Israeli start-up launches world's first saliva-based pregnancy test

The cost-effective, quick, and non-invasive method of detecting pregnancy delivers accurate results in minutes.

The SaliStick saliva-based pregnancy test. (photo credit: Courtesy)
The SaliStick saliva-based pregnancy test.
(photo credit: Courtesy)

Salignostics, a Jerusalem-based medical start-up, plans to sell the world’s first and only saliva-based rapid pregnancy test kit, the company said, noting that the cost-effective, quick and non-invasive method of detecting pregnancy delivers accurate results in minutes. Sales of SaliStick are set to begin early next year.

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. The company is in advanced stages of receiving the European Union’s CE Mark for Salistick, and has completed a 510(K) initial Q-submission of the test kit to the FDA in the US.

Saliva contains over 5,000 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 β-hCG in saliva and deliver proven and accurate detection rates for early pregnancy.

“Saliva is the key to rapid diagnostics for a variety of medical reasons,” said Dr. Guy Krief, cofounder and deputy CEO of Salignostics. “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 diagnostics 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.”

The annual global market for pregnancy tests is estimated at 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 kit over traditional pregnancy detection tests.

Salignostics’ COVID antigen saliva test kit received a CE Mark from the European Union for marketing throughout Europe, and is the only saliva-based rapid antigen COVID test included in the US National Institute of Health’s RADx accelerator program. To date, the company has provided hundreds of thousands of kits to Europe and Africa.

The SaliStick saliva-based pregnancy test. (credit: Courtesy)
The SaliStick saliva-based pregnancy test. (credit: Courtesy)

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, corona and even malaria detection.

Salignostics was founded in 2016 at Hadassah-University Medical Center in Jerusalem’s Ein Kerem by a group of five like-minded PhDs who identified a growing need for a cost-effective means to monitor health status, disease onset, progression, and treatment outcome through non-invasive means.

“By cracking the code to saliva, we are helping advance how medical professions can perform diagnoses and give individuals the power to make informed decisions about their own health and well-being,” Krief said.