‘a Medical Miracle’: Is Period Blood ‘the Most Overlooked Opportunity’ In Women’s Health?

Somewhere successful nan US a female connected her play pulled retired her dripping, saturated tampon. But alternatively of wrapping it successful toilet insubstantial and tossing it into a bin, she put nan tampon successful a typical integrative sample container, screwed nan lid connected tight and mailed it to an reside successful Oakland, California.

The reside was that of NextGen Jane (NGJ), a Bay Area-based startup founded successful 2014. And now Julia Carr, NGJ’s objective investigation coordinator, stands successful nan company’s laboratory nether a fume hood happily decanting a substance of nan woman’s humor and a preservation solution into a trial tube. She will spell connected to pipette retired mini amounts to frost and shop for later analysis. NGJ has obtained astir 2,500 menstrual humor samples this measurement – from women volunteering to nonstop successful their utilized tampons – for its research. That Carr is dealing pinch their play humor does not gross her retired successful nan slightest. “This is simply a beautiful task for women’s science, and we are exploring a caller sample type,” she says.

NGJ is 1 of a fistful of small, mostly women-led “femtech” startups that, alongside a fewer world investigation teams, are successful a title to create humor tests utilizing menstrual effluent collected noninvasively astatine home. Usually, we usage urine, saliva and, of course, humor drawn from our veins to trial for a scope of aesculapian conditions. The FDA-approved Cologuard trial allows group to cod their ain feces and nonstop them disconnected for screening for colon and rectal cancer. These groups ask: why not besides a fluid that half nan world’s organization produces monthly for a agelong long of their lives?

The large accent is connected diagnosing gynaecological and reproductive wellness conditions for group who nonstop successful their play humor for analysis. But that humor could besides beryllium utilized to thief way hormones, surface for cancers, show diseases specified arsenic glucosuria and boost stem compartment research. If Theranos became shorthand for Silicon Valley junk science, its proponents put menstrual-blood testing astatine nan different extremity of nan spectrum: an underexplored sample root whose objective imaginable is only now being examined pinch technological care.

NextGen Jane’s postulation kit. Photograph: Courtesy of NextGen Jane

“It is an evident biologic specimen that has been wholly neglected,” says Christine Metz, who co-leads nan Research Outsmarts Endometriosis (Rose) task retired of nan Feinstein Institutes for Medical Research astatine Northwell Health. “It is considered discarded but successful truth it’s a existent treasure.”

No 1 had fixed overmuch thought to analyzing menstrual effluent – which contains a operation of insubstantial from nan lining of nan uterus (the endometrium) arsenic good arsenic circulating humor and vaginal fluid – for nan intent of aesculapian testing until nan mid-2010s, erstwhile nan Rose task and companies specified arsenic NGJ arrived connected nan scene. (“You matter PERIOD,” sounds a tag successful 1 of nan stalls of NGJ’s arty, graffiti-decorated bathroom.) What little activity that had been done to trial play humor prior was mostly concerned pinch distinguishing menstrual from circulating blood, for constabulary forensic purposes.

That it was overlooked for truthful agelong is not precisely astonishing to those successful nan field. Women – their bodies, their wellness concerns – person been understudied owed to a operation of humanities removal from objective research, persistent gender bias and societal stigma astir menstruation and reproductive health. Much to do pinch women’s wellness investigation is woefully underfunded.

An “ick” facet has slowed investigation pinch menstrual humor specifically, according to Renate van der Molen, an immunologist astatine Radboud University aesculapian halfway successful nan Netherlands who uses nan fluid to study various gynecological conditions. “It is thought of arsenic dirty, a spot stinky and useless … People hesitate to springiness a sample,” she says.

Yet tapping menstrual humor makes sense, she says. Not only is it noninvasive and easy to get but, astir importantly, it is unsocial successful that it contains cells and molecules that bespeak nan authorities of a uterus. It tin present messages to doctors that different bodily fluids whitethorn not. It is conscionable “so different” to humor drawn from a vein, says van der Molen.

All told, nan startups and investigation groups spot immense potential, moreover if it is early days. And 1 of nan beatified grails nan section is hotly pursuing is endometriosis.

Diagnosing endometriosis

Having an easy trial for diagnosing endometriosis would beryllium a breakthrough, says Abigail Trotter, a 23-year-old surviving pinch endometriosis from Pennsylvania. That’s why she sent her play humor to NGJ.

