Precision medicine is an approach for disease treatment and prevention that takes into account the variability in each individual. Diagnostics that can facilitate better patient stratification and identify patients for specific treatment and prevention pave the way for optimized clinical trials.
For example, over 50 percent of drugs that fail in Phase III do so because of insufficient efficacy. Estimates vary on the cost of a failed clinical trial, but figures range anywhere from $800 million to $1.4 billion.
In other words, selecting the correct patients for a clinical trial, and not enrolling patients who are unlikely to respond will improve the success rate of the trial. Better patient outcomes are a byproduct of successful clinical trials.
Cardiovascular disease (CVD) is the leading cause of death for both men and women in the United States. CVD is a general term for diseases affecting the heart and blood vessels. Adults with diabetes are nearly twice as likely to die from heart disease or stroke as people without diabetes. But did you know that women with diabetes are twice as likely to have a second heart attack and four times more likely to have heart failure than women without diabetes? Furthermore, according to the American College of Obstetricians and Gynecologists, women have unique risk factors for CVD that men do not share.
Ninety percent of women have one or more risk factors for heart disease or stroke. Studies have suggested that women’s reproductive factors are associated with the risk of cardiovascular disease. These reproductive factors provide an early window into a woman’s heart disease risk and can be used to predict which women are most likely to experience a future heart disease event before the onset of established heart disease risk factors.
If you thought heart disease was reserved for post-menopausal women only, think again. Data suggests that reproductive information may be the most useful in premenopausal women, and possibly prior to the development of traditional risk factors such as hypertension, diabetes, and dyslipidemia. Among younger women, reproductive factors often precede the onset of established CVD risk factors and could thus guide risk factor modification.
The correlations between these reproductive factors and heart disease risk in women have largely been ambiguous; until now. With new developments made by LifeStory Health, this could all change using the Company’s patent-pending technology that stratifies women using menstrual blood.
While we know a woman’s CVD risk rises after menopause, somehave found that pathologic changes, such as atherosclerosis (the build-up of fats, cholesterol, and other substances in and on the artery walls), begin during premenopausal years, especially in women with ovarian dysfunction.
Furthermore, normal ovarian function is cardioprotective (serving to protect the heart mainly from heart disease), whereas autopsies of women as young as age 34 found that even mild changes in ovarian function increase CVD risk.
In the healthcare journal Heart, Dr. Sanne Peters and co-author Professor Mark Woodward describe how they examined data from the UK Biobank to statistically link reproductive factors to heart disease. They found that women undergoing natural menopause before the age of 47 had a 33% higher risk of CVD, with an increased risk for both coronary heart disease and stroke. Miscarriage and hysterectomy were linked to a 14% and 20% higher risk of coronary heart disease respectively, while stillbirth was linked to a higher risk of stroke.
“Further research into the underlying causes of these findings is vital because this helps us to come up with interventions, either population-based or individual-targeted,” said Peters.
LifeStory Health has identified a novel biological mechanism, based on modified proteins found in menstrual blood, arising from a unique hormonal cascade that offers a window into early-stage disease and treatment.
This recurring cycle of a unique diagnostic fluid allows for the recording of an individual specific wellness profile as well as a detailed comparison between individuals.
An earlier “window” of detection into a woman’s level of CVD risk would allow for earlier prevention – and LifeStory Health’s technology could potentially provide that early window by assessing whether a woman’s risk of CVD is low, medium or high based on her own biology using menstrual blood.
LifeStory Health’s patient stratification technology, either alone or in concert with established factors, may significantly enhance our ability to stratify young women with extraordinary molecular accuracy.