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Home hormone tests for perimenopause lack clinical value 

Oova, Mira, and Everlywell are expanding from fertility to perimenopause tests, but experts question their clinical value.
By admin
Oct 30, 2024, 1:07 PM

Companies like Oova, Mira, and Everlywell entered the FemTech market with at-home fertility diagnostics, equipping people who want to become parents with mail-order lab tests or home hormonal monitoring products to optimize their conception prospects. As perimenopause and menopause are gaining funding and attention, these companies and others are expanding their offerings to provide new insights into a period of a woman’s lifespan that was typically ignored or unmeasured. But do they work? 

FemTech market trends and opportunity

Both the fertility and menopause home diagnostic test companies are betting on two things: one, that the consumerization of healthcare is in their favor, meaning that women will spend money out of pocket, and two, that people want more information about their health for personal decision making. There is data to back these bets: Women are 75% more likely to use digital health tools compared to men. Additionally, women have taken to digital health for spite tracking. Tired of their descriptions of symptoms being ignored during annual exams, women are arming themselves with self-reported, biometric, and lab value data in search of answers to their healthcare questions.  

Targeting women as curious and health-conscious consumers has worked out well for fertility tech companies. There are over 150 fertility companies alive and well per FemHealth Insights 2023 FemTech Landscape report with an estimated $42.23 billion market value as of 2023. Companies helping women identify their fertile window through home diagnostics tests is one slice of this large pie.    

Benefits of home fertility diagnostics 

The medical community understands the basics of a woman’s menstrual cycle, which runs on a relatively predictable cadence, month over month during the fertile years. Assuming that a woman has a “normal” menstrual cycle (around 25-30 days), ovulation tests, which indicate a surge in luteinizing hormone levels (LH) that precedes ovulation are around 99% accurate. These tests are relatively inexpensive – Natalist sells them for $0.83 each, and around 7-10 are needed per cycle. The particularly data-driven consumer can purchase the Mira at-home lab, which runs between $229-298, which tracks LH and additional hormones and the Bluetooth device syncs with a phone app to store that hormone data month over month. The reason these products are successful in the market is because they work. The user experience is straightforward and the data is valid. Users check their urine for an LH surge with the test kits and have sex within 48-72 hours for the best chance of conception.   

The problem with quantifying perimenopause

In contrast to the monthly menstrual cycle, perimenopause does not follow a regular cadence. Perimenopause is a gradual transition to menopause (no menstruation for 12 months) and can last for up to a decade. On average, perimenopause begins in the 40s and American women reach menopause around the age of 51. During perimenopause, the supply of eggs dwindles, production of estrogen becomes inconsistent and ultimately declines to below premenopausal levels once a person has had their final period.  

The perimenopause tests on the market measure some combination of luteinizing hormone (LH), Follicle-stimulating hormone (FSH), progesterone, and estrogen. Startups like Oova and incumbents including Labcorp and Clearblue have all gotten into the perimenopause hormone measurement game. Clearblue’s home urine tests cost around $20 for 5, while Everlywell and Labcorp’s blood tests can cost consumers between $99-$149 a pop.  

Women’s health has been underfunded and under researched since the beginning of time. This lack of institutional knowledge around female bodies can leave women feeling like they are in the dark when it comes to understanding perimenopause, which is a huge transition in not only their fertility, but their sleep, moods, bones, weight, heart health, skin, and more. Of course, women want answers about why things are happening to them and how much longer they will have to endure uncomfortable symptoms. The desire for these answers is the crux of the value proposition of D2C perimenopause hormone tests.  

But here’s the rub. The data from these tests is clinically meaningless.  

The American College of Obstetrics and Gynecology and The Menopause Society guidelines advise clinicians to counsel and treat patients undergoing perimenopause based upon their symptoms, not lab values. I asked Dr. Vivienne Meljen, Obstetrician- Gynecologist in Vancouver, Washington and Menopause Society Certified Practitioner if she would incorporate the data from these home tests into her clinical decision making, and if she would order any of these lab tests for patients. Dr. Meljen shared that “Typically, we do not run tests like these as part of the standard of care in the management of perimenopause/menopause. Testing hormones is unlikely to contribute to symptom management as the treatment is not titrated to hormone levels which can be erratic as a normal part of the transition.”  

Home hormone tests for menopause only capture a moment in time over a multi-year period. It’s like watching two seconds of a movie and thinking you understand the entire plot.  

Instead of spending money on these at-home tests, Dr. Meljen encourages women with healthcare concerns to see a qualified women’s healthcare practitioner for their symptoms to have a full evaluation. She also shared that the Menopause Society maintains a listing of Menopause Society Certified Practitioners (MSCP.)  

Other ways digital health can support women through perimenopause  

Health technology companies can provide women with support through perimenopause in more meaningful ways than selling unnecessary lab tests. Companies like Midi Health, Elektra Health, and UpLiv offer evidence-based education content, telehealth services, and peer communities to support women through the transitional years – many covered through insurance or employer benefits. And as for additional funding to improve our understanding? S.4246 – Advancing Menopause Care and Mid-Life Women’s Health Act was introduced to the U.S. Senate in May of 2024 and includes $275 million to improve research, care, and treatment related to menopause. A step in the right direction.  


Katie D. McMillan, MPH is the CEO of Well Made Health, LLC, a business strategy consulting firm for health technology companies. She is also a curious researcher and writer focusing on digital health evidence, healthcare innovation, and women’s health. Katie can be reached at katie@wellmadehealth.com or LinkedIn.  


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