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)
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.
SaliStick- The first saliva based pregnancy test
“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)
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.
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