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NowDx Seeks FDA De Novo Clearance for At-Home Syphilis Test

NEW YORK – Over-the-counter and point-of-care testing firm NowDiagnostics said on Tuesday it has submitted its at-home syphilis test to the US Food and Drug Administration for de novo classification to allow marketing of the test.

The Springdale, Arkansas-based firm said its First to Know syphilis test is a lateral flow immunoassay that uses fingerstick whole-blood samples that can deliver visually read results within 10 minutes. According to NowDiagnostics the test could help address a rising number of syphilis cases in the US.

"This test will meet the consumer's demand for faster, more affordable, and accessible tests in the privacy of their home," NowDx CEO Rob Weigle said in a statement.

The firm simultaneously announced it has received an investment from the Labcorp Venture Fund as part of a Series B funding round that has raised more than $12 million. The round is led by DigitalDx Ventures. Megann Vaughn Watters, VP of new ventures and strategic alliances for Laboratory Corporation of America, added that the firm invests in companies such as NowDx that promise to make healthcare more convenient, accessible, affordable, and personalized.