A Diagnostics & Imaging Week

Agendia's (Amsterdam, the Netherlands) MammaPrint microarray test has been registered as a medical device at the Dutch Healthcare Inspectorate, which enables Mamma-Print to bear the CE mark.

The MammaPrint gene expression service uses a 70-gene profile to classify breast cancer patients as "low" or "high" risk of developing distant metastasis in a 10-year period. MammaPrint therefore offers additional information to oncologists and patients concerning the subsequent treatment plan.

Agendia said that several studies in institutes and hospitals in Europe and the U.S. have demonstrated that MammaPrint outperforms conventional classifying methods such as the widely used St. Gallen criteria.

The company said it is in the process of acquiring the Medical Device registration for other genetic profile-based tests, including CupPrint. That test is intended for cancer of unknown primary origin patients, which Agendia said represents around 5% of all the types of cancer and for which the diagnosis and therefore, adequate treatment, is difficult by conventional techniques. That sometimes results in high rates of toxic deaths caused by chemotherapy, it said.

The company said the CUP test identifies the primary tumor reliably, which allows the patient to be correctly treated.

A leader in gene expression analysis-based diagnostics, Agendia is focused on the development and commercialization of diagnostic tests using tumor gene expression profiling. A spin-off of the Netherlands Cancer Institute, the company has a strong base in cancer research, ensuring access to the latest developments in that area.

In addition to developing new cancer diagnostics, Agendia offers its expertise in finding new prospective gene expression profiles to companies focusing on new drug development in the area of oncology.

Kodak a key supplier to RATU project

Eastman Kodak's (Rochester, New York) Health Group has been selected as the main supplier of the RATU e-health project in Northern Finland. The extensive project is funded by five hospital districts and the Finnish Ministry of Social Affairs and Health (Helsinki).

The RATU project is a pilot project for the country, aiming at creating a total solution for the five hospital districts for the production, processing and archiving of patient information. The Northern region's entire image, biosignal and text data of patients is stored in a central archive. The project is seen as an important step toward establishment of a national patient record archive.

With the RATU project, the hospital districts' appointment bookings, consultations and X-rays can be transferred using a centralized system. The first phase of the project is to be completed during 1Q06, when all the Northern region's central hospitals and four pilot healthcare centers will be connected.

Kodak will provide a community radiology solution that includes Kodak RIS 2010, Kodak DirectView PACS System 5 web clients and a Kodak Carestream Information Manage-ment Solution powered by Kodak Versatile Intelligent Patient Archive (VIParchive) software to efficiently manage medical images and related patient information.

The company is the software and systems delivery supplier of the 2.7 MEUR project. Systems integration is carried out by Mawell Ltd., a Finnish IT company.

With the new system, participating hospitals – and later all healthcare centers that join the initiative – will be able to store, download and view patient images regardless of location. In addition, the Lausuntotori portal will enable inter-regional delivery and consultation of X-ray images over the Internet.

"RATU is the largest e-health project in the Nordic countries on a geographical scale," said Pekka H nnik inen, country sales manager of Kodak's Health Group. "It combines the functionality of the hospital regions' information systems, improving healthcare information sharing across traditional borders, thus speeding up the whole treatment process."

The Lappi Hospital District originated the predecessor of RATU in 1997. The RATU includes the hospital districts of Lappi, L nsi-Pohja, Pohjois-Pohjanmaa and Keski-Pohjanmaa, as well as Kainuu County. The region consists of 69 healthcare centers and will produce more than 700,000 exams annually with more than 8,000 registered web users and 1,000 concurrent users.

Patent issued for Lymphoseek

Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that the University of California, San Diego (UCSD) has received notification regarding the acceptance by countries representing the major markets in the European Union of the first patent covering Lymphoseek.

It said the claims covered by the patent issued in the EU are consistent with the claims covered by U.S. patent No. 6,419,990, issued to UCSD in June 2002.

Neoprobe holds the exclusive rights to Lymphoseek under license from UCSD for diagnostic use in applications such as lymphatic mapping as well as in ultrasound and optical imaging. Lymphoseek is being initially developed as a lymphatic tissue-targeting agent to improve the ability of physicians to more quickly and more accurately indicate the spread of such cancers as breast cancer and melanoma.

These products trace, or map, the lymphatic patterns in cancer patients to evaluate potential tumor drainage and cancer spread, often eliminating or reducing the need for surgical removal of lymphatic tissue.

Neoprobe said clinical studies have indicated that lymphatic mapping is approximately 97% accurate in predicting the presence or absence of disease spread in mela-noma or breast cancers. Consequently, it is estimated that more than 70% to 75% of women who would otherwise have undergone full axillary lymph node dissections, involving the removal of as many as 20 to 30 lymph nodes, might have been spared this radical surgical procedure if the sentinel node was found to have been free of cancer.

Fonar 360 installation under way

Fonar (Melville, New York) has reported that installation in the UK for the first of its room-size MR imaging units, the Fonar 360, where it will commence clinical trials to develop image-guided surgical procedures known as intraoperative MRI.

The room-size MR imaging unit will be housed in the Nuffield Orthopaedic Centre (Oxford) in a recent-ly completed facility specially built for this project.

Fonar said that the Fonar 360 system will be the centerpiece of what will be the world's first room-size MRI scanner in which surgeons and radiologists will have full 360-degree physical access to the patient for performing MRI guided surgical procedures.

First applications in the trial will be orthopedic MRI and the development of MRI-guided intraoperative techniques for surgery of the spine and other orthopedic structures.

Diagnostics Products in NT-proBNP launch

Diagnostic Products Corp. (DPC; Los Angeles) re-ported release outside the U.S of its assay for N-terminal prohormone brain natriuretic peptide (NT-proBNP), a diagnostic marker of congestive heart failure (CHF) and a prognostic marker of CHF and acute coronary syndromes (ACS).

The assay has received CE marking and is now available immediately on DPC's Immulite 2000 and Immulite 2500 immunoassay systems.

CEO Michael Ziering said, "Labs using the Immulite 2500 can now return 15-minute results for NT-proBNP as well as for the other STAT cardiac assays we offer – troponin I, CK-MB and myoglobin – without splitting samples. The lab's productivity benefits by performing STATs along with our extensive menu of routine, esoteric and allergy immunoassays on the same system."