A Medical Device Daily

deCode genetics (Reykjavik, Iceland) and Ilumina (San Diego) reported the formation of an alliance under which the companies plan to co-develop and commercialize DNA-based diagnostic tests in several major disease areas.

The alliance will employ Illumina's platform for high-multiplex single- nucleotide polymorphism (SNP) genotyping to develop tests for gene variants deCode has previously shown to have impact on the risk of a growing number of common diseases with major public health impact.

Illumina will gain access to disease- related biomarkers for joint validation as diagnostic panels to be marketed and sold by Illumina on its forthcoming BeadXpress platform. The companies will share development costs and split the profits from sales of the diagnostics tests.

The alliance will initially focus on the development, validation and commercialization of specific diagnostic tests for variants in genes involved in three disease-related pathways:

  • The gene-encoding leukotriene A4 hydrolase, linked to heart attacks.
  • The gene-encoding transcription factor 7-like 2 (TCF7L2), linked to Type 2 diabetes.
  • The gene-encoding BARD1, linked to breast cancer.

Illumina will install its SNP genotyping platform at deCode, enabling deCode to expand its contract genotyping business to offer Illumina platform and assay technologies together with deCode's proprietary analytical services for customers.

deCode will use the Illumina platform to carry out high-density, whole-genome studies utilizing its comprehensive population genetics resources in Iceland, including more than 100,000 participants in some 50 common diseases.

In other agreements news:

• Active Data Services (Morrisville, North Carolina), a business process outsourcing firm, reported that it has formed a strategic agreement with Misys Healthcare Systems (Raleigh, North Carolina), which focuses on healthcare IT, to provide electronic healthcare data services including integrated medical document conversion and strategic capture services. The partnership will integrate existing healthcare data for use with Misys' software solutions to improve efficiency and ease of use for healthcare organizations.

• Response Biomedical (Vancouver, British Columbia) and Shionogi & Co. . reported that the companies have entered into a marketing and supply agreement to commercialize a rapid quantitative RAMP test in Japan for BNP (B-type natriuretic peptide), a cardiac marker test to assist in the diagnosis and management of congestive heart failure.

The companies also said that the RAMP test for BNP received regulatory approval in Japan, allowing for its immediate market launch in that country.

With exclusive rights to BNP diagnostics in Japan, Shionogi funded the development of the BNP test on Response Biomedical's RAMP platform and secured Japanese regulatory clearance. Shionogi will market the clinical point-of-care diagnostic system, manufactured exclusively by Response Biomedical, both directly as well as through its own network of distribution partners under the trademark Shionospot BNP.

“RAMP's correlation with Shionogi's lab-based test for this important congestive heart failure marker will position it well for commercial launch,” said Bill Radvak, president and CEO of Response Biomedical. “The RAMP BNP test is the only rapid, point-of-care product commercially available in Japan and has the potential to enjoy considerable market adoption.”

• Nanogen (San Diego) reported a collaboration agreement with Oy Jurilab , a Finnish genomics company. The collaboration is designed to identify and validate new prognostic markers for Type 2 diabetes.

“There are 20 million children and adults living with diabetes in the U.S., and many of them are undiagnosed until they develop complications,” said Howard Birndorf, Nanogen chairman and CEO. “Combining genetic data about risk with early intervention strategies can have a significant impact on reducing disease incidence and severity, and we expect to see extensive demand for prognostic and diagnostic tests, as well as for new effective drugs.”

Jurilab has access to genetic screening of an isolated population in East Finland, which is derived from one of the most genetically homogeneous populations available. Estimated at approximately 20 generations old, it is about half the age of other populations employed in screening programs, the companies said. Fewer generations result in less genetic variation, and statistically significant data can be derived from relatively small sample groups, reducing research time and costs.

Through the current agreement, Nanogen will gain access to markers identified by Jurilab in genome-wide screens.