October 18, 2005

BioSignia Scientists Publish Synthesis Analysis Validation Study

Research Triangle Park, NC - Scientists at BioSignia have just published a validation study of the company’s Synthesis Modeling technique and its use in predicting heart disease risk for patients in the doctor’s office.

The major risk factors for heart disease have been known for a long time. They include high total cholesterol, low HDL cholesterol, high blood pressure, smoking, and diabetes. The disease is also most common in older men. These factors have been combined into a widely accepted equation of risk based on the Framingham Heart Study. But many new risk factors have been identified in recent years that are not included in that equation. These include family history, lack of exercise, obesity, the use of certain medications, and some blood values. The newer blood values include plasma fibrinogen, serum albumin, lipoprotein (a), leukocyte count, and high sensitivity C-reactive protein. BioSignia has developed a statistical technique for extending the older Framingham equation with this new information. These new equations help identify additional people at risk of heart disease.

In a recently published study in the European Journal of Cardiovascular Prevention and Rehabilitation, this way of building risk equations was tested for its reliability. First the data from the Framingham Heart Study were accessed and a simple predictive model was developed for heart disease using only age, gender, total cholesterol, and blood pressure. Then 5 other factors were added to the equation, not based on the Framingham data but based on reported results from the medical literature. This new equation was then tested against an entirely different dataset of people and their risk factors and whether or not they got heart disease in a follow-up of 20 years. Although the results varied from factor to factor, overall the new model was significantly more predictive than the simple 4-factor model. This suggests that BioSignia’s way of building and extending risk equations based on the medical literature is reasonable. It provides a means of putting the latest research findings into the doctor’s hands when it comes to identifying patients at risk of heart disease and other chronic diseases.

Synthesis Analysis, the technique demonstrated in this report, is the technique used by BioSignia to develop the predictive models in its website tool www.knowyournumber.com. The diseases covered include heart disease, type 2 diabetes, stroke, breast cancer, colon cancer, prostate cancer, lung cancer, chronic obstructive pulmonary disease (COPD), and heart failure.