October 2007 Clinical Laboratory News: Industry Profiles

October 2007: Volume 33, Number 10

Celera to Acquire Berkeley HeartLab

Rockville, Md.-based Celera Group announced a $195 million cash deal to purchase privately-held Berkeley HeartLab (Burlingame, Calif.), which is known for its specialty personalized CVD management and esoteric testing business that has seen double-digit growth so far this year. “This acquisition provides Celera with a commercial infrastructure to drive adoption of many of its emerging new molecular diagnostics tests that predict risk and individualize treatment in cardiovascular disease,” said company President Kathy Ordonez. “Celera’s genetic markers that are intended to identify people at risk for early heart attacks, stroke, and blood clots and optimize therapy with cholesterol-lowering drugs, aspirin, anti-coagulants, and other cardiovascular drugs should augment Berkeley HeartLab’s current disease management offerings to patients.” Combining Celera’s technology with Berkeley HeartLab’s operations will improve overall efficiencies and economies of scale, said Frank Ruderman, the company’s CEO. After the transaction is complete, which the companies said should be sometime in the second quarter of 2008, Berkeley HeartLab will operate as a business unit of Celera. 

Nanogen Inks Deal for Schizophrenia Markers, Raises $20 Million

Through an agreement with the Cooperative Research Centre for Diagnostics and Queensland University of Technology, both in Brisbane, Australia, Nanogen said it plans to use markers for schizophrenia to create diagnostic tests for that disease and for related conditions. Nanogen said that the markers it acquired are in genes that have been linked to schizophrenia in multiple clinical studies, and that some of the markers might also be useful for predicting adverse drug reactions and to guide therapeutic decision making. “Due to its complexity, schizophrenia, like many mental disorders, is believed to be caused by mutations in multiple genes,” said Nanogen COO David Ludvigson. “Development of effective diagnostics and treatments is likely to require multiplexed analytic methods capable of examining multiple genes simultaneously.” Nanogen recently submitted its NanoChip multiplexing instrument for FDA clearance.

The company announced separately that it has signed for $20 million of financing from institutional investors. Founded in 1991, the company has yet to make a profit, yet in recently reported financial results, has reported revenues 60% higher than in the same quarter of 2006, and almost 10% higher than the first quarter of this year.  

PolyHeme Headed to FDA Despite Disappointing Clinical Trial

Even though a Phase III trial missed its primary endpoint, Northfield Labs (Evanston, Ill.) still plans on moving forward with the submission of a BLA (biologic license application) for its oxygen-carrying blood substitute PolyHeme to the FDA early next year, according to a recent letter to the company’s shareholders. Northfield is currently preparing the application and will request priority review. In the trial, no statistically significant difference was found between those who received PolyHeme and the control group for Day 1 mortality, 30-mortality, or serious adverse events (SAEs). “We believe that when our observed data are extrapolated to those patients who need an oxygen carrier and have delayed access to blood, PolyHeme can play an important role in saving lives,” the letter says. “The safety analysis revealed some confounding findings, but we believe the safety profile observed is within an acceptable risk-benefit profile for bleeding patients at risk of dying when blood is not available.” Northfield also announced plans to publish in a scientific journal results of an independent, blinded review of the cardiac profiles of all of the 720 randomized patients who participated in the trial, with the aim of explaining some of the product’s shortcomings in the Phase III trial.

Clinical Data Acquires PGx Firm, Begins New Research

Clinical Data (Newton, Mass.) announced the acquisition of privately held Epidauros Biotechnology AG (Bernried, Germany) for approximately $11.84 million. Epidauros brings an intellectual property portfolio including biomarkers in genes related to prominent drug transporters and important cytochrome P450 drug metabolizing genes. The deal will boost Clinical Data’s ability to bring pharmacogenetic tests to market, and Epidauros’s portfolio boasts markers that could help understand drug response in individuals, said Clinical Data CEO Drew Fromkin.

In a separate agreement, Clinical Data and The George Washington University (Washington, D.C.) announced a new collaboration to examine genomic testing of patients receiving warfarin treatment. The program will enroll 80 patients who have been prescribed warfarin as a treatment measure following orthopedic surgery, of which a randomly-assigned half will have their warfarin dose determined with the help of Clinical Data’s PGxPredict:WARFARIN assay. “Warfarin is a drug with both valuable benefits and serious risks, so it is an ideal candidate for assessing whether pharmacogenetic testing can improve patient outcomes and reduce treatment costs,” said Clinical Data Chief Medical Officer Carol Reed. If results of the program are positive, the university said it will incorporate pharmacogenetic testing into routine practice.



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