Female entrepreneur wants to develop a menstrual blood test to help women and also combat the bias against women in medical research.
Mention menstrual blood in any gathering and watch the topic drive most of the men from the room.
A women’s health advocate and entrepreneur wants to change all that and add a potentially powerful new weapon to the fight against disease.
To accomplish her goal, Anna Villarreal created LifeStory Health, a Boston-based company that’s trying to develop the first noninvasive menstrual blood diagnostic test.
“This is kind of my mission,” Villarreal told Healthline.
An interviewer at Health Professional Radio introduced Villarreal this way: “By sampling menstrual blood as a means of collecting biologically relevant proteins to test for internal health in a noninvasive manner, she is developing a method and business model that promises to influence women’s healthcare.”
At the moment, medical testing is male-dominated.
The science basically assumes that women’s bodies are the same as men’s, except a bit smaller.
For example, two-thirds of the 5 million people currently diagnosed with Alzheimer’s disease are women. Moreover, an American woman’s overall lifetime risk of developing Alzheimer’s is almost twice that of a man.
According to Villarreal, “The prevailing thinking in the field is that this is simply because women live longer.”
But Alzheimer’s researchers have begun looking past that assumption.
Early discoveries indicate that the impact of hormonal changes at menopause, and sex differences in gene expression, may be involved as well.
According to the Alzheimer’s Association, brain studies in men are more frequent than those in women by a ratio of better than 5-to-2.
According to a
Heart disease is also affected by gender.
Men outnumber women by two-thirds in cardiovascular disease clinical trials, Villarreal wrote in CEOWORLD magazine.
Yet, heart disease is the
Menstrual blood is the most logical biologic agent specific to women, and Villarreal isn’t the only person to think so.
Jared R. Auclair, PhD, is the director of executive training and biotechnology programs at Northeastern University. He has expertise in molecular biology, protein biochemistry, analytical chemistry, protein crystallography, and biological mass spectrometry.
“Proteomics [the large-scale study of proteins] is a well-defined technology in the development of biomarkers,” he told Healthline. “However menstrual blood, as a resource for biomarkers, is indeed an unexplored resource — one that is rich in biological information.”
Just how the material would be obtained is still being developed, Villarreal said.
At present, she thinks it might operate in a fashion similar to Cologuard, in which a doctor orders a test that comes in a small envelope. Inside are simple instructions on how to collect a stool sample, which is then mailed to a lab. The lab reports the findings to the doctor.
As an added benefit, Villarreal said the process takes what’s normally considered medical waste and turns it into a medical resource.
“As it is a resource specific to women, it will likely provide unique opportunities to advance women’s health issues and diagnostics,” Auclair said. “Diagnostics, historically, have been developed without sex in mind, when we know that men and women are different biologically, and when it comes to certain disease prevalence.”
But not everyone has gotten with the program.
In a 2014 report, researchers at the Brigham and Women’s Hospital in Boston detailed the exclusion of women from health research and its effects on women’s health.
Research routinely fails to consider the crucial impact of sex and gender, researchers said.
This happens in the earliest stages of research, when females are excluded from animal and human studies, or the sex of the animal isn’t stated in the published results.
Once clinical trials begin, researchers frequently don’t enroll adequate numbers of women. Or, when they do, they fail to analyze or report data separately by sex, researchers said.
The result is an inability to identify important differences.
The chemical industry has also questioned the need for additional tests, as have some prominent researchers.
“There is really no tendency for a chemical to impact one gender differently than another unless the chemical behaves like a sex hormone or targets a specific organ or tissue that is different in males and females (for example, reproductive organs),” said Michael DiBartolomeis, PhD, chief of the exposure assessment section of the California public health department’s environmental health investigations branch.
Writing in CEOWORLD Magazine, Villarreal said, “I believe that the omission of women as research subjects is putting women’s health at risk and that we need to fuel a conversation that will improve our healthcare and livelihood.”
“It seems incredible that after hundreds of years of research, no one has isolated this approach. But this provides an opportunity to close the sex gap in medical research quickly, effectively, and economically,” she added.