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Message: [QUOTE="Emma Betuel, post: 4376"] MFB Fertility, the creator of a suite of at-home pregnancy-related hormone tests, announced a $9.7 million Series A round this week. The round follows several milestones for the company including an FDA premarket approval for a progesterone urine test and the rollout of a mobile app. It also gives the company more fodder to build towards its thesis: that at-home hormone testing can save both time, and stress related to “unexplained” infertility. MFB Fertility is more commonly known as Proov – the name of the test developed by owner and CEO Amy Beckley. Proov was founded in 2018, after Beckley had her own struggles with infertility and miscarriage. She found herself classified as “unexplained infertile.” In Beckley’s case, a prescription solved her problem. But the Proov tests, she says, were created for women who also find themselves in the “unexplained” category of infertility diagnoses. [URL='https://journals.lww.com/obgynsurvey/Abstract/2014/02000/Definition_and_Epidemiology_of_Unexplained.17.aspx']Studies[/URL] have estimated that somewhere between 15 and 30 percent of infertility diagnoses worldwide fall into that unexplained category. “It’s just a cop out,” Beckley told TechCrunch. “For a woman to go in and get all the tests and then come out on the other end, and it’s like, oh, yeah, you know, you’re unexplained infertile.” This round was led by Hambrecht Ducera Growth Ventures. It includes participation from SteelSky Ventures, WCC Partners, Lightship Capital, GingerBread Capital, and Portfolia FemTech II Fund. Unexplained infertility can come down to any number of male or female factors. Proov’s flagship test is designed to rule out two problems: the status of ovulation – the process by which an egg is matured and released, and the readiness of the uterus. If you go to a doctor’s office, that doctor might perform a blood test for [URL='https://medlineplus.gov/lab-tests/progesterone-test/']progesterone[/URL], a hormone that helps ready the uterus for pregnancy, and spikes after an egg is released. Proov has developed an at-home urine test to measure a metabolite of progesterone, PdG. External research has validated PdG as a marker of ovulation. [URL='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5689497/']One 2017 review paper[/URL] notes that measuring urine PdG levels over three days was accurate when it came to confirming ovulation, but that no point of care tests using this method had been developed yet. “We developed the first and only FDA- cleared way to measure this at home through urine to understand what we call ovulation quality: is the uterus optimally prepared to have the highest chance of conception?” said Beckley. “We invented it. I literally was the first person to ever have this technology.” Proov has gone through the process of getting the PdG test evaluated and approved by the FDA. It received 510(k) clearance in [URL='https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191462.pdf']February 2020[/URL], because its results were substantially similar to progesterone tests (not direct to consumer) that already exist. Proov’s own clinical trials have suggested that progesterone (and PdG) can also be useful markers of other pregnancy outcomes. The data has yet to be published, but Proov reported data from [URL='https://clinicaltrials.gov/ct2/show/NCT05033366']one trial[/URL] on 54 pregnant women suggesting that women who had two days or more of negative PdG tests during a critical window of time saw increased rates of miscarriage. That data is reported in a [URL='https://www.change.org/p/american-college-of-obstetricians-and-gynecologists-updated-guidance-for-the-use-of-progesterone-to-prevent-miscarriage']change.org petition[/URL] run by the company. The petition is in response to [URL='https://www.ajog.org/article/S0002-9378(19)32762-0/fulltext']American College of Obstetrics and Gynecology guidelines[/URL] suggesting progesterone therapy only be given to women who have already had miscarriages (the company argues that certain tests could also used as impetus for progesterone therapy). PdG tests, though, aren’t the only thing Proov has been up to. The company’s newest product is a “complete” testing product that will provide tests for PdG, Luteinizing Hormone (LH), follicle stimulating hormone (FSH) and an estrogen marker. And, it’s rolled out a mobile app to help users interpret those tests. The app itself is an entry point for more detailed information. Users can submit photos of multiple test strips, which then yield numerical scores detailing certain hormone levels. Those scores are produced via “machine-learning and back-end algorithms,” says Beckley. At the end of the month, the app will provide an ovulation score, says Beckley. Though, critically, the app does more than just provide a number. Offering a test or even a score on its own, she said, led to frustration with users. “Literally, they were writing on our Facebook: ‘I hate this, because I don’t know what to do with a negative result,” Beckley explained. In response the app allows patients to share their results with doctors, speak with experts and also receive certain lifestyle tips (like exercise or nutrition) that might go on to improve progesterone levels through the app. The company is also currently building a supplement platform that would be integrated with the app. The takeaway, per Beckley, is that testing alone isn’t enough. “You have to take that information and gently give her that, but also give her solutions at the same time,” she said. [HEADING=2][B]General Trends [/B][/HEADING] There are a few general trends playing in Proov’s favor. First, is the rise of at-home medical testing. Major diagnostics companies have already announced intent to expand from at-home COVID tests into other arenas. Quest Labs estimates that at-home consumer testing will become a [URL='https://www.medtechdive.com/news/quest-eyes-2b-dtc-testing-potential-to-capitalize-on-breakout-consumer-g/596609/']$2 billion dollar[/URL] industry by 2025. Robert Ford, CEO Of Abbott Labs, for example has also suggested that at-home COVID tests are[URL='https://www.medtechdive.com/news/abbott-quest-look-to-post-pandemic-home-testing-beyond-covid-19/599063/'] “seeding” the idea of at-home tests [/URL]all over the country. If you’re getting used to taking at-home COVID tests, maybe you’ll become accustomed to at-home testing in general. Beckley too has noticed diagnostic company interest in Proov as well. “It’s a lot of the bigger kind of diagnostic companies that are the most interested in what we’re doing,” she said. “Their market is doctors, hospital systems, payers. They don’t understand consumers and what’s buying behavior, so they’re leaning into direct-to-consumer companies like us, that market directly to women.” Fertility testing too – for both men and women – has [URL='https://www.nytimes.com/2020/04/19/parenting/fertility/fertility-startups-kindbody.html']proved to be[/URL] an [URL='https://techcrunch.com/2019/02/28/its-a-new-era-for-fertility-tech/']especially active area[/URL] for startups and investors since about 2019. Crunchbase’s numbers reported an [URL='https://news.crunchbase.com/news/vc-startups-investment-fertility-services-birthrate/']89 percent increase[/URL] in funding for fertility startups between 2020 and 2021, suggesting that the trend is still going strong. [/QUOTE]

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