March 2007 Clinical Laboratory News: Industry Profiles

March 2007: Volume 33, Number 3

Quest Diagnostics Acquires HemoCue for $420 Million
Quest Diagnostics (Lyndhurst, N.J.) stepped into the POCT testing market in early February, announcing the acquisition of Ängelholm, Sweden-based HemoCue, a manufacturer of globally-marketed handheld testing systems for hemoglobin, glucose, and most recently, WBC. The $490 million deal gives Quest access to annual revenues of approximately $90 million and a microfluidic technology that Quest said will complement its own efforts to develop POC tests for infectious disease and cancer. “Technology is enabling diagnostic testing to move closer to the patient, and the acquisition of HemoCue and its exciting product pipeline gives us a strong presence in this emerging market,” said Quest CEO Surya Mohapatra, PhD. “Linking near-patient testing devices to our Care360 patient-centric physician portal can provide longitudinal test reporting on a patient regardless of how or where a test was performed. This will help doctors improve the way they diagnose, monitor, and treat disease.”
Olympus Working on Personalized Chemotherapy Test 
In a new deal with Saladax Biomedical (Salt Lake City, Utah), Olympus America, Inc. (Bethlehem, Pa.) will offer an assay that quantifies the concentration of the chemotherapy drug Fluorouracil (5-FU) in cancer patients. According to a press release issued by Olympus, the new assay will help oncologists determine the best dose of the drug for each patient. “There is a large body of published clinical evidence that managing 5-FU dosing by measuring blood concentration has a significant positive impact on response to therapy and reduction of toxic side-effects. However, today doctors have no clinically relevant tool by which to get this information,” said Saladax CEO Salvatore Salamone, PhD. Under the agreement, Saladax will adapt its 5-FU assay for Olympus’ AU400 clinical chemistry analyzer. Olympus advanced Saladax an undisclosed sum of money for the assay, although at press time the final terms of the agreement had not been reached.
Companies Developing Rapid POC Test for HCV
Oral fluid diagnostics maker OraSure Technologies, Inc. (Bethlehem, Pa.) and pharmaceutical manufacturer Schering-Plough (Kenilworth, N.J.) announced an agreement for the development and promotion of a rapid oral test for the detection of antibodies to HCV using OraSure’s OraQuick platform. Schering-Plough will reimburse OraSure for a portion of the costs of developing the test and will also help promote the test in the physicians’ office market in the U.S. “As a long-term innovator and leader in the hepatitis therapy area, Schering-Plough is the ideal partner to help us introduce our rapid, point-of-care oral HCV test to the U.S. physicians’ office market, once our product receives FDA approval. We believe a rapid oral fluid HCV test has significant commercial and medical value in that it will help identify more individuals who are infected, thus enabling them to receive appropriate treatment,” said OraSure CEO Douglas Michels. The tests will be co-branded and include Schering-Plough’s free HCV patient support program. The deal’s initial term expires 2 years from the date the test sells commercially.
Bio-Rad Gets RA Test, Makes Deal with Siemens

An agreement with Dundee, Scotland-based Axis-Shield will give Bio-Rad (Hercules, Calif.) access to Axis-Shield’s test for the early detection of rheumatoid arthritis (RA). The assay, which will run on Bio-Rad’s BioPlex 2200 system, tests for anti-cyclic citrullinated peptide antibodies (anti-CCP). “The ability to incorporate an anti-CCP test as part of a rheumatoid arthritis panel will add significantly to our growing menu of autoimmune tests on the BioPlex 2200 system,” said Bio-Rad VP John Goetz. “As the first and only fully automated, random-access multiplex testing platform, the BioPlex 2200 system is ideally suited as a platform for multi-marker autoimmune testing that includes rheumatoid arthritis.”

In a separate announcement, Bio-Rad became the first IVD company to strike a deal with the new Siemens Medical Solutions Diagnostics (Malvern, Pa.), and will offer its QC products and Unity QC data management system on the Siemens Diagnostics’ ADVIA Chemistry and ADVIA Centaur systems. The analyzers were formerly sold by Bayer’s IVD unit, which Siemens acquired in a deal that closed on the first of the year. “This is an ideal pairing,” said John Goetz, Bio-Rad’s VP of clinical diagnostics. “Customers will not only gain access to a greater breadth of quality control products, but they will also have online access to quality control data provided by thousands of laboratories worldwide for peer group inter-laboratory comparison.”

Dade Behring Licenses Hemostasis Assay

Under a licensing agreement with the Radboud University Nijmegen Medical Center (RUNMC, Nijmegen, The Netherlands), Dade Behring plans to commercialize a new test for coagulation disorders. Called the Nijmegen Hemostatis Assay (NHA), the RUNMC researchers say the test could be considered a “global coagulation test” because it screens for a broad range of coagulation disorders, including thrombophilia and fibrinolytic abnormalities. “Global tests reflecting the regulation of hemostatic balance in patients are promising tools to better assess the needs of patients,” said Wannder van Heerde, PhD, principle investigator at Radboud. “We are very delighted that Dade Behring is collaborating with us—together we expect to further expand the knowledge of global testing for thrombosis and hemostasis. The global NHA test not only has the potential to give answers about the clinical picture of the patient, but also may also be used to monitor therapy efficacy and pre-clinical studies.”

bioMérieux Picks Up Sepsis Assay

bioMerieux (Marcy L’Etoile, France) and Cepheid (Sunnyvale, Calif.) announced they will co-develop and market a new sepsis panel on Cephid’s GeneXpert nucleic acid analysis instrument. The deal calls for the companies to jointly develop the products, with Cepheid in charge of manufacturing and bioMérieux distributing the sepsis assays. The companies said they plan to develop both bacterial and fungal identification assays, as well as a series of genetic markers for antibiotic resistance. In addition to the agreement on the sepsis panel, bioMérieux granted Cepheid a non-exclusive license for its patents on methicillin-resistant Staphylococcus aureus (MRSA). “Together, we will create the next generation of molecular diagnostics systems, leveraging bioMérieux’s blood culture and immunology solutions and its deep biology expertise with Cepheid’s unique system and reagent development experience, all focused on ease of use in highly clinically relevant situations,” said BioMérieux CEO Stephane Bancel. “Together, we will bring nucleic acid diagnostics into routine clinical use to places and applications where it is needed most.”

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