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Celera Genomics (Rockville, Maryland), a business unit of Applera (Foster City, California), 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 the 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 affect 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 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.

In other dealmaking activity:

• Gentiva Health Services (Melville, New York), a provider of home health and related services, reported completing two acquisitions to expand hospice services into Tennessee and home infusion services in the Carolinas, for a combined price of about $4.5 million in cash, it said.

Gentiva acquired the assets of Lazarus House Hospice (Cookville, Tennessee), which delivers hospice services to 15 counties in Tennessee. The business will operate as part of Gentiva's Wiregrass Hospice unit, providing services in Alabama, Georgia and South Carolina. Gentiva also acquired Carolina Vital Care (Charlotte, North Carolina), a home infusion pharmacy business serving seven counties in North and South Carolina. Operating as Carolina Infusion Care, the business will complement Gentiva's home healthcare operations in the two states.

Gentiva said the purchases are not expected to have material impact on '06 operating results.

“[W]e continue to look for strategic expansion opportunities . . . so that we can grow our businesses in this important region of the country,” said Tony Strange, president and executive vice president of Gentiva.

Gentiva bills itself as the nation's largest provider of comprehensive home health and related services, serving patients through more than 500 direct service delivery units within more than 400 locations in 36 states, and through CareCentrix, which manages home healthcare services for major managed care organizations throughout the U.S.

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