A Medical Device Daily

bioMérieux (Marcy l'Etoile, France) reported signing a license and development agreement with ProteoSys (Mainz, Germany) for Annexin 3, which will be used to develop a urine-based, confirmatory diagnostic test for prostate cancer.

After a research phase, the new test should be developed on the VIDAS platform, which is one of the most widely installed automated immunoassay instruments in the world.

Financial details of the agreement were not disclosed.

"It was an obvious choice to partner with bioMérieux because of its strategic focus on oncology, the market leadership of its VIDAS platform and its extensive commercial network," said André Schrattenholz, chief scientific officer of ProteoSys.

bioMérieux CEO Stéphane Bancel said, "We are ... pleased to work with ProteoSys to bring such an innovative biomarker to urologists around the world. This agreement is yet another building block in our high-medical-value test strategy."

Annexin 3, also known as ANXA 3, was discovered by ProteoSys. Studies have shown that ANXA 3 quantification in urine is a novel, non-invasive test with high specificity for prostate cancer. The ANXA 3 test is expected to be used to provide better identification of patients with a high probability of prostate cancer, thereby reducing the number of unnecessary biopsies.

The first phase of research is beginning at bioMérieux, which will be followed by the development of a diagnostic test for the VIDAS platform. While the confirmatory diagnostic application on VIDAS will be the initial focus, bioMérieux said it also is considering the development of treatment decision and prognostic applications for ANXA 3.

The ANXA 3 test will be complementary to the tPSA and FPSA tests available on the company's VIDAS platform.

CardioWest training for Italian hospital

Professor Francesco Musumeci, director of the cardiovascular department, cardiothoracic surgeon Antonio Loforte, MD, and the cardiac surgery team from Azienda Ospedaliera San Camillo Forlanini (Rome) completed the first phase of certification training for Syncardia's (Tucson, Arizona) CardioWest temporary Total Artificial Heart (TAH-t) in Berlin last month.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

Italy's first implant of the CardioWest artificial heart was performed in December 2007 at Azienda Ospedaliera di Padova in Padova. The patient was discharged from the hospital on the European portable driver on Feb. 4 and is at home while he waits for a matching donor heart.

The European portable driver received CE-mark approval in July 2006. "It allows stable CardioWest patients to recover at home while they wait for a donor heart," said SynCardia. "Discharge drivers allow stable artificial heart patients to shop, travel and enjoy a quality of life comparable to people with human hearts."

The company said it will submit an application to the FDA in 4Q08 to conduct an IDE clinical study of the Companion Driver System at 22 U.S. CardioWest certified centers. The Companion Driver is designed for use in both the hospital and for discharge.

Azienda Ospedaliera San Camillo Forlanini will become the 36th hospital in the world and the third in Italy to complete CardioWest certification training. The 270-bed Roman hospital performed 26 heart transplants last year and had performed 19 this year as of Aug. 31.

UK fellowships eye patient benefits

A new research fellowship program unveiled in the UK last month will provide £4 million in funding over the next three years for healthcare scientists to undertake research to improve patient services and treatment.

Funded by the UK Department of Health and supported by the National Institute for Health Research (NIHR), the effort will fund areas of research that will have direct patient benefit.

Research projects may include helping patients to self-care and self-manage, developing diagnostic tests, enhancing therapeutic services or improving the NHS's ability to monitor disease.

For this program, National Health Service scientists are invited to develop a research project that could both address a patient care issue and promote links between the NHS and university research groups.

Successful applicants will be selected by a panel, including representatives from the Department of Health, the NIHR and the NHS. Funding will be awarded for up to two years on a full-time or proportionate part-time basis.

Chief Scientific Officer Professor Sue Hill, who led the initiative, said, "These fellowships ... build on the aptitude and dedication of thousands of NHS healthcare scientists. I hope the new opportunities offered to them will help to support the research capabilities of NHS departments by further encouraging scientists to undertake translational research within health to improve care for patients."

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