The COVID-19 pandemic has accelerated development of rapid, point-of-care diagnostics, not just in the US, but around the world. One potential game changer may revolutionize the kind of home test women who miss a period use to determine if they’re pregnant. Using COVID-19 detection technology to fertilize an idea gestated before the pandemic, Israeli medical start-up Salignostics recently announced the world’s first pregnancy test based on saliva samples.
In addition to being easy to detect and store, saliva contains biomarkers that can be used for early detection of different diseases and medical conditions, making it ideal for development of simple, noninvasive multiplexed assays that can be performed quickly at the point of care. One example of a useful biomarker found in saliva is beta-human chorionic gonadotropin (β-hCG) found in plasma and urine, measurement of which can be used to detect levels of hormones associated with pregnancy.
Jerusalem-based Salignostics set out to use its proprietary saliva-based hormone detection technology to develop a home test for early pregnancy detection. But when the pandemic arrived, Salignostics pivoted to COVID-19 testing. Yet, a funny thing happened along the way. In developing its SaliCov rapid antigen test for COVID-19, which has received CE marking from the European Union, Salignostics uncovered the missing piece it needed to bring the pregnancy assay to fruition.
The company reports that its resulting SaliStick test product has 95 percent sensitivity when women use it after they’ve missed a period. The company has successfully completed clinical trials in Israel on more than 300 women—both pregnant and non-pregnant—and is applying for CE marking and FDA approval.