Endometriosis – successful which insubstantial akin to nan uterus’s endometrial lining grows extracurricular nan uterus successful spots known arsenic lesions, causing terrible pelvic symptom and dense bleeding, and making it harder to get pregnant – is simply a debilitating disease. It is estimated to afflict much than 10% of women of reproductive age. Not only is location nary cure and constricted curen options, but confirming a test tin beryllium a nightmare: nan only measurement to do it is via laparoscopic surgery, typically performed nether wide anesthesia. Because endometriosis presents otherwise successful different group and its symptoms lucifer those of different conditions, it tin return years to moreover get to nan surgical diagnostic stage.

Trotter was surgically diagnosed pinch endometriosis precocious past year, aft astir a decade of pelvic symptom and play problems. “All nan years you spell without it being diagnosed it is spreading, wreaking havoc connected your soul parts,” she says. The room itself resulted successful an under-the-skin infection that laid her truthful debased she missed six weeks of activity astatine nan veterinary session wherever she is employed arsenic a technician. (She precocious underwent further room to region her lesions robotically and is recovering well.) “A surgical process conscionable to person it diagnosed … [That] really does request change,” she says.

Trotter came crossed NGJ’s activity while recuperating from her diagnostic room and got successful touch to person a postulation kit. She wanted to thief different women debar what she went through.

Developing a noninvasive, at-home trial for endometriosis became NGJ’s main attraction successful 2021, though nan institution had been asking menstruators to message successful their utilized tampons for overmuch longer.

After receiving capable samples, nan institution started hunting for molecular signals of gynaecological conditions by analyzing DNA, RNA and proteins. Particularly beardown differences successful messenger RNA, nan molecule that tells cells which proteins to make and when, betwixt women pinch and without endometriosis stood out.

Ridhi Tariyal. Photograph: Courtesy of NextGen Jane

“We leaned in,” says co-founder and CEO Ridhi Tariyal, noting that nan institution has fine-tuned its postulation kit and is now confirming nan attack works. (She remained tight-lipped astir which nonstop biomarkers NGJ is focused on.) Tariyal adds that NGJ’s trove of stored samples provides it pinch a “jumping-off point” to research different molecular signals for different gynaecological conditions successful nan future.

Other players specified arsenic nan Rose task are trying to create a trial for endometriosis utilizing a predominately cellular alternatively than molecular approach, looking for abnormalities successful nan full unrecorded cells successful nan play humor of group pinch nan disease. There are differences successful nan amount and style of definite cells successful women who person endometriosis versus women who don’t, explicate Metz and her co-lead Peter Gregersen. “From that operation we tin create a diagnostic,” says Metz.

Rather than tampons, nan Rose task collects samples pinch menstrual cups, truthful it tin get nan full unrecorded cells. (Indeed, nan cognition that play humor is conscionable dormant worldly is wrong.)

So does Katherine Burns, an subordinate professor of biology and nationalist wellness sciences astatine nan University of Cincinnati, who is besides moving connected a trial for endometriosis based connected a different group of cellular abnormalities, and who herself lives pinch endometriosis.

Yet menstrual cup collection, arsenic it stands, could beryllium a barrier. The cups tin beryllium messy, prone to spills and difficult to insert and remove, peculiarly for personification who has pelvic symptom aliases has not had their play agelong (endometriosis starts successful nan teenage years, and nan earlier nan information tin beryllium diagnosed nan better). Developing a much comfortable and little spillable cup is simply a goal, opportunity Metz and Gregersen.

Beyond endometriosis, proponents constituent to respective gynaecological conditions that menstrual humor could thief diagnose – including different disorders of nan endometrium specified arsenic adenomyosis and chronic endometritis, arsenic good arsenic fibroids, polycystic ovary syndrome, and ovarian and endometrial cancers. Many of these conditions besides spell undetected for years and, successful immoderate cases, tin only beryllium confirmed done invasive procedures specified arsenic an endometrial biopsy.

Ultimately whichever method proves to beryllium champion astatine detecting endometriosis and erstwhile it mightiness go disposable to bargain remains to beryllium seen. All require further studies, including successful teens, and nary are yet seeking regulatory approval. (While afloat FDA support is nan golden standard, location is simply a little tightly regulated but still morganatic pathway that allows companies to bring tests to marketplace much quickly.)

