A Diagnostics & Imaging Week

Celera Genomics (Foster City, California), a business unit of Applera (Rockville, Maryland), reported that it has granted Specialty Laboratories (Valencia, California) a non-exclusive license to Celera's risk markers for cirrhosis. The agreement allows Specialty to select from among Celera's genetic findings to develop and commercialize a genetic test that predicts risk of progression to liver cirrhosis in individuals infected with hepatitis C virus (HCV).

Specialty will pay Celera an undisclosed up-front license fee upon successful validation of Specialty's test, and royalties on net sales for Specialty's commercial use of the test in the U.S. Further financial details were not disclosed.

Specialty said it intends to develop a constellation of single-nucleotide polymorphisms (SNPs), based on Celera's findings, that predict risk of cirrhosis in patients with chronic HCV that are believed to be more useful than present clinical risk factors in managing the disease.

The use of a combination of SNPs as a prognostic tool, Specialty said in a statement, "suggests information may be applicable to a larger number of HCV-infected individuals, may prove more robust across risk groups tested and may have more compelling use for patient management than current methodologies."

James Peter, MD, PhD, founder and chairman emeritus of Specialty, said, "We believe the molecular diagnostics market is growing, particularly for innovative testing services such as those derived from Celera's genetic markers. Currently, there is an unmet medical need for a predictive method to determine which patients with chronic HCV are likely to develop fibrosis and progression to cirrhosis."

Kathy Ordonez, president of Celera, said, "Specialty shares in our belief that our cirrhosis risk markers could lead to testing that could have a beneficial effect on hundreds of thousands of patients with chronic HCV infection, and we are committed to maximizing the success of Specialty in commercializing results from our genetics discovery."

SNPs associated with cirrhosis were identified and confirmed through multiple research studies conducted over three years involving about 1,500 individuals infected with chronic hepatitis C. Samples were tested for the presence of around 25,000 SNPs as part of a Celera functional genome scan. SNPs identified as associated with risk for cirrhosis through initial research disease association studies, that survived replication by studying these SNPs with additional research samples, were used to develop a training algorithm to select the optimal constellation of SNPs. These SNPs were finally studied in another set of research samples to confirm their performance in predicting risk for cirrhosis.

Celera said it is currently pursuing this program independently, outside of its alliance with Abbott (Abbott Park, Illinois).

Projections based on the current prevalence of infection and anticipated rates of progression raise concerns over the potential impact of HCV during the next two decades. A computer cohort simulation of the U.S. population for 2010-2019 suggests that the morbidity and mortality associated with chronic hepatitis C will increase dramatically to 165,900 deaths from chronic liver disease, 27,200 deaths from hepatocellular carcinoma (HCC), and $10.7 billion in direct expenditures related to HCV treatment.

Specialty, a subsidiary of AmeriPath (Palm Beach Gardens, Florida), partners with pathologists and hospitals to improve patient care and reduce episodes-of-care costs.

Sirona Dental Systems (Long Island City, New York), a manufacturer of high-tech dental equipment, reported the closing of its merger with Schick Technologies (Long Island, New York), a developer of digital radiographic imaging systems and devices for the dental industry.

The stock of the combined company – now named Sirona Dental Systems and with primary headquarters in Bensheim, Germany – has begun trading on the Nasdaq under new symbol SIRO.

The deal, a reverse merger transaction valued at $1.46 billion first unveiled last September, was billed by the two firms as creating "a global player in dental technology, with strong product lines in all of the major dental segments."

The merged company describes itself as having "a strong global presence and breadth of products based on complementary technologies, geographic coverage and channel strengths." Schick claims a leading position in digital intra-oral imaging systems in North America, while Sirona is a leading supplier of CAD/CAM restoration equipment, panoramic and intra-oral imaging systems, treatment centers and instruments worldwide.

Jost Fischer, president, CEO and chairman of the combined firm, said, "We believe that, as a result of our combined strengths, Sirona will be best positioned in the industry to leverage opportunities into further and sustained growth. The merger with Schick supports our strategy of maintaining our leadership position in high-tech dental equipment."

The company will have more than 1,900 employees on five continents. Sirona's revenues for FY05 were $464 million. Schick's revenues for its last fiscal year ended March 31 were $70 million. Sirona Dental Systems said it expects to achieve annual synergies of $5 million to $7 million within 12 to 24 months. The business combination is expected to be accretive to Schick's 2006 earnings per share.

In other dealmaking activity:

Siemens Medical Solutions USA (Malvern, Pennsyl-vania) and Diagnostic Products (DPC; Los Angeles) re-ported expiration of the Hart-Scott-Rodino waiting period for their merger agreement.

The deal, valued at about $1.86 billion, was first announced in April, with Siemens bannering it as a move to enter the "personalized" medicine space via DPC's technologies: automated body fluid analyzers and tests.

As reported, the boards of the two companies have approved the agreement. DPC shareholders will vote on the deal, which is subject to other customary closing conditions, at a special meeting July 27.

DPC, founded in 1971, develops in vitro diagnostics, including the Immulite series of immunoassays, more than 75 immunoassays and an expanding menu of specific allergens and allergy panels. DPC also designs and manufactures automated laboratory instrumentation and automation solutions and a combined chemistry and immunoassay menu.

Pelican Life Sciences (Charlotte, North Carolina) reported completing the acquisition of Continental Lab-oratory Products (CLP; San Diego), PGC Scientifics (PGC; Frederick, Maryland) and Kemp Biotechnologies (also Frederick).

Financial terms were not disclosed.

Founded in 1989, CLP manufactures disposable fluid-handling plastics, reagents and instrumentation used in molecular biology research. It has ISO-certified operations in Baja, Mexico, with distribution facilities in San Diego; Charlottesville, Virginia; and Northampton, UK.

PGC manufactures molecular biology and scientific product "niche" consumables for academic, government and biotech research. Included with the acquisition of PGC is its manufacturing subsidiary, Labcor Products (Frederick).

Founded in 1992, Kemp supports laboratory research by providing expertise in cell culture, protein expression and protein purification on a contract basis. Through its subsidiary, GeneChoice (Frederick), Kemp provides molecular biology reagents and kits.

"These three new acquisitions combined with our acquisition of PML Microbiologicals [Wilsonville, Oregon] in December of 2005, form a solid foundation for Pelican Life Sciences," said CEO Bill Baugh. "Pelican Life Sciences now holds a molecular biology platform and a microbiology platform and we plan to make significant investments in each of these companies to accelerate product development and enhance growth opportunities."

Pelican is focused on microbiology, molecular biology and non-commodity, specialty consumables and is backed by $100 million in equity capital commitments.

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