Not everyone at risk has conventional risk factors (e.g. high blood pressure, cholesterol, smoke, etc.). For millions of people, the first sign is an acute event such as a heart attack or stroke.
In addition to informing a patient of a general diagnosis and prospective risk, our tests can also inform personalized interventions because the biosignatures map to a combination of modifiable risk factors (e.g. cholesterol). Because DNA methylation is dynamic, our tests can monitor response to interventions and treatments.
We estimate our tests will cost $500 or less, compared to hundreds or thousands of dollars for current approaches.
Our tests require only 100 µl of whole blood, do not require fasting, and do not involve complicated lab or computational techniques, unlike current approaches that require large amounts of blood. We prepare DNA from the extracted blood, apply the ddPCR™ panel, and upload the output to a server to diagnose disease, assess risk, and recommend personalize interventions.
Heart disease and stroke arise from the complex interplay of a number of lifestyle factors (e.g. dietary fat intake, smoking, sedentary activity levels) with underlying genetic variation. Our technology is more sensitive than the current standard (>30% for CHD1) because it simultaneously captures both genetic and environmental (lifestyle) complexities, the latter of which can be measured epigentically.
In less than 12 hours, our tests dramatically reduce time for clinician-initiated, personalized interventions from days to hours.
While our tests runs on the BioRad system, we can adapt them to other systems.
Because our tests can run DNA from as little as a drop of blood, they can be easily scaled using pin-prick technology. Much of the sample processing can be automated, thereby improving throughput. Our tests can be performed across many testing facilities to accommodate increasing demand.
Because biosignatures map to a combination of modifiable risk factors, in the future they can be coupled to technologies and therapies for risk modification.