PHILADELPHIA—CytoVas LLC and BD Biosciences, a division ofBecton, Dickinson and Co., have announced a strategic alliance for the jointdevelopment of a new blood-based diagnostic test for the individualizedprediction of a patient's risk of heart attack and stroke.
Under this alliance, CytoVas will be performing severalexperiments to optimize the test and potentially increase its predictive power.BD Biosciences will assist in planning and provide reagents and instrumentationfor the experiments. The alliance has an expected duration of at least twoyears, after which the companies will evaluate their options for pursuingregulatory and reimbursement approval for marketing the test.
"I believe the VHP will become instrumental in guidingtreatment decisions by helping us understand what is happening—in real-time—atthe 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 clinicaltreatment as well as aiding industry as a biomarker or companion diagnostic fortherapeutic innovation."
The test is currently known as the Vascular Health Profile,and is a "multicomponent clinical assay that integrates a number of cellularbiomarkers of genetic and environmental risk factors, including vascularmicroparticles and circulating endothelial progenitor cells, into acost-effective, clinically significant profile using unique computationalmethods," CytoVas notes on its website.
The alliance represents the first time the two companieshave worked together, though Warner notes that BD Biosciences has an existingrelationship with CytoVas' founders, particularly those involved with flowcytometry at the University of Pennsylvania. The use of flow cytometry in acardiovascular diagnostic is a bit of a first too, he says.
"The work that we've been doing with the founders in theirclinical labs was more, shall we say, in the conventional areas that flow isused, particularly leukemia analysis, autoimmune disease, AIDS testing and soon," he explains. "But what BD has been looking for is how to really expand theuse of flow cytometry in clinical applications."
Cardiovascular disease research, he says, was not anapplication people had thought about much for flow cytometry, which is theanalysis of cells or particles, generally in blood, bone marrow or other cellsuspensions. However, Warner explains that "it's the shedding of variousparticles from the atherosclerotic lesions and so on into the bloodstream thatthen we can analyze in flow, that may give you a lot of information about thestatus of the vasculature and its potential predisposition to disease and soon."
Through this alliance, CytoVas will be able to determine theVascular Health Profile's ability to assess the progression of cardiovasculardisease as well as the cardiovascular-related efficacy and side-effect profilesof various medicines.
"I come from a drug development background, and I see a lotof promising new therapies failing in late-stage clinical trials because of thepotential impact of those new medications on cardiovascular health," says Dr.Todd Johnson, president of CytoVas. "I realized that if we could have a betterunderstanding, if there were a way that we could better assess the impact ofexperimental medicines on a patient's risk of heart attack and stroke, then wecould ensure that those medicines that are having a positive effect are gettingto market more quickly and that we're getting more accurate results of thatproblem in the clinical testing environment."
"For the American healthcare system, the Vascular HealthProfile is a potential game-changer," Ross Tonkens, a cardiologist and head ofthe American Heart Association's Science & Technology Accelerator Fund,commented in a statement. "This test not only offers the promise of identifyingsymptom-free individuals at high risk, but could also assess the effectivenessof new therapies to prevent heart attack and stroke."
More than 82 million people in the United States alone areafflicted with atherosclerotic cardiovascular disease, which remains a leadingcause 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.