A Medical Device Daily

Biosite (San Diego) and Oxford Genome Sciences (OGeS; Oxford, UK) reported forming a collaboration to evaluate protein-based disease markers for colorectal cancer for the development of blood-based tests. The tests would be aimed at providing, the companies said, “personalized” therapeutic options for colorectal cancer.

In particular, the blood-based diagnostics would enable early identification of colorectal cancer patients that have relapsed, thus enabling selection of the most appropriate therapies.

The fecal occult blood test and colonoscopy, a highly invasive procedure, are the most frequently used screening and diagnostic methods for colorectal cancer, which has a 30% to 40% recurrence rate within an average of 18 months after first diagnosis.

OGeS has developed the Oxford Genome Anatomy Project (OGAP), a database that integrates genomic, proteomic and clinical information derived from blood and tissue studies. In the collaboration, OGeS will identify at least 25 proteins discovered in blood and tissue samples from relapsing colorectal cancer patients, with Biosite having the rights to develop blood-based tests using one or more of those biomarkers. Financial terms of the agreement were not disclosed.

Kim Blickenstaff, Biosite CEO, said that the collaboration “expands our research aimed at evaluation of diagnostic tools for relapsing colorectal cancer by providing us with access to high quality validation of potentially valuable protein biomarkers.”

Christian Rohlff, OGeS CEO, said, “Relapsing disease is the major cause of suffering and death in colorectal cancer patients and there is a complete lack of clinical tools to aid physicians in the process of deciding whom to treat when and whether to treat with chemotherapy.”

RITA, Biocompatibles in bead accord

RITA Medical Systems (Fremont, California) reported the signing of an exclusive three-year supply and distribution agreement with Biocompatibles International (Barnham, UK) to market its LC Bead embolization product in the U.S. and Canada.

The product is designed as a minimally invasive treatment for hypervascular tumors. The LC Bead is used as the embolic component of a procedure known as trans-arterial chemo-embolization (TACE). TACE has been demonstrated in clinical trials to reduce the size of liver tumors, enabling some patients to receive further treatment with surgery, RFA or a curative liver transplantation. TACE is used in the treatment of hypervascular tumors, including certain liver tumors, and combines tumor-directed chemotherapy with embolization therapy.

During a TACE procedure, a chemotherapy drug is mixed with an embolization agent like the LC-Bead. The mixture is injected into the blood vessels feeding the tumor. TACE aims to reduce the blood supply to the tumor while simultaneously delivering a high local dose of chemotherapy.

RITA said it believes that the total potential U.S. and Canadian market for all embolization products may be up to $50 million annually, based on the use of embolization in primary liver cancer patients. RITA currently expects to begin shipments of the LC Bead in the third quarter of 2006.

“We believe the LC Bead is the technology of choice in this emerging field of medicine,” said Joseph DeVivo, president and CEO of RITA Medical. “This minimally invasive treatment for cancer fits closely with our existing product offerings and with our position as an outstanding medical device oncology company providing real value to doctors and their patients.”

The LC Bead is FDA-cleared for use in embolization of hypervascular tumors and arteriovenous malformation. The product will be distributed by RITA from its U.S. operations center in Manchester, Georgia.

5D launches blood products software in Europe

5D Information Management (Alberta, Canada), a business of Haemonetics (Braintree, Massachusetts), reported the launch of two new software products into the European blood collection market. The software systems are designed to improve the blood donation experience and improve operating efficiency for blood collection centers.

eQue Automated Interview and Assessment, the company's first product, is a self-administered donor registration system, health history questionnaire and assessment tool to assist blood blanks and plasma centers in determining a person's eligibility to donate blood. eQue provides an interface with touch screen technology, audio and visual prompts, and multi-lingual capabilities. Once registered, the donor completes the health history questionnaire, and then eQue provides staff with all required information for the center to determine donor eligibility. The “smart” electronic questionnaire shortens the registration process, with improved accuracy.

The second product, eLynx Donor Floor Automation, automates donation floor operations by eliminating the need for much of the paperwork in both blood banks and plasma centers. eLynx electronically captures real-time information on the donor floor. The system can be used for whole blood and apheresis collections.

Peter Allen, president of Haemonetics' Donor Division, said, “eQue and eLynx are key pieces of our vision for total blood management. As we leverage our leadership position in blood processing, we will continue to bring to market innovative products like eQue and eLynx to market to support our customers' desire for products that ensure good manufacturing practices and the safety of the global blood supply.”

5D develops regulated information technology solutions and delivers hosting, support and consulting services to the blood collection market.