At-home fertility test kit maker Proov expands to EU after landing CE clearance
By: Colorado BioScience Association Date: 06/25/2021
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.
Find out more in the Mobile Health News article.