Bloody Good News: Using Menstrual Blood to Detect Disease

How The Other Half Lives

These days, it’s commonly acknowledged in healthcare circles that women’s health has been unconscionably overlooked by our society – from disparities in research funding and clinical trials to medical gaslighting and poor medical education about women’s health conditions. We know that sex-based biological differences can manifest in different types of diseases impacting women (for example, women are disproportionately impacted by autoimmune disease), the same diseases (like heart attacks) presenting differently in women than men, and the same drugs (such as common painkillers) not working as effectively in women compared to men. Despite the clear need to build healthcare solutions for women, women were not included in U.S. clinical trials until the 1980s, and clinical trial participants are still predominantly male. 

The underrepresentation of women in positions of societal decision-making – including clinical research funding and startup investing – perpetuates this problem. The CEO of Morgan Health, JPMorgan’s strategic healthcare venture investment arm, described this in Forbes earlier this year:

In 2022, startups focused on women’s health earned 13.26% of health tech funding, according to Pitchbook. While this has nearly doubled since 2020, it does raise questions regarding what is getting attention. And a 2019 analysis from Rock Health found that women made up only 12.6% of partners at venture funds active in digital health, showing how far we need to go with respect to decision-making authority.

Without as many women in the room where it happens, new products and services that advance women’s health can have trouble getting funded. Just in the past month, a male investor told me women’s health isn’t investable because it “only” affects half the population (perhaps he somehow missed that Viagra surpassed $1B in sales in its second year on the market and is one of Pfizer’s best-selling drugs of all time). Female founders building in the women’s health space have reported to the BBC that “pitching to investors often means explaining the very basics of menstruation, like how tampons, sanitary pads, and menstrual cups are used.” Even when these startups do manage to raise funding, arbitrary advertising policies that categorize ads for certain women’s health products as “adult content” make marketing a challenge.

With these dynamics, it’s no wonder that we’re woefully behind in building for women’s health. But from my vantage point as a healthcare investor, it feels like things are moving in the right direction.

“Women bleed every month. Why is nobody using that?”

In recent years, many investors have recognized the opportunity to develop healthcare solutions for women, leading to the rise of new venture firms (e.g., RH Capital, Avestria, Springbank Collective, and many others) and incumbents making forays into the space (e.g., JPMorgan, HSBC). The availability of funding is enabling women’s health innovators to build new solutions for age-old problems, such as supportive services for pregnancy, diagnostics for endometriosis – a disease that impacts 11% of women and can today only be diagnosed through an invasive process involving surgery – and fertility care, an area that has seen explosive growth given the high demand and lucrative nature of this typically cash pay service.

One fascinating area of recent scientific focus is the use of menstrual blood to monitor and diagnose disease. In a society that stigmatizes menstruation, menstrual blood has traditionally been considered a waste product. But it is now starting to gain recognition as a source of data that could replace visits to the local lab for a blood draw and even provide richer information on health. This is because the fluid shed during menstruation (aka menstrual effluent) contains not only blood, but also endometrial tissue with viable cells, immune cells, nucleic acids, proteins, and microorganisms from the vaginal microbiome. A 2019 study published by Stanford researchers found that menstrual blood is as effective as systemic blood for the diagnosis of several key diseases. 

What this means in practice is that menstrual blood can be used to non-invasively monitor chronic conditions that have previously required a blood draw, like diabetes and thyroid disease; to diagnose diseases that today require invasive or uncomfortable procedures such as endometriosis and cervical cancer; and to develop new diagnostics for diseases that we don’t know much about, such as those affecting women’s reproductive organs. According to Sara Naseri, coauthor of the aforementioned study and co-founder and CEO of Qvin (pronounced like “quinn”), a company pioneering the use of menstrual blood in diagnosis of disease: 

“[Blood] is the bodily fluid that is used for diagnostics and health monitoring most often. I don't think a doctor would want to poke you with a needle in the arm unless there’s a really good reason for it. Then one day, it just sort of hit me that, wait a minute, women bleed every month. Why is nobody using that?”

A New Period of Innovation

Menstrual effluent is collected through multiple modalities, including menstrual pads, cups, tampons, and period underwear. I had the chance to speak with several amazing companies developing products in this space.

