Diagnostics & Imaging Week Contributing Writer
And D&IWs

The holding company for British Biocell International (BBI; Cardiff, UK), a developer and manufacturer of rapid result diagnostic tests, acquired the rights to the D-dimer tests of Agenix (Brisbane, Australia) and said it plans to take this chemistry for point-of-care (POC) diagnostics to a new level through a proprietary platform for next-generation rapid-test diagnostics.

In addition to the product rights, purchased for A$2.7 million ($2.11 million), BBI Holdings (Cardiff) acquired plant equipment and existing stock and inventory for another A$1.2 million ($940,000).

BBI said it would install the production line at its recently acquired facility in Dundee, Scotland. Agenix will support the manufacture of the product through this transfer process, which is expected to take up to a year. Financing came from cash resources and a loan for £1.3 million ($2.5 million), BBI reported in a statement.

The agreement includes the Simplify and SimpliRED range of D-dimer diagnostic products, distributed exclusively by Inverness Medical Professional Diagnostics (Waltham, Massachusetts), as well as two diagnostics to detect fibrin degradation products, a process essential in rapid diagnosis tests of deep vein thrombosis, pulmonary embolism and disseminated intravascular coagulation.

Julian Baines, managing director of BBI, said, "The deal with Agenix will diversify our range. Not only are we moving up the value chain with a unique product, but the equipment that we will acquire will bring a higher level of automation to BBI, strengthening our manufacturing services." In addition to its own product line, BBI is a contract manufacturer for leading medical device manufacturers, including Merck (Darmstadt, Germany).

Two days after announcing the agreement, BBI reported a 50/50 joint venture with precision plastics manufacturer Carclo (West Yorkshire, UK) for acquiring Platform Diagnostics (Liverpool, UK), a developer of POC diagnostics with four patents covering its capillary agglutination technologies (CAT) used to adapt standard diagnostic testing to lower-cost, disposable, "digital" test units. Compared to sandwich immunoassays currently available that require a yes-no, or qualitative result, the digital signal generated by CAT will include quantitative results.

"We look forward to taking the D-dimer test to a new level through this collaboration with Platform," said Baines. The Agenix line will be the first development target for the patented capillary system developed by Platform, he said.

The second focus will be a new format of lateral flow currently in development and awaiting the results of feasibility studies.

Ian Williamson, chief executive for Carclo, said the CAT platform, "combined with BBI's newly acquired D-dimer chemistry, is an ideal opportunity to bring to market a new generation of low cost, rapid diagnostic tests for the point-of-care market."

Reporting a "much-improved balance sheet," Carclo said last year that it intended to move aggressively into medical diagnostics to expand upon its traditional base in automotive, electronics and aerospace.

The main division, Carclo Technical Plastics, accounted for two-thirds of 2006 sales of £90 million ($173 million) and has developed an expertise in microfluidics, surface coatings and optics. The division produces lateral flow cassettes, reaction test kits and immunoassay test cartridges, as well as laboratory disposables.

The partners said they expect to complete the development of the first products using the Platform technology within the next 12 to 18 months.

Meanwhile, BBI in January upgraded its financial support as a "business angel" for Quotient Diagnostics (Surrey, UK), developer of a near-to-patient diabetes test for A1c, a fraction of the blood protein hemoglobin.

The three-minute test is performed in a small disposable cartridge that is then inserted into a reader to detect changes of fluorescence in the reagent and convert the resulting signal into a readable displayed for patient care staff.

Quotient is currently conducting clinical studies as part of a 510(k) submission in the U.S. and CE-mark submission in Europe.

Kodak gets Canadian nod for CR system

Eastman Kodak (Rochester, New York) said it has obtained Health Canada approval for its computed radiography (CR) system for mammography and will immediately begin selling the system in that country.

The Kodak Directview CR Mammography Feature enables mammography images to be captured digitally while using a health provider's existing mammography X-ray unit. The optional feature is available when purchasing a high-productivity Directview CR 850 or CR 975 system or as a retrofit to currently installed CR 850/950/975 systems.

Dina Vazzana, general manager, mammography solutions, for Kodak's Health Group, said, "Computed radiography enables medical facilities to benefit from the latest digital technology in a cost-effective manner that complements their existing departmental workflow structure."

The company's CR for mammography feature has been selling in Europe, Asia, Japan and Latin America for more than 18 months. Kodak has installed hundreds of systems with the feature in facilities such as clinics, breast imaging centers and hospitals.

Kodak recently entered into an agreement to sell its Health Group to a subsidiary of Onex (Toronto). With consolidated revenues of almost $20 billion, Onex, which owns companies in a range of industries, has a growing group of healthcare companies.

It is anticipated that the sale will close in the first half of this year, at which time the Health Group will become a stand-alone company that will operate brand-named Carestream Health.

Biomoda, Cureline eye licensing deal

Biomoda (Albuquerque, New Mexico), a maker of early lung cancer detection testing and other cancer diagnostic technology, reported negotiations with Cureline (San Francisco), a biomedical sample management company, to license Biomoda's diagnostic technology for sale in Russia, Eastern Europe and Asia.

Cureline, founded in 2003 by scientists and business development experts as a custom tissue-procurement organization, is primarily involved in pre-clinical and clinical research management services, with an emphasis on medical samples acquisition, biomarkers discovery and co-development of diagnostic tests in oncology.

"Biomoda is in the process of further aligning itself with this dynamic partner to open up an important market for [our] patented diagnostic technology," said John Cousins, president of Biomoda.

"Cureline is very interested in developing a clinical laboratory business in Russia, Eastern Europe and Asia, where we already have been conducting business for the past three years," said Olga Potapova, PhD, that company's president and scientific director.

The Mayo Clinic (Rochester, Minnesota) and Biomoda are jointly conducting a broad validation study of the company's technology, a non-invasive, cytology-based lung cancer diagnostic assay.

The technology is based on a patented porphyrin application that preferentially binds to cancerous or aberrant cells extracted from lung sputum samples. Cancerous cells glow red under fluorescent light to allow detection under a microscope. The technology is designed for cancer screening of large populations at an early stage.

The five-year survival rate for lung cancer cases detected when the disease is still localized is 50%. At present, only 16% of lung cancer cases are diagnosed at this early stage, Biomoda said.

Production plagues Guerbet profitability

A specialist in patient-consumable medical imaging contrast agents, Guerbet (Paris) blamed an 18% drop in 2006 profitability on "production incidents that are now resolved." The company reported a sales increase of 7.4% for total 2006 revenues of 1289 million ($390 million) and net income of almost 119 million ($26 million).

The company's production problems, which it declined to specify, resulted in sharply increased manufacturing costs for the second half of the year. Continued production investments are expected for 2007.

Guerbet provides contrast agents for X-ray imaging and MRI, including Xenetix for whole-body imaging; Dotarem, a gadoteric acid for MRI imaging; and Imagenil for intra-arterial and intravenous indications in conventional radiology and CT scanning.

Agence Option Finance reported that Guerbet saw sales increase 5.1% for Xenetix and 8.6% for Dotarem in 2006. While European sales "kept pace with the market" at 2.3%, the company reported sales in Asia increased nearly 38% year-to-year and by 18% in Latin America.

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