NowDiagnostics submits FDA de novo request for OTC syphilis test

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NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.

The First to Know test is an at-home lateral flow immunoassay that uses a fingerstick whole-blood sample to provide results within 10 minutes.

Syphilis, a sexually transmitted infection formerly considered to be on the wane, is globally resurging, with reported cases in the U.S. having increased 74% between 2017 and 2021, according to the U.S. Centers for Disease Control and Prevention (CDC). The CDC also reported a tenfold increase over a decade in cases of congenital syphilis, which can result in miscarriage, stillbirth, infant death, and lifelong medical issues. Syphilis can result in serious and even life-threatening complications.

In addition, NowDiagnostics has announced that it is currently completing a $15 million series B funding round; furthermore, the company has received a strategic investment from the Labcorp Venture Fund.

"We are excited about the FDA submission as we work to bring this syphilis test to market. This test will meet the consumer's demand for faster, more affordable, and accessible tests in the privacy of their home," Rob Weigle, CEO of NowDiagnostics, said in a statement. "We are also pleased to have Labcorp as an investor and strategic partner as we begin to launch the first of many OTC tests."

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