An Israeli company is launching the world’s first pregnancy test that delivers results from saliva samples, using technology it developed for COVID-19 tests.
Salignostics, a Jerusalem-based medical startup, 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 quickly move forward on the pregnancy test.
The company announced Thursday that it will start to commercialize its SaliStick test early next year, which has 95 percent sensitivity when women use it after they have missed a period.
The company has successfully completed clinical trials in Israel on more than 300 women — both pregnant and non-pregnant — and has begun the approval process with America’s Food and Drug Administration and for the European Union’s CE Mark.
“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 to detect the virus, there was of course a more urgent need to invest in this technology,” Dr. Guy Krief, co-founder and deputy CEO at Salignostics
“It is deeply encouraging that technology that was honed and developed to help us deal with the 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.”
The Salignostics coronavirus test is European Union-approved, and has sold widely in Europe and Africa.
“Saliva is the key to rapid diagnostics for a variety of medical uses,” said Kries. “With SaliStick, we are leveraging the powerful diagnostics abilities we have been able to create from analyzing saliva.”
About the Test
Saliva is a complex fluid which contains markers for several diseases and variety of hormones.
The level of those hormones is significantly lower than in serum/- blood or urine. Therefore, only a sensitive test will allow their detection. When you are pregnant, your body produces the pregnancy hormone, hCG (human chorionic gonadotropin).
A portion of this hormone travels from the blood to the saliva. Levels of hCG continue to increase rapidly during the first 3 months of pregnancy.
Salignostics has developed the unique SaliStick™ pregnancy test. The SaliStick kit can detect even the low levels of hCG in saliva. The kit is based on a lateral flow immunoassay (LFIA). This is the same principle used by other pregnancy tests that
you can find on the market.
When to use the SaliStick™ Test
The SaliStick™ Test can detect hCG (human chorionic gonadotropin) in saliva starting from 1 day after your missed period. You
can use the test at any time of the day (30 minutes after drinking or eating).
A sealed pouch with a Collection handle, Analytical unit and a preservative silica bag (to be tossed away), Instructions for use.