At-home fertility test maker Proov is expanding its footprint to Europe after receiving CE marking for its ovulation-confirming test kit.

Proov’s ovulation testing kit got clearance by the FDA for sales in the U.S. last year. The test looks for Pregnanediol Glucuronide (PdG), a metabolite of progesterone produced in urine after ovulation. When elevated levels of PdG are detected in urine, it confirms that successful ovulation occurred and signals that conception is possible.

Before being cleared in the E.U., the Proov test underwent a conformity assessment to demonstrate it meets safety and performance requirements. The test is now available to European users through Amazon.co.uk and proovtest.com, with additional online retailers coming soon.

"We are so excited to finally be able to offer Proov technology to the European market. Our CE approval is testament to Proov's dedication to bringing safe, accurate, and high-quality testing to women everywhere,” Amy Beckley, the founder and CEO of MFB Fertility, said in a statement.

WHY THIS MATTERS

In recent years, Europeans have been having fewer children than in the past. The fertility rate in the E.U. in 2019 was 1.53 live births per woman, down from 1.54 from the year before, and following the general downward trend, according to Eurostat.

A total fertility rate below 2.1 in developed countries like those of the E.U. means there are not enough births to replace the current population, according to Eurostat.

While the reason for the decline in fertility is up for debate, there are several possible contributing factors. For example, roughly one in four couples in developed countries are affected by infertility, according to the World Health Organization.

Another possibility could be diminished economic growth, according to the National Bureau of Economic Research. It suggests that “socioeconomic incentives to delay childbearing; a decline in the desired number of children; and institutional factors, such as labor market rigidities, lack of child care, and changing gender roles,” could be reasons for lower rates of fertility in Europe.

THE LARGER TREND

Outside of getting regulatory clearances for its ovulation test kits, Proov formed a partnership with the U.S. Air Force to give military members and their partners free at-home fertility tests and access to fertility specialists.

Fertility is far from being overlooked in digital health. In fact, Frost & Sullivan says that the femtech market’s growth in the coming years will be driven by areas outside of reproductive health.

In the meantime, companies trying to hack fertility include Lady Technologies, Royal Philips and Merck, Alife and after their acquisition of Modern Fertility, Ro.

There’s even interest in men’s fertility from companies like Legacy and Dadi.