Europe has authorized the first contraceptive that utilizes saliva, eliminating the need for a pill.

      A saliva-based fertility tracker has been granted regulatory approval for contraceptive use in Europe.

      Developed by the Berlin startup Inne, the home-testing device known as the “Minilab” monitors daily fluctuations in progesterone levels, a hormone essential for regulating the menstrual cycle. It is promoted as a non-invasive alternative to hormonal contraceptives like the pill, with early tests yielding encouraging outcomes.

      A year-long clinical trial involving 300 women over 1,500 cycles demonstrated that Inne’s at-home fertility tracker is 100% effective with perfect use and 92% effective with typical use. These rates are comparable to those of the progesterone pill (99% and 92%) and significantly more effective than condoms (98% and 82%), according to NHS statistics. However, it is important to consider that other contraceptive methods have undergone extensive research over several decades, while Inne’s study had a smaller sample size and has not been peer-reviewed.

      Inne’s saliva-based Minilab has been available for years as a fertility tracker to assist women in conceiving, but it has only recently received formal approval to be sold as a medical contraceptive device, following an evaluation by the British Standards Institution, a key regulator for medical devices in Europe.

      Eirini Rapti, founder and CEO of Inne, expressed in an interview with TNW that the technology helps women avoid the side effects associated with hormonal contraceptives, such as birth control pills or IUD implants.

      “Once you stop taking the pill, the first thing you start to do is understand your body—how you feel and how you respond,” Rapti stated. “You begin to experience a decrease in issues like weight gain, migraines, and reduced libido. Suddenly, women realize, ‘Oh, this is what I actually feel like.’”

      Inne is among several tech-focused contraceptive applications and devices that have appeared in recent years, fueled by the demand for hormone-free alternatives to the pill or IUD.

      Period-tracking apps like Flo assist women in monitoring their fertility windows using data from past cycles. Other options, such as Natural Cycles, advance this by identifying cycle phases based on daily temperature readings.

      However, Rapti asserts that saliva testing is more reliable than these methods because it is based on more definitive biological data.

      “Period and temperature trackers depend on patterns or symptoms, but the body isn’t always predictable,” she noted.

      “Temperature can change due to various factors, such as illness or perimenopause,” Rapti elaborated. “Inne focuses on the actual hormone levels occurring each day, making it more precise.”

      The technology behind Inne employs a lateral flow strip akin to those used in COVID-19 or pregnancy tests. Users apply a small saliva sample to the strip, which contains antibodies that bind to progesterone hormones. The strip is then placed into a reading device the size of a matchbox, which takes photos of the strip over a 10-minute period, analyzing how the hormone particles move and react across the strip.

      The reader processes these images using biochemistry and image processing techniques to assess hormone intensity, which is subsequently synced to a companion mobile app. Through this app, users can monitor their hormonal variations throughout their menstrual cycle, gaining insights into fertility, potential contraception, and overall hormonal health.

      After receiving regulatory clearance, Inne’s contraceptive is now available for purchase in Germany and Austria, with plans to extend to the UK later this year.

      The Minilab will be offered via subscription only, starting at €24 per month for a two-year subscription paid in advance. The device has recently been covered by Germany’s largest public health insurer, and Inne aims to broaden coverage to additional providers in the future.

      Ultimately, Rapti aspires to make saliva-based testing an accessible option for women globally. “It might not be the first choice for everyone, but we believe it’s an excellent alternative that empowers women to regain control over their bodies and health.”