The world’s first saliva-based pregnancy diagnostic testing kit, the SaliStick™, will be hitting stores in the UK, Ireland, and South Africa.. No longer is the prospective mother banned to the secrecy of the bathroom to deal with the awkwardness of a home urine testing kit. She can use the SaliStick™ surrounded by her loved ones, in a place of her choice. Abingdon Health, an international developer, manufacturer, and distributor of rapid tests has signed a new distribution agreement with Salignostics for the launch of Salistick™ the first saliva-based pregnancy test in the UK and Ireland. The Salistick™ is set to be launched on the rest of the European market towards the end of 2023.
Salistick™ is a rapid saliva-based pregnancy test that offers women a new and improved user experience, and high accuracy for early pregnancy detection. Salistick™ is based on Salignostics ’ groundbreaking technology which detects the pregnancy hormone β-hCG in saliva. Traditional pregnancy tests are urine-based and Salistick™ offers the ability to test anywhere, at any time, and for the testing experience to be shared with a partner and other loved ones.
The Salignostics Salistick™ test is CE-marked and, subject to regulatory approval in the UK, is anticipated to be available in Q2-2023. Salistick™ will be co-branded with Abingdon Simply Test and will be sold through Abingdon’s direct-to-consumer eCommerce platform and through Abingdon’s other pharmacy distribution channels. https://www.abingdonsimplytest.com/ , costing about £8. The company has concluded a 510(K) initial Q-submission process with the US Food and Drug Administration (FDA).
Another of Salignostics’ s testing kit s, SaliCov, an antigen saliva test for rapid detection of Covid-19, was been selected by the US National Institute of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.
Chris Yates, CEO of Abingdon Health, said: “We are delighted to be distributing Salistick in the UK and Ireland, the first saliva pregnancy test to be launched worldwide. This exciting innovation offers women the opportunity to test for pregnancy in a cleaner, more straightforward, and easier way, and is a long overdue development in the pregnancy testing market. We are excited to be partnering with Salignostics and we look forward to continuing to work with them to bring innovative self-test products to market.’
Dr. Guy Krief, co-founder, and deputy CEO at Salignostics , added: “We are excited to join with Abingdon Health to bring our Salistick saliva-based pregnancy test to consumers in the UK and Ireland. We believe that Abingdon Health is the right partner to bring this revolutionary product to pharmacy shelves throughout the region, allowing for easy and accessible pregnancy tests for women.”
Guy Krief, a co-founder of Israel-based maker Salignostics , said it would enable couples to go through the experience of taking a pregnancy test together for the first time.
Guy Krief added: ‘The concept is so modern and so different to the current way of doing things.’
First, the woman places the foam-tipped stick in her mouth for a few moments, much as one would do with a thermometer. Then she transfers it to a plastic tube, where a biochemical reaction takes place, with a result given in less than ten minutes.
Mr Krief said surveys indicated the method would be popular, with 70 percent of women saying they would opt for a saliva-based pregnancy test compared with 16 per cent who would prefer to stick with the urine-based approach.
One woman who used the SaliStick in trials said it was a ‘joy’ to be able to do the test with her partner present, adding: ‘I didn’t like the idea of having to go to the toilet or bathroom. Urine pregnancy tests can be fiddly and messy.’
Mr Krief said: ‘It’s a lovely idea if you’re trying for a baby to be able to do the test in front of your partner – and hopefully celebrate the goods news together immediately.’
SaliStick can be used to test for pregnancy from the first day of a missed period.
A trial showed that it identified pregnancies 95 percent of the time while giving a false positive reading on fewer than three in 100 occasions. This makes it slightly less precise than urine-based tests — the popular Clearblue brand claims to be over 99 percent accurate.
However, Mr. Krief said they expected to refine their product’s accuracy still further.
Both urine and saliva-based tests work by identifying the presence of human chorionic gonadotropin, or hCG, a hormone specific to pregnancy that helps prepare the uterus for the developing embryo.
Salignostics was found in 2018 at the Hebrew University Medical Center of Jerusalem in Ein Kerem by a group of five like-minded Ph.D.s who identified a prowling need for a cost-effective user friendly means to monitor health well-being and disease onset through non-invasive means. The founders were Prof Aaron Palmon, (president) Dean of The Hebrew University – Hadassah School of Dental Medicine, Dr Omer Deutsch (co-CEO), Dr Guy Krief (co-CEO and cBDO), Dr Raluca Cohen (CSO) and Dr Yoav Neumann (CFOO). The founders all dealt with various aspects of saliva during their doctoral studies. They found that saliva-based diagnostics could match the precision of blood-based diagnostic lab tests.
Salignostics is an Israeli company that since 2016 has been developing technologies that transform saliva into a reliable body-fluid sample for lateral flow immunoassays like this β-hCG Pregnancy Rapid Test. The ingenuity of this technology lies in the ability to overcome physiological obstacles found in the chemical, biological, and physical features of saliva. Salignostics ’ method provides a revolutionary technological platform for saliva diagnostics across a wide range of possible uses.
Pregnancy tests were the most common tests in pharmacies and the Salignostics team set out to develop a saliva-based test to detect pregnancy tests as accurately but not as awkwardly as the current urine–based pregnancy tests.
Salignostics, which raised $8 million in a Series A round last year, also offers a saliva-based test for SARS-CoV-2, called SaliCov.
For further information, see: Salignostics https://www.salignostics.com/
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