Israeli medical start-up Salignostics is set to commercialise the world’s first rapid saliva-based pregnancy test kit, Salistick.
The new cost-effective, non-invasive pregnancy test kit uses technology to detect the saliva-based pregnancy hormone β-hCG and provide accurate results in minutes.
By identifying β-hCG in saliva samples, the new test provides accurate detection for early pregnancy.
Salignostics completed clinical studies in more than 300 pregnant and non-pregnant women in Israel.
The company has concluded a 510(K) initial Q-submission process with the US Food and Drug Administration (FDA) and is in the advanced stages to receive the CE Mark from the European Union (EU) for the test.
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Salignostics Business Development director, deputy CEO, and co-founder Guy Krief said: “Saliva is the key to rapid diagnostics for a variety of medical reasons.
“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 analysing saliva. We are delivering a product that completely removes the need for blood and urine samples when testing for pregnancy.”
The company is set to begin commercialising SaliStick early next year.
For the pregnancy test, the company used the same technology that it used for developing an antigen saliva test, SaliCov, for rapid detection of Covid-19.
SaliCov enables quick and easy screening of large populations and provides results in 15 minutes.
The test received the EU’s CE Mark for marketing throughout Europe and has been selected by the US National Institute of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.