Exclusive: At-home spit test certified as a contraceptive in Europe

Euronews

2 days ago

A new at-home spit test appears to be as effective as birth control pills at preventing pregnancy – and it will soon roll out across Europe, Euronews Health has learned.
The device from Inne, a Berlin-based women's health tech company, has been available for years as a fertility-monitoring tool designed to help people boost their chances of pregnancy. Called Minilab, it works by tracking users' progesterone, the sex hormone that plays a role in fertility, via daily changes in their saliva.
Now, Minilab can also be used to prevent pregnancy, after a small study showed the device was 92 per cent effective – about on par with birth control pills, but without any of the side effects.
'Progesterone can be used for conception or contraception,' Eirini Rapti, Inne's chief executive and founder, told Euronews Health in an exclusive interview.
But 'there was no reliable saliva testing' on the market, she said. So Rapti and her team decided to create it themselves.
The British Standards Institution, which reviews medical device manufacturers in Europe, certified Inne's Minilab this month, meaning it can now be sold as a contraceptive device as well as a fertility tracker.
Inne plans to roll out the device in the European Union in September, with sales in the United Kingdom to follow.
The device is part of a new wave of women's health apps that have gained steam in recent years by infusing tech into fertility awareness, in a bid to make these contraceptive methods more effective, scientifically rigorous, and personalised.
Key competitors like Natural Cycles – which, in 2017, became the EU's first certified contraceptive app – rely on temperature readings to track hormonal levels. But Rapti said saliva, as 'hardcore biological data,' is more accurate because it isn't affected by, for example, having a fever or working up a sweat.
Meanwhile, blood tests are considered the gold standard for hormone tracking, but some research indicates saliva could be a promising alternative because it is cheaper, faster, and can be done easily at home.
The Minilab device is fairly easy to use. Around the same time each day, the user spits into a test strip and inserts it into a small, sleek device that measures their progesterone.
That data feeds back into an app, which learns about their hormonal fluctuations over time. That allows it to identify their fertile window, or the approximately six days per month when they are most likely to get pregnant.
'It's similar technology to COVID tests with antibodies, or pregnancy tests,' Rapti said.
In the company's observational study, more than 200 women in Germany used the Minilab for six months. They were advised not to have unprotected sex on days the app said they were fertile, and asked to record their sexual activity.
Eleven women got pregnant, but two were excluded from the analysis for violating the study guidelines. Others had unprotected sex on days the app identified as high risk for pregnancy, Rapti said.
'We did not have a case where our system gave the wrong ovulation day, or the wrong fertile day,' Rapti said.
The findings translate to an effectiveness rate of 92 per cent, meaning that if 100 women used the Minilab as a contraceptive for one year, eight could expect to become pregnant.
That's about the same as birth control pills or the contraceptive patch, and more effective than condoms (82 per cent). But it's far less effective than non-hormonal intrauterine devices (IUDs), sometimes called copper coils (more than 99 per cent).
Notably, the study – which has not yet been published in a peer-reviewed, academic journal – did not include a control or comparison group, so Inne can't definitively prove that the device is what prevented pregnancy.
Other methods of birth control have also been researched for decades, which means it can be difficult to directly compare Inne's results.
But if the findings hold up over longer periods of time and with larger groups of people, it would make Minilab equally effective as Natural Cycles, the only other app-based contraceptive on the European market.
The approach is also not for everyone. Women should not use Minilab if they have irregular menstrual cycles or were pregnant or breastfeeding within the past three months, the company said.
It said women interested in switching from a hormonal contraceptive – such as birth control pills or certain IUDs – should wait at least two months before starting Minilab to allow their hormones to return to natural levels.
Minilab already has thousands of users in Germany, Austria, and Switzerland, Rapti said.
Eventually, she hopes to add testing for cortisol – the stress hormone – as well as testosterone and vitamins, to help women track their health throughout their lives, not only around pregnancy.
'If you have three or four years of data,' Rapti said, 'you can really start building some intelligence'.
People who use cannabis or its synthetic cousin, cannabinoids, are twice as likely to die from heart problems as those who abstain from the drugs, new research has found.
Recreational cannabis use remains illegal in most of Europe, but it is the region's most commonly used drug. An estimated 8.4 per cent of adults – 24 million people – used cannabis in the past year, according to the European Union Drugs Agency (EUDA).
Cannabis is generally stronger and more diverse than in past decades, with users having a choice between smoking marijuana, edibles, cannabis concentrates, and cannabinoids, which are synthetic psychoactive drugs with a high concentration of
Tetrahydrocannabinol (THC), the active ingredient in cannabis that makes people feel high.
That has prompted concern about the potential health consequences of modern cannabis – and the new study, published in the journal Heart, is the latest to show they carry weight.
In addition to the doubled mortality risks, cannabis use is tied to a 20 per cent higher risk of stroke and a 29 per cent higher risk of heart attacks or other types of acute coronary syndrome, which is when blood flow to the heart is severely restricted, the study found.
The findings raise 'serious questions about the assumption that cannabis imposes little cardiovascular risk,' Stanton Glantz and Dr Lynn Silver, researchers at the University of California at San Francisco who were not involved with the study, said in a written comment.
For the analysis, a French research team assessed real-world data from 24 studies conducted between 2016 and 2023.
Most participants were between the ages of 19 and 59, and cannabis users were more likely to be younger and male compared with people who did not use the drug.
Notably, most of the studies were observational, meaning researchers can't say that cannabis use causes heart problems directly. There was also a high risk of bias in most of the studies.
More research is needed to understand exactly how cannabis is linked to heart problems, and whether the risks differ based on the type of cannabis someone uses.
Despite the limitations, the study authors said their analysis is among the most comprehensive yet to probe the possible link between cannabis and heart problems in the real world.
Glantz and Silver pushed for health warnings on cannabis products and protections against secondhand smoke exposure, particularly as countries relax their cannabis laws and the drug becomes more easily available.
'Cannabis needs to be incorporated into the framework for prevention of clinical cardiovascular disease,' they said.