infrared fluorescence imaging is playing an increasingly central role in research and drug development. VisEn's technology platforms bring a clear level of technology and market leadership to our programs in the space. These platforms and the data they generate . . . will ultimately enable doctors to see, understand and treat disease in new and better ways tomorrow."

Kirtland Poss, president and CEO of VisEn, said, "Olympus is a clearly recognized leader in developing and marketing top-quality systems for both the research and clinical markets, and they have a growing emphasis on bringing the industry's central fluorescent technologies from translational research into personalized medicine. Our combined technologies, products and shared vision in molecular imaging will have a major impact in providing real time readouts of biologic activity in a wide range of disease states."

VisEn's FMT system and in vivo near-infrared fluorescence probes will be on display at the 65th annual meeting of the Japan Cancer Association, which will be held at Pacifico Yokohama from Sept. 28-30.

VisEn Medical was established based on technologies developed at Massachusetts General Hospital and Harvard Medical School (both Boston). The company is financed in part from major venture funds, including Flagship Ventures and The Bollard Group.

PREVU reader OK'd in Canada

Predictive medicine company PreMD (Toronto) said that its second-generation spectrometer, or color reader, for the PREVU(x) Point of Care Skin Sterol Test has been cleared for sale by Health Canada's Therapeutic Products Directorate (TPD).

"This clearance allows the new reader to be marketed in Canada and follows on the CE mark designation we recently received for the reader in Europe," said Dr. Brent Norton, president and CEO. "We anticipate that this stand-alone, portable reader will enhance the appeal of PREVU(x) POC in all markets."

The new reader was developed in conjunction with Boehringer Ingelheim microParts and will be manufactured in the U.S. by Jabil Circuit.

PREVU(x) non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to blood. There is no fasting or other patient preparation required for the test. PreMD said clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of coronary artery disease.

PillCam gets push to French reimbursement

Given Imaging (Yoqneam, Israel) reported that the French National Authority for Health (HAS) has completed the first step in advancing reimbursement for PillCam SB capsule endoscopy for more than 60 million French citizens.

Given said that the HAS which advises the French government on medical reimbursement decisions — last month published a report that highly recommends the use of PillCam SB in patients with obscure gastrointestinal bleeding and Crohn's disease following inconclusive first-line tests. Its report, "Examination of the Lumen of the Digestive Tract by Ingested Video Capsule," was based on an analysis of existing clinical data and physician opinions, concluding that capsule endoscopy provides additional medical benefit and, as a result, recommends including capsule endoscopy in the list of reimbursable procedures, using two previously assigned codes.

Given said that such a recommendation is considered the pivotal step toward achieving universal reimbursement for PillCam SB in France.

The next step will be for the Union Nationale des Caisses Assurances Maladies to set a monetary value for the code, expected in 2007.

Homi Shamir, president/CEO of Given, said, "We expect other national health systems to follow France's lead and allow physicians to use PillCam capsule endoscopy to detect and monitor patients with small bowel illnesses."

The PillCam SB capsule is a naturally ingested method for visualization of the small intestine, currently marketed in the U.S. and in more than 50 other countries.

BioMachines adds SameSpots to analysis offering

Nonlinear Dynamics (Newcastle upon Tyne, UK), a global provider of bioinformatics solutions, said that BioMachines (Research Triangle Park, North Carolina) has selected the company's SameSpots product as the 2-D analysis solution to support its new protein analysis service.

BioMachines says that its Applied Proteomics Services Division offers an integrated technology platform, giving advantages in data quality and throughput. The approach of Nonlinear's SameSpots solution is a key component for delivering the service offering.

SameSpots offers proteomics researchers a breakthrough in the analysis of 2-D single stain and DIGE images by means of a faster 2-D workflow, largely through the elimination of post-analysis editing on the majority of experiments.

The SameSpots approach also guarantees 100% matching across an experiment and no missing values, allowing increased statistical power and new possibilities for 2D based proteomics research, according to Nonlinear Dynamics.

Tom Larrichio, CEO of BioMachines, said, "We implemented the SameSpots approach in our 2-D image analysis workflow as we recognize the significant time savings it offers on what is a labor-intensive process. Applying SameSpots to the aligned images vastly reduces, and even removes in some cases, the need for post-analysis editing — the time-consuming part of 2-D image analysis."