Nonetheless, nan bully news for those pinch endometriosis, Burns notes, is that location are aggregate irons successful nan fire. “We are each moving towards nan aforesaid extremity to thief diagnose endometriosis without surgery,” she says. “Do I dream and wish and believe that immoderate of them are correct? You bet.”

Making testing a reality

Beyond endometriosis, immoderate startups and investigation groups are experimenting pinch a drawback container of different conditions and play humor postulation techniques.

German startup Theblood, founded successful 2022, is exploring really to usage play humor collected via a menstrual cup to supply women pinch wellness position reports. It envisages an at-home trial for hormone levels related to fertility, rhythm wellness and perimenopause, typically done via a modular humor draw. It is besides looking astatine inflammation markers pinch nan purpose of identifying patterns that mightiness constituent toward chronic conditions earlier, and has studied utilizing menstrual humor to monitor vitamin levels.

In May, researchers astatine ETH Zürich successful Switzerland unveiled a prototype menstrual pad pinch a nonelectronic sensor that changes colour successful nan beingness of definite proteins successful menstrual humor that could bespeak disease, including perchance cancer.

Then location is Qvin, different eager Bay Area-based startup besides founded successful 2014, which whitethorn beryllium farthest up successful nan title to make menstrual humor testing a reality.

Last year, nan institution became nan first to person FDA support for a typical menstrual pad and trial for women already diagnosed pinch glucosuria to way humor sweetener levels – an A1C trial but utilizing play humor alternatively than humor from a vein. The pad has a typical postulation portion wherever a mini magnitude of humor pools and dries earlier it is mailed successful to Qvin for analysis.

However, Qvin has stopped offering nan trial straight connected its website for nan clip being and pivoted to see a different market: governments and wellness organizations, peculiarly successful nan world south, seeking inexpensive and much convenient ways of detecting diseases for nan millions of women they serve.

“[Using play humor is] nan astir overlooked opportunity successful women’s health,” says co-CEO Sara Naseri. “We tin make it easy for women to get accusation astir what’s going connected successful their body, and get it early.”

Qvin’s opinionated kit and Q-pad for humor sample collection. Photograph: Courtesy of Qvin

But only if Qvin’s pads are capable to trial a menstrual humor sample for much conditions than diabetes. It is trading its pad strategy to investigation institutions and ample healthcare companies to promote nan improvement of much tests, including for endometriosis, and looking into getting further FDA approvals of its own, for illustration a trial for high-risk quality papillomavirus (HR-HPV), which is linked to cervical crab and presently screened for pinch a Pap smear, and different for various sexually transmitted infections (STIs). Indeed, it has already secured support successful Thailand for nan former. A large advantage of nan pad complete tampons aliases cups is it is nan astir wide utilized menstrual merchandise worldwide, says Naseri.

Kate Clancy is simply a biologic anthropologist astatine nan University of Illinois astatine Urbana-Champaign, wherever she is utilizing play humor to study endometriosis lesions, arsenic good arsenic writer of nan book Period, which investigates nan overlooked subject of menstruation. She has watched pinch liking arsenic nan section unfolds. Some of what she sees, she likes – including utilizing play humor to trial for endometriosis. “Conditions that really impact nan uterus I perfectly spot a usage case; it wholly makes sense,” she says.

But she is skeptical of menstrual humor testing wherever a modular humor trial already exists, specified arsenic A1C for glucosuria aliases hormone testing to measure reproductive health. “Why hold until a personification menstruates?” she says, adding that if an statement for nan menstrual humor tests is that they summation women’s entree to healthcare, nan existent reply lies successful addressing nan societal issues that limit access.

She besides raises a broader concern: while diagnostic tests supply clear answers, definitively confirming aliases ruling retired conditions, a activity of caller menstrual blood-based screening tests – which might, for instance, emblem signs of crab aliases STIs successful patient populations – could extremity up being burdensome, adding other steps to corroborate results and perchance needless anxiety.

And she urges be aware astir menstrual humor tests marketed much for wellness and wellness alternatively than aesculapian purposes. Because they are not making aesculapian claims, they are often little regulated and whitethorn waste insights astir hormone equilibrium aliases vitamin levels that person not been clinically validated.

“We are a ways from bully translational work,” Clancy says.

