Corporation of America® Holdings (LabCorp®), and ARCA Discovery, Inc. have announced an exclusive collaboration to develop a commercial genetic test to aid in prescribing bucindolol, a genetically-targeted heart failure drug in development by ARCA. Financial terms of the agreement were not disclosed.
More than 400,000 new cases of heart failure are diagnosed annually in the United States. With this agreement, LabCorp and ARCA believe they are one step closer to bringing personalized medicine to the millions of patients worldwide suffering from heart failure and other forms of debilitating heart disease.
The new test will identify common genetic variations of the alpha-2c and the beta-1 adrenergic receptors that regulate the human heart. A patient's response to bucindolol appears to be affected by these genetic variations. Certain variants are associated with a strong positive benefit in the majority of patients, while others are associated with side effects and no benefit.
ARCA plans to seek approval of the drug with the genetic test to assist physicians in determining whether bucindolol is an appropriate therapy for their heart failure patients.
The companies anticipate that patients who are candidates for bucindolol would be given the genetic test, which is currently under development, together with other diagnostic procedures that are commonly performed when treating heart failure.
"We are excited to partner with LabCorp, a pioneer in commercializing new diagnostic tests," said Richard B. Brewer, CEO and President of ARCA Discovery.
"LabCorp's ability to develop a scalable, commercial genetic test, backed by its extensive resources and national distribution, was ideal. We believe that our success with bucindolol and its companion genetic test can help physicians achieve a more personalized approach to treating heart failure," Brewer continued.
"We are pleased to partner with ARCA on this groundbreaking project and to provide them an end-to-end laboratory solution, from assay design and clinical trials testing to full commercial testing services," said Myla P. Lai-Goldman, MD, Executive Vice President, Chief Scientific Officer and Medical Director for LabCorp.
"This collaboration is an important step in advancing the efficient and widespread delivery of personalized medicine. It represents an exciting new model for the drug development industry," Goldman said.
ARCA plans to seek regulatory approval for bucindolol in 2007. LabCorp will develop the commercial genetic test for bucindolol in parallel with the drug approval process.
"One of LabCorp's key strategic initiatives continues to be scientific differentiation," said David P. King, Chief Executive Officer of LabCorp.
"This agreement exemplifies how LabCorp, in partnership with pharmaceutical firms such as ARCA, can apply its scientific expertise to provide physicians with laboratory tests that help improve individual patient outcomes, avoid adverse drug reactions and offer a strong value proposition to health care providers," he continued.