Point of Care Requirements = potential to be the Standard of Care
Accurate and more sensitive to the current 'gold standard' laboratory device
Easy, no specialized technician required
Small sample size: finger prick, no venipuncture required
The BioMed testing platform is a phenotype, quantitative test. Recent data suggesting that there is little if any link between genotype platelet function tests and cardiovascular events. There are several factors that affect platelet function in a patient, and individual platelet function changes over time.
“…no link between genotype and cardiovascular events.”
“I think a functional test, a test of phenotype, is much more immediate than genotype testing and takes
into account environmental factors as well
as specific genetic factors…
We also don’t have the luxury of waiting for genetic test results,”*
-EllinorPeerschke, PhD, professor of
pathology, director of the hematology and
coagulation laboratories, and associate director of the center for clinical laboratories.
"First, the genetic substudy from CHARISMA (on which I was a coinvestigator) raised questions about whether this loss-of-function polymorphism is associated with a worse outcome independent of the antiplatelet drug(s) a patient is on. Only about half of patients who have it are hyporesponders to clopidogrel, and in almost all examples I am aware of, phenotype trumps genotype.” -Dr Peter Berger (Geisinger Health, Danville, PA)
* Clinical Laboratory News, AACC, August 2011, Vol. 37, Number 8 www.aacc.org
The BioMed technology and test are not FDA approved at this time.