A Medical Device Daily

CryoLife (Kennesaw, Georgia), a biomaterials and tissue processing company, has entered an agreement with the Cleveland Clinic (Cleveland, Ohio) to develop an allograft, or human tissue, heart valve for patients suffering from heart infections.

The organizations will collaborate on developing a combination aortic/mitral allograft heart valve for patients with infective endocarditis, a condition in which the structures of the heart, particularly the heart valves, are infected.

Jose Navia, MD, a cardiac surgeon with the Heart and Vascular Institute at Cleveland Clinic, will work with CryoLife to develop the methods to process the valve. Navia has filed U.S. patent applications for the tissue preparation method and valve implantation techniques.

“Patients who develop infective endocarditis of both the native mitral and aortic valves are at particularly high risk for morbidity and death stemming from this infection,” said Navia. “Current heart valve replacements for these patients include a high percentage of synthetic materials, which are more prone to harboring infection. The combination aortic-mitral allograft heart valve may potentially provide a more infection-resistant treatment option.”

In other agreement news:

• Illumina (San Diego) and Mayo Clinic (Rochester, Minnesota) said they have signed a diagnostic collaborative agreement for the co-development of molecular diagnostic tests for the study of complex diseases.

Illumina will contribute its VeraCode technology and development expertise for the BeadArray and BeadXpress instrument platforms. Mayo will provide its knowledge in clinical practice and patient outcome management, along with proficiency in establishing clinical utility of new diagnostic technologies. In addition, Mayo’s ability to discover and validate biomarkers offers the potential for both parties to implement important new clinical tests, the organizations said.

Terms of the agreement enable the implementation of new clinical tests within Mayo’s clinical practice and Mayo Medical Laboratories. Additionally, Illumina will manufacture and market tests worldwide on its BeadArray and upcoming BeadXpress Reader.

• diaDexus (South San Francisco), a privately held biotechnology company, reported a collaboration with Mayo Validation Support Services of the Mayo Clinic (Rochester, Minnesota) to investigate a test featuring a select panel of tumor-specific genes to aid in patient risk stratification and assist in chemotherapy treatment decisions for breast cancer patients. The test uses gene expression profiling to predict recurrence of malignancy in patients diagnosed with primary invasive early stage breast cancer.

Previous study data presented by diaDexus at the 2005 San Antonio Breast Cancer Symposium demonstrated that a set of eight genes were differentially expressed in patients who presented with progressive disease, compared with those who were disease-free after a median follow-up of 70 months, suggesting that the PCR-based test involving these genes warrants additional investigation into its utility in identifying patients at higher risk for recurrence.

The Mayo collaboration is part of diaDexus’ molecular diagnostics program focused on developing tests to aid in the prognosis and staging of breast, colorectal, and prostate cancers.

• eGene (Irvine, California), developer of a genetic analysis technology, reported that it has entered into a distribution agreement with Fisher Scientific, Canada, part of Thermo Fisher Scientific (Waltham, Massachusetts), to promote and sell eGene’s HDA-GT12 system in Canada.

Thermo Fisher focuses on providing analytical instruments, equipment, reagents and consumables, software and services for research, analysis, discovery and diagnostics.

eGene focuses its core technologies of capillary electrophoresis, microfluidics, liquid handling and automation to develop and manufacture low-cost microfluidic, miniaturized digital genetic analyzer systems, software and consumables for biological materials testing applications.

The products are designed to detect, quantify, identify and characterize DNA and RNA at high rates of specificity and sensitivity while automating routine and non-routine laboratory and industrial procedures critical to product safety, development quality and productivity, the company said.

• Iris International (Chatsworth, California) reported that its Iris Diagnostics division has entered into a sales and service supply agreement with the Sisters of Mercy Health System (St. Louis) that began Dec. 1.

The two-year agreement has two optional extension years after Nov. 30, 2008.

The Iris Diagnostics division will supply to the Sisters of Mercy Health System’s GPO its iQ200 Series units, the iQ Body Fluids Module, its AX-4280 Automated Urine Chemistry Analyzer units, its iChem100 Urine Chemistry test strips, and all consumables and supplies, to be complemented with annual service agreements and training.

IRIS focuses on automated urinalysis technology with systems in major medical institutions throughout the world.

• NxStage Medical (Lawrence, Massachusetts) reported signing long-term agreements with two existing suppliers to secure supply to meet the growing demand for its NxStage System One portable kidney dialysis system.

The first agreement calls for Medisystems (Seattle) to continue providing disposable cartridges for the next seven years. Membrana (Wuppertal, Germany), a subsidiary of Polypore (Charlotte, North Carolina), will continue to supply PUREMA capillary membrane for filters used with the NxStage System One over a 10-year period.

The NxStage System One is the first portable hemodialysis system cleared for home use by the FDA, the company said.