1. Qvin

Qvin has created the Q-Pad, a pad that can be used just like any other menstrual pad. Once the sample is collected, a small removable collection strip embedded in the Q-Pad can be mailed back to the company for analysis at its certified laboratory. The lab analyzes menstrual blood for several biomarkers that would typically require a blood draw at the lab, like HbA1c (a measure of average blood sugar), TSH (a measure of thyroid health), Hemoglobin (a measure of anemia), and more. They plan to expand in the future to testing for COVID antibodies and HR-HPV (a leading cause of cervical cancer). 

When I tested the Q-Pad, I also did a blood draw with a phlebotomist the same week to compare the results of my HbA1c test. The results came back exactly the same, but the Q-Pad was a much more convenient experience. (Disclaimer: The company sent me a free test kit to try; their website states that the Q-Pad will be commercially available for early access in 2024).

2. NextGen Jane

NextGen Jane uses tampons to perform deep multi-omic analysis of menstrual blood. The company plans to use the data to help consumers understand whether their menstrual experience is “normal” and to develop a more granular understanding of disease for research, diagnosis, and development of new therapies. NextGen Jane is currently focused on different areas than Qvin, starting with endometriosis, and is running several ongoing clinical studies.

3. Emm

Emm is developing a smart menstrual cup to help women better understand their menstrual health. Emm plans for its reusable cup to be as easy to insert as a tampon, comfortable, leak-proof, easy to clean, and eco-friendly. The company’s website notes that the cup’s built-in sensors will track key metrics around menstruation like volume, flow rate, cycle length, and regularity. Like Qvin and NextGen Jane, the company could use the data it collects to inform the development of diagnostics and therapeutics for women’s health.

Back to the Future (of Blood Testing)

While NextGen Jane and Emm aren’t yet available on the market, what is conceptually exciting about all three of these products is that they are turning periods from a stigmatized and  uncomfortable occurrence into a powerful opportunity to understand and improve one’s health. They analyze an underutilized data source to drive new discoveries in women’s health – and they are also incredibly convenient and easy to use. No more schlepping to the lab and sitting in a wait rooming full of potentially sick people in anticipation of a needlestick. Given that a diagnostic pad, tampon, or cup can replace the use of other menstrual care products, they fit neatly into the consumer’s existing routine. It’s difficult to imagine that most women would go into a lab for blood testing or even do an at-home capillary blood test when it becomes possible to conduct the same tests non-invasively.

Moreover, these products may be able to reduce the cost of diagnostic testing. Two significant cost drivers in the status quo of blood analysis are the expertise required for sample collection and the necessity of cold-chain shipping to keep samples within a certain temperature range. First, sample collection typically requires a phlebotomist or, in the case of cervical cancer testing, a physician using precious in-clinic time to conduct a vaginal swab or pap smear. Self-collection eliminates these costs. Second, on the laboratory logistics side, Qvin’s leadership team shared with me that their samples remain stable for at least 2 weeks, so that costlier temperature-controlled shipping isn’t necessary and there is sufficient time for samples to be shipped to a central lab (rather than to local lab sites), where centralized lab operations drive further efficiency. Driving down the cost of testing could improve accessibility to life-saving healthcare around the world.

Like all business models, these also face certain challenges. In my view, once these companies are ready to bring these groundbreaking products to market, they will likely have to overcome three major barriers:

1. Consumer adoption – For nearly all new consumer brands, generating customer awareness and trust takes time and a significant investment in marketing. These new products are entering a well-established menstrual products market with a few big, well-funded incumbents (e.g., Always, Tampax). The aforementioned advertising bans on women’s health products – including outmoded restrictions on how such products can be depicted – compound the marketing challenge. But given that they offer an expanded value proposition vs. existing products, I expect that as consumer awareness grows, these products will be popularized.

