A Medical Device Daily

Guardian Technologies International (Herndon, Virginia) reported yesterday that the Medical Imaging and Informatics Laboratory at the University of California (USC; Los Angeles) has extended its collaboration agreement with the company to further validate the real world application of Signature Mapping and to develop a prototype that will serve as a model for future use by radiologists.

Clinical evaluation and initial prototype development will be led by H.K. Huang, PhD, professor of radiology and biomedical engineering at USC. Huang and his team will be evaluating feedback provided by radiologists regarding potential enhancements to Signature Mapping visualization tools and integration methodology as it applies to medical radiological imaging workflow.

Guardian and USC will collaborate on three areas: breast imaging and breast cancer research; chest imaging and tuberculosis detection and monitoring; and traumatic brain injury and acute intracranial brain hemorrhaging.

Focusing on breast imaging and breast cancer detection, USC will provide continued analytical validation of Signature Mapping as it relates to the recently announced success from the South Florida mammography database. USC will also focus on the development and evaluation of a clinical prototype for use in mammography for the visualization of breast cancer and study the integrated use of MRI and mammography as an effective screening and diagnostic tool.

USC will also support the development and evaluation of a prototype for use in screening, monitoring and staging after the detection of tuberculosis. USC's clinical focus will be on chest X-rays, either from direct digital or scanned film.

Furthermore, USC will apply its efforts towards Signature Mapping's application to acute traumatic brain injury with the development and evaluation of a prototype for use in detection and quantification of acute intracranial hemorrhage, with primary deployment on CT scanners. USC will also assess how the current work in multiple sclerosis and normal pressure hydrocephalus can be used for patient screening and evaluation in traumatic brain injury work that was jointly conducted last year.

Guardian said it has already undertaken development and clinical evaluation on challenges ranging from more precise and earlier detection of breast and prostate cancer. It said that research has also proven that Signature Mapping can automatically detect intracranial hemorrhagic associated with traumatic brain injuries using CTs, and can locate and quantify multiple sclerosis lesions in MRIs, as well as the extent of tuberculosis, pneumoconiosis, and even cancer in the lungs using commonly available and inexpensive chest X-rays.

Guardian develops medical imaging and threat detection technology with applications for the healthcare and homeland security markets.

In other agreement activity:

• Iris International (Chatsworth, California) and Amerinet (St. Louis) reported that they have entered into a three-year sales and service supply agreement for the first time for the entire Iris urinalysis product line.

Iris Diagnostics will supply Amerinet and its member organizations with the full array of Iris urinalysis products, including the iQ 200 Series urine microscopy analyzers, the iChem 100 semi-automated urine chemistry analyzers, the iQ body fluids modules, along with consumables and service contracts.

"This is a comprehensive supply agreement for sales and services with one of the largest GPOs in the country, opening a new sales channel which gives us access to more than 2,100 acute care facilities and more than 20,000 non-acute care facilities in the Amerinet network," said César García president/CEO of Iris. "This latest agreement, when combined with our other existing GPO agreements, provides Iris entré to more than 75% of hospitals nationwide."

Amerinet strategically partners with healthcare providers to improve operating margins by creating efficiencies, reducing costs and identifying new revenue streams.

Iris International is a developer, of medical devices, diagnostic systems and consumables.

• Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, reported it has signed a multi-year enterprise agreement with ICON (North Whales, Pennsylvania). Earlier this year, the two companies reported that ICON had joined Phase Forward's CRO advantage program.

In part, the new agreement gives ICON the option to adopt the InForm integrated trial management (ITM) electronic data capture (EDC) platform internally and as such offer the benefits InForm affords under a fully hosted model. Customers will now have the option of working with ICON on clinical studies where ICON is developing, managing and hosting the InForm software, or alternatively, ICON customers can work with Phase Forward under a hosted model. Under a hosted model, the company said it offers services, support, technology and training to help customers ease into adoption within a desired time frame.

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

Phase Forward is a provider of integrated data management solutions for clinical trials and drug safety.

Siemens Medical Solutions Diagnostics (Tarrytown, New York) reported that it has been selected by Amerinet, (St. Louis) to provide a complete line of immunoassay, chemistry, and automation solutions.