A Diagnostics & Imaging Week

Agendia (Amsterdam, the Netherlands) and Arcturus (Mountain View, California) have signed a license agreement under which Agendia has obtained the exclusive European rights to the TUO (Tumor of Unknown Origin) gene expression profile discovered by Arcturus.

Using this profile, Agendia has developed CupPrint, a gene expression-based diagnostic test to be used with patients diagnosed with Cancer of Unknown Primary (CUP).

Financial details of the agreement were not disclosed.

The potential of CupPrint was presented by Ren Bernards, PhD, Agendia's co-founder and chief scientific officer, during last week's American Association for Cancer Research Oncogenomics conference in San Diego.

Cancer of Unknown Primary (CUP), also known as UPT (Unknown Primary Tumor) or TUO, is diagnosed when distant metastasis is discovered in a patient, but the primary tumor is unknown. CUP accounts for 5% to 10% of all new cancer referrals and is the fourth-most-common cause of cancer mortality.

Generally, CUP patients face a poor prognosis, with mean survival rates of six to nine months. However, identification of the primary tumor enables specifically targeted clinical treatment, which Agendia said "markedly enhances the chances of success."

CupPrint is a gene expression profiling service that the Dutch firm describes as offering "an alternative to conventional cancer diagnostics." CupPrint uses a continuously expanding gene expression database that currently includes 32 different tissue types and 78 tumor types.

According to Agendia, it can rapidly determine whether the primary tumor belongs to one of the major categories. If so, the company said "treatment can be specifically gear-ed to the patient's needs, offering a major improvement in the clinical results and the patient's prognosis."

The service is expected to be available by early spring of this year.

Bernhard Sixt, Agendia's CEO, said adding CupPrint to the company's portfolio underlines its strategy to provide new and better cancer diagnostics. "Our aim is to develop products that assist oncologists and physicians to determine who should be treated in which specific way," Sixt said. "Targeted, tailor-made clinical treatments plans are essential in maximizing a patient's chances of a cure."

Robert Schueren, executive vice president and chief operating officer of Arcturus, hailed Agendia for developing his firm's TUO-gene expression profile into an application available to European oncologists and patients. "Agendia is the world's first provider of a cancer diagnostic service based on DNA microarray technology MammaPrint. We are pleased to partner with [them] to employ our TUO-profile in their new diagnostic service." Agendia's MammaPrint prognostic test predicts the chance of breast cancer recurrence.

The privately held company is a spin-off of the Netherlands Cancer Institute. In addition to the development of new cancer diagnostics, the company offers its expertise in finding new prospective gene expression profiles to companies focusing on oncology drug development.

Two new distributors for DOBI

DOBI Medical International (Mahwah, New Jersey) reported another step in its continued expansion into international markets with the signing of new distributor agreements in Brazil and the Netherlands.

Advanced Imaging (Sao Paulo, Brazil) and Tromp Medical Engineering (Castricum, the Netherlands) each will conduct a clinical trial using the company's ComfortScan system to aid in obtaining local approvals specific to their respective regions.

The ComfortScan system is a light-based, noninvasive and gentle dynamic optical imaging device designed to assist physicians in the diagnosis and management of breast cancer.

With the addition of these two distributors, the DOBI Medical's global distribution network now has nine distributors representing 13 countries, including Canada, Costa Rica, Columbia, the Czech Republic, Greece, India, Liechtenstein, Nicaragua, Panama, Russia and Switzerland.

The company said it expects to sign additional distribution agreements in 2005 as it continues to expand its international network.

DOBI said that according to the European Network of Cancer Registries, breast cancer is the most common cancer in females in Europe. While the incidence of breast cancer is rising among women in many European countries, the Netherlands currently has the highest incidence of breast cancer in Europe.

The incidence of breast cancer also is now more common in South America, with Brazil having the highest number of breast cancer cases in that region, as reported by the International Agency for Research on Cancer.

"Advanced Imaging and Tromp Medical Engineering . . . have excellent reputations as leading medical suppliers with- in their respective countries," said Denis O'Connor, senior vice president of marketing, sales and service at DOBI.

He added: "After successful completion of the clinical trials, we expect the ComfortScan system to be available for commercial sale in Brazil and the Netherlands."

O'Connor said these newest agreements further strengthen his company's global distribution network, "and reflect the growing medical need for the ComfortScan technology throughout the world."

UK pushes medical practice/patient safety review

The UK government is undertaking a review into patient safety in a move intended to help protect patients from poor medical practice and misconduct. The review, which is part of the Department of Health's response to the Shipman Inquiry into patient safety, is being led by England's chief medical officer, Sir Liam Donaldson.

Donaldson is charged with making his report on the Department of Health's patient protection measures later this year in order to minimize any delay in the introduction of measures to improve patient safety and ensure that physicians are fit to practice.

Trading begins for Biofusion

Biofusion (Sheffield, UK) began trading recently following its initial public offering on London's Alternative Investment Market, raising 8.2 million ($17.8 million).

The technology commercialization company has a 10-year exclusive deal to commercialize biological and medical research from Sheffield University.

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