World’s First Rapid Saliva-Based Pregnancy Test Set for Multi-Country Launch
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By LabMedica International staff writers Posted on 09 Nov 2022 |
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Image: SaliStick is the first pregnancy test that does not require urine (Photo courtesy of Salignostics)
Saliva contains over 5,000 identified proteins. With significant overlap to blood, saliva is considered the second most important body-fluid for diagnostics. Now, the world’s first saliva-based pregnancy test is all set to arrive in stores across Europe, South Africa, United Arab Emirates, and Israel in the first quarter of 2023. By analyzing saliva, the test completely removes the need for blood and urine samples when testing for pregnancy.
Salistick from Salignostics (Jerusalem, Israel) is the first rapid saliva-based pregnancy test with a new and improved user-experience, and high accuracy for early pregnancy detection. The kit is based on the company’s revolutionary technology which opens the door for a sensitive detection of the pregnancy hormone β-hCG in saliva. The simple, easy to use test can be done anywhere, at any time, without the need for a restroom and delivers accurate results in no more than 10 minutes.
Salistick has already been approved by the European CE certification and has received Medical Devices and Accessories approval from Israel’s Ministry of Health. Salignostics has also completed a 510(K) initial Q-submission of SaliStick to the US FDA. In order to support the commercialization of SaliStick, Salignostics has established a new manufacturing facility in Israel with a monthly production capacity of one million units.
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