Women’s health company Proov got the FDA green light for its at-home ovulation testing kit.
Users can send away for the kit and get test strips, which can determine the presence of progesterone metabolite PdG in urine, which is linked to a woman's ovulation cycle.
The test was developed to help women find out if they are ovulating on a regular basis.
In the spring, the company will roll out its mobile app. Currently, the app is in beta. Users are able to take a photo of their test strips and upload them to the app. The app was designed to help show users their progesterone and LH levels, so they will know the best time to get pregnant. It will also graph a users' daily and monthly hormone levels.
The company said it will continue to build its product pipeline in women's health and hinted at a tool for perinatal women.
WHY IT MATTERS
Infertility is a common condition in the U.S. According to the CDC, roughly 12% of women between 15 and 44 have trouble getting pregnant or carrying a pregnancy to term. There are multiple factors leading to infertility issues. Age, smoking, weight gain or loss and stress are associated with a decline in female fertility.
Common conditions, including polycystic ovaries and endometriosis, can also increase a woman's risk of infertility.
THE LARGER TREND
In recent years there has been a drive to give women more information about their reproductive cycles.
In 2018, London-based Concepta Diagnostics release of its myLotus Fertility app and monitoring system, which lets women trying to conceive test their hormone levels at home. It includes a product and app that use luteinizing hormone (LH) levels to help predict when a woman has the best chance to become pregnant. Higher levels indicate ovulation.
Mira has also launched an at-home fertility testing system, which has FDA and CE Mark clearances.
Wearables are also coming into the space. Last May a study published in JMIR found that the Ava fertility wearable was able to use biomarkers, including skin temperature and heart rate, to help predict women’s fertility windows.
ON THE RECORD
“Receiving FDA clearance is a huge, pinnacle moment in our journey at MFB Fertility,” Amy Beckley, MFB Fertility’s founder and CEO, said in a statement. “We created Proov as a means to put the power and knowledge of reproductive health into the hands of women. I myself experienced years of struggling to conceive, multiple miscarriages and a feeling of general lacking within the fertility industry so I decided to leverage my doctorate in pharmacology and expertise in hormone signaling to do something about it which is how Proov ultimately came to be.”