2. Healthcare provider adoption – The tougher adoption hurdle will likely be with healthcare providers. When a menstrual blood-based product reports a lab result or diagnosis, clinicians may still be wary of trusting a methodology they aren’t familiar with. This has already been a barrier to adoption for at-home blood tests where consumers use alternative sampling techniques, like a finger prick or a device like Tasso. Building clinician trust in diagnostics using menstrual blood will require generating evidence that demonstrates the accuracy of these tests and, ideally, getting them included in standard of care guidelines.¹
   
   This is a common challenge across the diagnostic testing space, and evidence generation and inclusion in clinical guidelines are commonly discussed as business drivers in public company earnings calls. For instance, GeneDx, which sells genetic sequencing tests for rare diseases, reported in its most recent quarterly earnings that clinicians prefer to order tests that use smaller (and less profitable) gene panels such as chromosomal microarray instead of more comprehensive (and more profitable) genetic tests such as whole exome sequencing because the former is still recommended by the standard of care guidelines. This has been a driver of the company’s financial struggles. It takes time for the bodies that develop these guidelines – such as the American Diabetes Association, the National Comprehensive Cancer Network, the American College of Obstetricians and Gynecologists (ACOG), etc. – to catch up with and thoroughly evaluate newer technologies. When these organizations adopt a new care guideline, including new diagnostic tests, clinicians can have confidence that the guideline has been carefully vetted through an evidence-based approach, leading to greater adoption.

   
   Companies in the menstrual blood diagnostic space are approaching this thoughtfully. Qvin’s leadership published a 2022 paper with Stanford in the prestigious Green Journal (the official publication of ACOG) that showed the Q-Pad was effective for cervical cancer screening when compared to the invasive standard of care pap smear, and was preferred by 94% of patients. NextGen Jane is running several clinical studies to generate robust evidence for its diagnostics. Daye, a period care company whose diagnostic tampon detects diseases using vaginal fluid (instead of menstrual blood), ran clinical trials and received FDA approval in 2023.²

3. Payment – While these new diagnostic products can to some extent replace existing consumer spend on standard menstrual products, the diagnostic testing component (such as laboratory costs to process tests) comes with costs that consumers aren’t typically accustomed to paying for themselves. Getting a blood draw for an A1c test or a pap smear for cervical cancer screening is typically covered by insurance, so consumers may expect new testing options using menstrual blood to also be covered by insurance. Mitigating this, however, is the fact that self-collection diagnostic tests are often more cost-efficient than traditional sampling methods for the reasons mentioned above; the Qvin leadership team expects that their significant cost advantages will make the Q-Pad affordable and accessible globally.
   
   Tests that seek insurance coverage will contend with a process that is notoriously difficult (also a commonly aired woe on earnings calls). Like providers, payers also want to see proof that the tests are accurate and comparable to existing testing options before covering them. Ultimately, these products could be a boon to payers as they could increase patients’ adherence to testing – it’s a lot easier to complete your A1c test if you don’t have to go to the lab or get a needlestick to do it. Better adherence can drive earlier diagnosis and intervention, leading to lower total costs of care for patients.

This new period of innovation (pun intended!) in women’s health is incredibly promising. Designing products specific to women’s needs is an immense financial and societal opportunity – for innovators, investors, and even employers, as companies like JPMorgan are realizing. I can’t wait to see what’s next.

A huge thank-you to Sara Naseri and Søren Therkelsen at Qvin, Ridhi Tariyal at NextGen Jane, Jenny Button at Emm, and Valentina Milanova at Daye for teaching me about this space and for your groundbreaking work in it. 

1. You might be wondering if these types of products also need FDA approval. In general, products that don’t claim to diagnose disease don’t require FDA approval, and many products that do claim to diagnose disease still don’t require FDA approval today as they can go to market as “laboratory developed tests” (LDTs). Because the LDT pathway allows companies to go to market with greater speed and capital efficiency than pursuing FDA approval, LDTs are very commonly used, such as in the prenatal genetic tests that came under scrutiny by the NYT in 2022. Some research and policy organizations have advocated for greater oversight of LDTs. The FDA has considered regulating LDTs for decades and proposed a new rule in October 2023 that, if implemented, would do so.

2. While the focus of this post is novel uses of menstrual effluent, there are also companies innovating with vaginal fluid, a data source that is available even when consumers aren’t menstruating. Standard tests such as those for STIs and yeast infections are already conducted using vaginal fluid. In contrast to the uncomfortable experience of getting a vaginal swab at the doctor’s office, Daye’s FDA-approved tampon is a non-invasive modality to collect a vaginal fluid sample. This is used by Daye to measure the vaginal microbiome, which is known to impact many aspects of reproductive health, and to diagnose several types of infections. Daye is also developing tests that would use its tampons to diagnose STIs and HR-HPV.