Salignostics, an Israeli medical startup, https://www.salignostics.com/ is launching the world’s first pregnancy test that delivers results from saliva samples, the SaliStick, using technology it developed for COVID-19 tests. The very same technology they invented for coronavirus tests is being used to create a device that tells women whether they are expecting.
Salignostics was working on a saliva pregnancy test before the pandemic. It then developed saliva coronavirus tests and suddenly had most of the missing technology it needed, allowing it to move forward on the pregnancy test. The company announced that it will start to commercialize its SaliStick test early next year. The test has a 95% sensitivity when women use it after they have missed a period. This cost-effective, quick, and non-invasive method of detecting pregnancy delivers results in minutes.
Salignostics also has developed a rapid, simple antigen saliva test, SaliCov, which enables at the home COVID-19 screening in only 15 minutes. This unique tool does not require professional personnel or laboratory equipment and can be performed by anyone. SaliCov has been selected by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, https://www.nih.gov/research-training/medical-research-initiatives/radx. The RADx initiative’s goal is to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
Salignostics has successfully completed clinical trials in Israel on more than 300 women, both pregnant and non-pregnant, and has completed thousands of analytical trials. Salignostics is in the advanced stages of receiving the European Union’s CE Mark for SaliStick and has completed a 510(k) submission of the test kit for clearance by the FDA in the United States.
“While we’ve been looking for a few years into the application of saliva pregnancy tests, once COVID came along and we had an opportunity to use saliva to detect the virus, there was, of course, a more urgent need to invest in this technology,” said Dr. Guy Krief, co-founder and deputy CEO at Salignostics. The Salignostics coronavirus test is European Union approved and has sold widely in Europe and Africa. “It is deeply encouraging that technology that was honed and developed to help us deal with one of the worst pandemics is able to be developed further to help contribute to health and wellness for women and families all over the world.”
Saliva contains over 5000 identified proteins that mirror and overlap the physiological state of one’s blood, Salignostics said. Drawing from the same principles used to develop SaliCov, its rapid antigen saliva test kit to detect COVID, SaliStick can detect the pregnancy hormone beta-hcG in saliva and deliver proven and accurate detection rates in early pregnancy.
“Saliva is the key to rapid diagnostics for a variety of medical reasons,” said Dr. Krief. “Quintessentially it is the only non-invasive, easy, and hygienic means to detect hormones, viruses, and even diseases. With SaliStick, we are leveraging the powerful diagnostic abilities we have been able to create from analyzing saliva. We are delivering a product that completely removes the need for blood and urine samples when testing for pregnancy.”
Results are derived exclusively on saliva analysis and are based on a platform technology. As the technology is not biomarker specific, it can be replicated and used for multiple applications and use cases – for example, malaria detection.
Like the SaliCov kit, SaliStick comes individually wrapped for hygienic purposes, and has a handheld applicator for collecting saliva. Once the sample is collected, which takes about one minute, the applicator is placed via a twist-and-click mechanism into the analyzing unit. The results are then displayed on the results window within 10 minutes with two lines indicating a positive result and one line a negative one.
The company will make the results digitally available so they can be shared with loved ones via an app. The cost of the tests, Krief said, will be in the same range as the premium brands of the urine pregnancy tests such as Clear Blue and First Response.
“As an industry, medical science must move forward,” Krief said. “By cracking the code to saliva we are helping advance how medical professionals can perform diagnoses and give individuals the power to make informed decisions about their own health and well-being. With SaliStick, we hope to empower women by making the discovery of pregnancy more dignified and inclusive.”
The annual global market for pregnancy tests is estimated to be over $2 billion with hundreds of millions of tests sold every year. Research conducted by Salignostics shows that over 68% of women surveyed would opt for a saliva-based test over traditional pregnancy detection tests.
Salignostics was founded in 2016 at Hadassah University Medical Center in Jerusalem’s Ein Kerem by a group of five like-minded Ph. D.s who identified a growing need for a cost-effective means to monitor health status, disease onset, progression, and treatment outcome through non-invasive means.
The founders are graduates of the Hebrew University’s Faculty of Dental Medicine who all dealt with various aspects of saliva during their doctoral studies. The Salignostics team observed that pregnancy tests were the most common tests in pharmacies and set out to investigate how pregnancy could be detected via saliva instead of the common blood or urine tests.
They started all the developments and all the technologies, and today have a toolbox of technologies that can be combined and optimized for any application.
For further information, see: https://www.salignostics.com/
Source: The BioTechnology Newsmagazine https://www.biotechnologynewsmagazine.infomeddnews.com/salignostics-salistick-first-saliva-based-rapid-pregnancy-test/ November 10, 2021
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