Extracting Secrets from a Tampon to Revolutionize Women’s Healthcare

We often quip that if we can send someone to the moon in 1969, how is it that we still can’t do this or can’t do that. And in many fields, we have made outstanding accomplishments: self landing rockets, autonomous cars, personalized cancer therapeutics, and CRISPR editing technologies; these and other technological advances we have made in the last century are phenomenal. But it is astonishing that 50 years after we landed on the moon, we still have very little understanding of the most basic female-specific etiologies. As a matter of fact, it’s crazy to think that there were no mandates to include women in cardiovascular clinical studies until the NIH Revitalization Act in 1993. Despite this act, the mandate only regulated federally funded trials but not those conducted by companies or even FDA regulated studies. And even after this, mixed gender trials still had a gross under-representation of women. For example, only 27% of patients enrolled in NHLBI sponsored randomized Phase 3–4 clinical trials to study cardiovascular disease between 1997–2006 were women. More specific studies during that time period e.g. Sudden Cardiac Death, only had 17% women subjects. [1] Before 1993, the problem was even more glaring, to the point of being sheerly ridiculous. For example, the famous Physicians Health Study in 1989, that enrolled physicians to take part of a study that ultimately concluded that taking low dose (81mg baby aspirin daily) reduced the risk of heart disease, had slightly over 22,000 study subjects, all of which were men.[2]

Many trials, even beyond cardiovascular health, are woefully under-enrolling female participants.[3]This occurs even in therapeutics that are directed solely to women. For example, a study investigating the effect of alcohol interactions with Addyi, a drug meant to increase female libido, enrolled 23 men and 2 women.[4] To put all this into a sobering perspective, these were not studies conducted at incredulous institutions but rather studies conducted in the Harvard and Yale systems and published in journals like the New England Journal of Medicine.

Ok, we have to ask ourselves “Why?”. The explanation you’ll hear from scientists and clinicians is that women are largely excluded from clinical trials because of hormonal fluctuations that make monitoring drug effects difficult. In most clinical studies intended to prove a certain pre-formulated hypothesis, there is always an implicit objective to minimize variability that could create surprise deviations in late phase pivotal studies. But what if the variability itself is the most valuable component to understanding female biology? As a scientific community, we have to embrace the noise of variability that we have traditionally tried to minimize or eliminate can actually be valuable signal.

But in order to do this, we must also embrace that when looking for biological phenomena driving women’s health conditions, instead of looking in nongender-specific conduits, such as systemic blood, it makes perfect sense to go to the source of the cyclical variability — menstrual fluid.

This is the foundation of the technology platform NextGen Jane is developing to help assess women’s health conditions, a company we are proud to have invested in. The technology is based on the following key premises:

· When looking for key genomic markers specific to the expression of female reproductive disorders, measure at the source.

· The most natural biopsy of the reproductive system is tissue shed during menstruation –a truly non-invasive sampling modality based on a tampon.

· In a time when there is lack of easy access to Gyn specialists in certain geographies, a trend toward high-deductible healthcare plans with high out-of-pocket minimums, and shame associated with female biology, we must empower women with actionable data, in order to facilitate proactive participation in their own healthcare.

This is seen most clearly in a condition called endometriosis — where the tissue that lines the uterus grows in other areas of the body such as the fallopian tubes, ovaries and rectum. This tissue thickens and bleeds during the menstrual cycle, like it would in the uterus, causing extreme swelling and pain. It is reported that 10% of women in the US are afflicted with endometriosis (a current prevalence of 5M-10M women). This condition is by no means limited to advanced ages. Many teenage girls are afflicted with chronic pelvic pain (CPP). In a study of patients younger than 22 years of age with CPP whose pain did not respond to an oral contraceptive (OC) or a non-steroidal anti-inflammatory drug, 70% were subsequently found at laparoscopy to have endometriosis.[5]

Sadly, there is no definitive diagnosis of endometriosis other than direct observation of diseased tissue via laparoscopic surgery. Sadder still is the fact that given current practices, many of which may be dictated by payors, it often takes women 5–10 years, having to jump through a litany of steps, before they are officially diagnosed. As a result of prolonged diagnosis and missed treatment options, it is estimated that it currently costs $17 B to treat endometriosis patients in the US.[6]

I invite you to read the journey the two founders of NextGen Jane have taken (https://www.youtube.com/watch?v=BgXgX1ISKBM&feature=youtu.be), leveraging their work developing genomic screenings for infectious diseases in West Africa, to create an innovative technology that enables a simple and elegant solution for women of all backgrounds to take control of their reproductive health.





[5]Laufer MR, Goitein L, Bush M, Cramer DW, Emans SJ. J Pediatr Adolesc Gynecol. 1997;10(4):199–202

[6]Gao X, Outley J, Botteman M, Spalding J, Simon JA, Pashos CL. Economic burden of endometriosis. Fertil Steril. 2006;86(6):1561–1572