NOWDx, a developer of over-the-counter (OTC) and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, submitted a De Novo Classification Request to the US Food and Drug Administration (FDA) for the company’s First to Know at-home syphilis test. Additionally, the company secured a strategic investment from the Labcorp Venture Fund, marking an important milestone in the company’s commercialization strategy.

“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,” says Rob Weigle, CEO of NOWDx. “We are also pleased to have Labcorp as an investor and strategic partner as we begin to launch the first of many OTC tests.”

The development of the NOWDx First to Know syphilis test comes as healthcare experts agree there is a syphilis emergency in the U.S., according to the Centers for Disease Control and Prevention. Once thought to be in decline, syphilis is now resurging at an alarming rate. Left untreated, the consequences can be serious, especially for pregnant women, the company says. 

“In support of Labcorp’s mission to improve health and improve lives, the Labcorp Venture Fund invests in early stage, private companies like NOWDx that are making healthcare more convenient, accessible, affordable and personalized,” says Megann Vaughn Watters, VP, New Ventures & Strategic Alliances for Labcorp.

NOWDx is in the process of completing a $15M Series B round led by DigitalDx Ventures. 

“With the Labcorp investment, along with our current investors and new family offices, the round has closed over $12M to date. We look forward to discussing our vision with the attendees at the J.P. Morgan Healthcare Conference,” added Weigle.

Further reading: Social Support Can Increase Syphilis Testing in Black Sexual Minority Men

“The reality of ‘touch to test’ technology is a game-changer in the large, critical areas of infectious disease and women’s health,” says Michele Colucci, founder and managing partner of DigitalDx Ventures, a Silicon-Valley based diagnostics fund focusing on earlier, less invasive, more accurate, and affordable medical tests enabling access to healthcare for all. “The powerful combination of NOWDx’s proprietary technology and the ability to produce their tests at scale in their state-of-the-art production facility in the tech hub of Bentonville positions the company to be a market leader meeting the growing consumer need.”