The world’s first saliva-based pregnancy tests developed by a Jerusalem-based startup will soon be on shelves in pharmacies and other retail stores in Israel, Europe, South Africa and the United Arab Emirates.
Salignostics, an Israeli biotech company that developed the pregnancy test based on technology used to make COVID-19 testing kits, said on Wednesday that the SaliStick test kits will be available in these regions early next year. The company said it is in advanced discussions with distributors to deliver the kits in the first quarter of 2023.
The Israeli company, founded in 2016, received European CE certification for SaliStick to be marketed in the European Union as well as approval from the Israeli Ministry of Health. Salignostics is currently in the process of seeking FDA approval in the US.
Last year, the company said it successfully completed clinical trials in Israel on more than 300 women — both pregnant and non-pregnant — and was hoping to soon commercialize the kits. It has since set up a manufacturing facility in the Lavon industrial park in the Galilee in northern Israel with a monthly production capacity of a million units, the company said.
“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 help and wellness for women and families all over the world,” Dr. Guy Krief, co-founder and deputy CEO at Salignostics, told The Times of Israel at the time.
The saliva test is as simple (and likely less messy) as traditional pregnancy tests, minus having to aim all the urine. People taking the test insert one part of the test kit into their mouth for several seconds to collect saliva and into a testing tube, which delivers results in under 10 minutes, according to the company. Like many urine-based tests, Salignostics’ saliva test can be taken on the first day of a missed period to detect the presence of the pregnancy hormone β-hCG (Human Chorionic Gonadotropin).
A result of two lines likely indicates a pregnancy.
With the test, Salignostics is marking its entry into a global pregnancy testing market that is expected to be valued at nearly $2 billion by 2030.
The Israeli company was founded by a team of researchers at the Hebrew University of Jerusalem who have focused on saliva as a key diagnostics indicator.
In addition to Salignostics’s SaliStick and COVID-19 tests, which have sold widely in Europe and Africa, the company also sells diagnostic kits for the detection of malaria cardiac risk, and an intestinal bacterial infection called Helicobacter pylori, among others.
“Saliva is the key to rapid diagnostics for a variety of medical reasons. It is the only non-invasive, easy and hygienic means to detect hormones, viruses and even diseases,” said Professor Aaron Palmon, co-founder of Salignostics, in a statement on Wednesday.
“With SaliStick, we leverage the powerful diagnostics abilities we have been able to create from analyzing saliva. This product completely removes the need for blood and urine samples when testing for pregnancy,” he said.
During the development of the SaliStick tests, the company raised some $16 million in capital from private investors and received four grants from the Israel Innovation Authority. Salignostics said it was now raising additional capital to support sales, marketing and R&D operations.