A imaginable stem compartment source

There is simply a “medical miracle” that happens erstwhile a period successful women’s bodies, erstwhile nan endometrial lining that is shed during menstruation regenerates, thickening explosively arsenic caller humor vessels sprout from existing ones, says Thomas Ichim, a intelligence and biotech entrepreneur who co-authored a 2007 paper connected nan find of stem cells successful menstrual blood. It is stem cells successful nan endometrium – immoderate of which slough disconnected into play humor – that thrust that process. “It’s logical to deliberation that you tin usage those cells to stimulate humor alloy accumulation successful personification else,” Ichim says.

In different words, menstrual fluid does not conscionable person diagnostic and screening potential.

The large committedness of stem cells is that 1 time they will beryllium utilized by doctors to regenerate damaged tissue. (To date, virtually all stem cell-based therapies are experimental.) And erstwhile they were first discovered successful menstrual blood, a flurry of investigation began exploring applications for treating gynaecological disorders, among different diseases.

Theoretically, menstrual humor could beryllium a plentiful root of stem cells: donors could springiness by menstrual cup alternatively of undergoing an invasive biopsy to harvest them from bony marrow, arsenic is believe now.

But small of nan first summation successful investigation ever advanced; according to one caller estimate, conscionable 0.25% of nan big stem compartment investigation successful caller years has progressive menstrual blood-derived stem cells. Without a coagulated knowing of their basal utility, these stem cells are apt decades distant from yielding therapies, says Brendan Harley, a insubstantial technologist besides astatine nan University of Illinois astatine Urbana-Champaign (he and Clancy are married).

‘Blokes cringe if you talk astir it successful nan pub,’ says interrogator Caroline Gargett. ‘[But] menstrual fluid has truthful overmuch potential.’ Photograph: Andrew Brookes/Getty Images/Image Source

“Menstrual effluent is an intriguing stem compartment root … but we are not acold capable on to really opportunity much than that,” he says.

Fundamental work, he believes, is being held backmost successful nan US by nan deficiency of backing and that ick factor– that thing related to menstrual humor is seen arsenic dirty. “I deliberation it has permeated folk’s reasoning astir utilizing it for regenerative medicine,” Harley says.

In 2004, interrogator Caroline Gargett published her discovery of stem cells successful nan quality endometrium, mounting nan segment for their later find successful menstrual blood. These days Gargett, who useful astatine nan Hudson Institute of Medical Research successful Australia, uses stem cells from nan endometrium successful her ain work: helping dainty pelvic organ prolapse. She says they person greater regenerative imaginable and longer lived effects than those successful menstrual blood, though getting them requires invasive endometrial biopsy. “A batch of group person conscionable gone, ‘well let’s try,’ pinch stem cells successful play blood, without really understanding” nan intricacies, she says. (For instance, menstrual humor contains a substance of true stem cells and stem cell-like cells, making it much challenging to isolate a pure, reliable sample.)

Yet she envisions an replacement usage for menstrual blood. She would for illustration to turn tiny, personalized models of nan uterine lining for women pinch endometriosis, alleged “organoids”, from nan fragments of endometrial insubstantial successful their play blood. Each woman’s “miniorgan” would beryllium stored successful a ‘menstrual fluid biobank’ and utilized to trial really they respond to different drugs.

“Blokes cringe if you talk astir it successful nan pub,” Gargett says. “[But] menstrual fluid has truthful overmuch potential.”

Funding remains nan biggest hurdle for play humor testing, opportunity those successful nan field. While NGJ and Qvin, nan Bay Area companies, person bagged astir $20m successful backing each since their inception complete a decade ago, it is simply a mini sum compared pinch immense amounts of rate sloshing astir successful Silicon Valley. The Rose task has nary backing successful spot for nan activity of processing a amended menstrual cup. Burns has had to region improvement connected her trial for endometriosis because it is unfunded. Gargett has not yet secured backing for her biobank, though she continues to try.

In a spot of bully news, nan Massachusetts Institute of Technology (MIT) launched a $10m menstruation subject initiative earlier this year. “This is frontier science,” says Linda Griffith, head of MIT’s halfway for gynaepathology investigation and nan initiative’s leader.

Meanwhile, NGJ wants to support nan travel of humor incoming: arsenic nan startup’s CEO Tariyal, not 1 to miss an opportunity, says: “If you’re reasoning astir really you tin contribute, springiness america your tampon.”