A Diagnostics & Imaging Week

Guardian Technologies International (Herndon, Vir-ginia), a provider of security and healthcare solutions based on Intelligent Imaging Informatics (3i), reported entering an agreement with Dr. H.K. (Bernie) Huang of the Medical Imaging and Informatics Laboratory at the Keck School of Medicine, University of Southern California (Los Angeles).

Huang will lead a multiple-phase process to evaluate and provide feedback on enhancements to Guardian's 3i intelligent imaging analysis solutions as applied to radiology imaging. Guardian said it expects that many of the core features and capabilities deployed for its security products can be utilized for clinical radiology applications.

"3i is very effective at segmenting, clarifying, distinguishing, and identifying organic objects, even when they are masked by one or more other objects of similar density and chemical composition. As with explosives, the human body is made of organic compounds. Therefore, it is a natural extension of the technology to adapt the scientific principles employed for explosives detection to medical image analysis," said Richard Borrelli, Guardian's vice president of business development-healthcare.

He added, "Our product development direction will be focused on the areas of greatest clinical need, finding the best pairing of our 3i-based computer-aided detection technologies with the major challenges in clinical imaging."

Huang, professor of radiology and biomedical engineering at USC, said, "Based on their complex nature and the challenges inherent in imaging and interpretation, we have selected for evaluation what we believe are the three key clinical areas – breast, lungs, and brain. Bringing a technological capability, such as 3i, to these critical challenges will produce major benefits for improved detection and better patient outcomes."

Mammography is a diagnostic challenge due to overlapping layers of soft tissues of various densities, tending to attenuate contrast and conspicuity between normal tissue and cancerous lesions.

Guardian said that its "iterative transformational divergence technology should bring different perspectives in improving breast cancer early detection and diagnosis."

Chest exams represent 70% of all diagnostic imaging procedures, but image interpretation of this common study is complicated by overlapping chest structures. Since the chest X-ray is a 2-D representation of a 3-D object, multiple organs will appear to occupy the same space and obscure 3-D anatomical structures.

Barr Pharmaceuticals (Woodcliff Lake, New Jersey) said that its subsidiary, Duramed Pharmaceuticals (also Woodcliff Lake), and Common Sense (Caesarea, Israel) have entered into a development, manufacturing and supply agreement for the Al-Sense detecting strip, a panty liner-like device that includes a polymer-coated polyester strip designed to detect amniotic fluid, which could indicate a potential problem with a pregnancy.

The parties intend to develop and seek approval to market the product as a medical device in the U.S. and Canada.

"Our partner, Common Sense, has developed a product that we believe physicians and women who have had, or may be at risk of having, amniotic fluid leakage during pregnancy will find very helpful," said Bruce Downey, Barr's CEO and chairman. "The product is a self-administered test designed to identify and detect amniotic fluid leakage utilizing a proprietary polymer-coated polyester strip. If approved, this product would be available to women by prescription and would provide a significant advance in the treatment of female patients at risk for amniotic fluid leakage."

Common Sense said it expects to file a 510(k) application for the product in late 2006 and gain approval in early 2007, and Duramed will make a one-time payment to Common Sense following approval.

Common Sense will manufacture and package the product, which Duramed would then purchase and have responsibility for detailing to physicians and healthcare practitioners utilizing its Duramed Specialty Sales Force. Barr will record net sales of the product and will pay Common Sense for product delivered.

Common Sense manufactures indicators utilizing common hygienic products such as panty-liners and diapers as a platform for "non-intrusive" diagnosis and health monitoring.

In other agreements news:

• Aspyra (Calabasas, California), a global provider of clinical and diagnostic information solutions, entered into a distributor agreement with Merry X-Ray (MXR)/SourceOne Healthcare Technologies (Mentor, Ohio) for MXR to distribute Aspyra's AccessNET PACS and AccessMED Specialty PACS solutions nationwide.

MXR bills itself as the largest nationwide distributor in the X-ray and imaging industry. SourceOne Healthcare Technologies is an MXR subsidiary.

The three-year agreement enables MXR to be a single-point of contact to the imaging and orthopedic customer. "Providing a PACS solution to our customers, such as Aspyra's PACS, allows us to offer a comprehensive portfolio of electronic imaging solutions to our customers," said Jeff Root, director of imaging for MXR.

In 1998, MXR created its Digital Imaging Division to respond to such current needs. MXR's electronic product portfolio includes vendor partners and solutions to meet any digital imaging need – from basic teleradiology to enterprise-wide PACS. MXR represents more than 8,000 products and has 38 branches nationwide.

• BioFortis (Baltimore) reported that the National Cancer Institute (NCI) of the National Institutes of Health (Bethesda, Maryland) has selected its software, Labmatrix, for use within its Center for Cancer Research (CCR).

The CCR, NCI's internal research program, is comprised of multiple labs, branches and core facilities supporting both clinical and basic sciences, with a focus on translational cancer research.

Labmatrix, a web-based, enterprise translational research information management software product, is being used to support human subjects research by seamlessly integrating clinical data with genomic, proteomic and laboratory experimental data, as well as maintain annotated tissue banks. CCR's decision to adopt the Labmatrix technology came after extensive user evaluation within the Neuro Oncology Branch. An analysis was also conducted of requirements to interface with existing CCR infrastructure utilizing caBIG interoperability standards.

Labmatrix' ability to track human biological specimens, IRB (Institutional Review Board) consents, sample usage and downstream analytical results, is especially important in today's regulatory environment, which demands responsibility and accountability from researchers and research administrators to document and maintain audit trails of all use of human specimens for research.

• Schering AG (Berlin) will collaborate with Avid Radiopharmaceuticals (Philadelphia) to develop diagnostic imaging agents for Alzheimer's disease.

The compounds made by Avid directly bind to the amyloid plaques in the brain thought to cause Alzheimer's disease. They can be used with a variety of imaging technologies such as positron emission tomography (PET) scanning. The potential of this compound class to accumulate preferentially in brain structures of Alzheimer's patients with high amyloid beta load already has been demonstrated in pilot human studies, The companies said.

Schering will have the option to assume exclusive rights for the development and commercialization of such compounds for use with PET technology.