A Diagnostics & Imaging Week

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.

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."

ISO, GMP okays for Hoana Medical

Hoana Medical (Honolulu, Hawaii) reported that it has completed the intensive regulatory audits for CAN ISO 13485 and the J-GMP, which allows the use of the CAN ISO and GMP marks for its LifeBed Patient Vigilance System and expands the company's patient safety reach to include Canada and Japan.

The ISO and J-GMP marks are similar to FDA clearance and the CE mark, which Hoana previously acquired for U.S. and European markets, respectively. These are mandatory regulatory approval systems for all medical devices to be sold in Canada and Japan, which indicates that a product conforms to the relevant health, safety and environmental quality standards in those countries.

Traditionally, obtaining CAN ISO and J-GMP mark certification and approval is a 12- to 18-month process, but Hoana completed the certification process in less than six months.

"Obtaining the CAN ISO and J-GMP marks for the LifeBed Patient Vigilance System is another giant step toward bringing cutting-edge patient safety technology to countries with which we have close economic ties," said Hoana CEO Dr. Patrick Sullivan.

He added, "We have received tremendous interest in the LifeBed from hospitals in both Canada and Japan and will now be able to work with them to not only meet Joint Commission International's patient safety goals, but also improve healthcare. Patient safety is an international issue facing citizens of every country."

In Canada, a study showed that one in nine Canadians were victims of preventable medical errors and more than 24,000 people die each year from medical mistakes. In Japan, medical error figures are harder to come by because of the administrative reporting requirements and cultural barriers.

Medical errors in Japan are prosecutable in the criminal courts vs. the civil courts in the U.S., leading to fewer reported cases. Hoana said the government has acknowledged the need for dramatic improvements in patient safety and the need to find technological solutions on that front.

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