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PHILADELPHIA—CytoVas LLC and BD Biosciences, a division of Becton, Dickinson and Co., have announced a strategic alliance for the joint development of a new blood-based diagnostic test for the individualized prediction of a patient's risk of heart attack and stroke.
Under this alliance, CytoVas will be performing several experiments to optimize the test and potentially increase its predictive power. BD Biosciences will assist in planning and provide reagents and instrumentation for the experiments. The alliance has an expected duration of at least two years, after which the companies will evaluate their options for pursuing regulatory and reimbursement approval for marketing the test.
"I believe the VHP will become instrumental in guiding treatment decisions by helping us understand what is happening—in real-time—at the actual site of a patient's atherosclerotic plaque, the endothelium," Dr. Noel Warner, worldwide vice president of Scientific Affairs at BD Biosciences, said in a press release. "This could be instrumental in guiding clinical treatment as well as aiding industry as a biomarker or companion diagnostic for therapeutic innovation."
The test is currently known as the Vascular Health Profile, and is a "multicomponent clinical assay that integrates a number of cellular biomarkers of genetic and environmental risk factors, including vascular microparticles and circulating endothelial progenitor cells, into a cost-effective, clinically significant profile using unique computational methods," CytoVas notes on its website.
The alliance represents the first time the two companies have worked together, though Warner notes that BD Biosciences has an existing relationship with CytoVas' founders, particularly those involved with flow cytometry at the University of Pennsylvania. The use of flow cytometry in a cardiovascular diagnostic is a bit of a first too, he says.
"The work that we've been doing with the founders in their clinical labs was more, shall we say, in the conventional areas that flow is used, particularly leukemia analysis, autoimmune disease, AIDS testing and so on," he explains. "But what BD has been looking for is how to really expand the use of flow cytometry in clinical applications."
Cardiovascular disease research, he says, was not an application people had thought about much for flow cytometry, which is the analysis of cells or particles, generally in blood, bone marrow or other cell suspensions. However, Warner explains that "it 's the shedding of various particles from the atherosclerotic lesions and so on into the bloodstream that then we can analyze in flow, that may give you a lot of information about the status of the vasculature and its potential predisposition to disease and so on."
Through this alliance, CytoVas will be able to determine the Vascular Health Profile's ability to assess the progression of cardiovascular disease as well as the cardiovascular-related efficacy and side-effect profiles of various medicines.
"I come from a drug development background, and I see a lot of promising new therapies failing in late-stage clinical trials because of the potential impact of those new medications on cardiovascular health," says Dr. Todd Johnson, president of CytoVas. "I realized that if we could have a better understanding, if there were a way that we could better assess the impact of experimental medicines on a patient's risk of heart attack and stroke, then we could ensure that those medicines that are having a positive effect are getting to market more quickly and that we're getting more accurate results of that problem in the clinical testing environment."
"For the American healthcare system, the Vascular Health Profile is a potential game-changer," Ross Tonkens, a cardiologist and head of the American Heart Association's Science & Technology Accelerator Fund, commented in a statement. "This test not only offers the promise of identifying symptom-free individuals at high risk, but could also assess the effectiveness of new therapies to prevent heart attack and stroke."
More than 82 million people in the United States alone are afflicted with atherosclerotic cardiovascular disease, which remains a leading cause of death worldwide.
"We think that what we've found is a way to very, very rapidly accelerate new diagnostic discovery, and we're very excited about that," says Johnson.