American Association for Clinical Chemistry
Better health through laboratory medicine
January 2008 Clinical Laboratory News: Industry Profiles

 January 2008: Volume 34, Number 1

Genzyme to Acquire Diagnostic Division of DCL

Genzyme (Cambridge, Mass.) announced an agreement to acquire the diagnostic division of privately-held Diagnostic Chemicals Limited (DCL, Charlottetown, Prince Edward Island), a business that includes a line of more than 50 formulated clinical chemistry reagents as well as research and manufacturing operations in Prince Edward Island and Connecticut facilities. The agreement leaves out BioVectra, DCL’s bio-pharma division. “This acquisition is a strong strategic fit with our diagnostic business that gives us the opportunity to reshape our formulated reagents product portfolio,” said Donald E. Pogorzelski, president of Genzyme Diagnostics. “This transaction significantly expands and complements our product offerings and will also strengthen our commercial, operational, and research and development infrastructure.”

Beckman Coulter Licenses Technology for Sepsis Assay, Completes NexGen Acquisition

Beckman Coulter (Fullerton, Calif.) announced an exclusive agreement to license patents and intellectual property for Critical Therapeutics’ (Lexington, Mass.) proprietary High Mobility Group Box Protein 1 (HMGB1), which belongs to the pro-inflammatory cytokines class of proteins. Beckman Coulter intends to use HMGB1 to develop an immunoassay for detection and management of inflammatory diseases, starting with sepsis. According to the company, HMGB1 levels are also linked to other chronic inflammatory diseases such as rheumatoid arthritis. “The addition of HMGB1 puts us in a leading position with proprietary markers for the diagnosis and management of sepsis,” said Mike Whelan, VP of Beckman Coulter’s immunoassays and nucleic acid testing business center. Under the licensing agreement, Critical Therapeutics will receive an undisclosed license fee, as well as potential future royalties contingent on sales of the test Beckman is developing.

Beckman Coulter also announced that it will acquire the remainder of NexGen Diagnostics, a Lumigen spin-off. Beckman bought Lumigen in 2006. NexGen’s assets are primarily intellectual property related to a proprietary non-separation immunoassay technique that can eliminate steps but maintain high sensitivity.

Luminex and Mayo Clinic Ink Deal for Genetic Testing

Luminex (Austin, Texas) announced a licensing deal whereby Mayo Clinic (Rochester, Minn.) will provide genetic and other testing services using Luminex’s xMAP technology. The agreement provides for collaboration and licensing for the inherited disorder thalassemia, as well as other tests. Mayo Clinic said it plans to enhance its current genetic testing services for thalassemia with a new molecular diagnostic test based on multiiplex ligation-dependent probe amplification (MLPA) and bead-based liquid micro-array technology using the xMAP technology from Luminex. According to Mayo Clinic, the new technique will benefit patients by including detection, cutting turnaround time to 2–3 days from 7–10 days, less variability in test results, and eliminating radioactive elements in the test. Financial terms were not disclosed.

Celera and Ipsen Sign Agreement for PGx Testing

Aiming to develop biomarker and pharmacogenomic tests for growth failure, Celera (Alameda, Calif.) and Paris-based pharmaceutical firm Ipsen announced that they will collaborate on the discovery and characterization of genetic markers related to the disease. The companies said that, assuming the first phase is successful, they’ll then work on diagnostic predictor tests for Ipsen’s clinical trials of drugs for growth failure. These tests could then be the basis for commercial companion diagnostic assays. “We’re pleased to enter this collaboration with Ipsen as it further reinforces Celera’s pharmacogenomic endeavors,” said Celera CFO Thomas White, PhD. “This is another example highlighting the importance of diagnostic and pharmaceutical companies working together to improve therapeutic availability through the practice of personalized disease management.” Celera gets an undisclosed payment for the initial phase of the multi-year collaboration deal, with future payments depending on the success of later phases of the project.

Siemens and BRAHMS Announce Deal for PCT Assay

Siemens Medical Solutions (Tarrytown, N.Y.) said it has signed an agreement with Hennigsdorf, Germany based BRAHMS AG for the rights to develop, produce, and distribute a procalcitonin (PCT) assay to help diagnose patients at risk for progression to severe sepsis. “Early diagnosis and appropriate therapy of sepsis is a daily challenge to intensive care units,” said Joe Bernardo, senior VP of Central Lab Testing at Siemens Medical Solutions Diagnostics. “This agreement highlights the enormous potential to help attending physicians recognize clinically relevant bacterial infections and estimate the risk of a septic complication. Our goal is to focus on new opportunities to provide the diagnostic tools necessary to diagnose and treat millions of patients.” Siemens will make the new test available on both the ADVIA Centaur and IMMULITE platforms. Brahms AG said it has several cardiac infection markers in the works that it plans to market through similar collaborations.