NOWDx Submits De Novo Classification Request to the FDA for Its First to Know ™ Over-the-Counter Syphilis Test
SPRINGDALE, Ark., Jan. 9, 2024 /PRNewswire/ -- NOWDiagnostics (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced they have submitted a De Novo Classification Request to the U.S. 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.
- Additionally, the company secured a strategic investment from the Labcorp Venture Fund , marking an important milestone in the company's commercialization strategy.
- NOWDx develops and manufactures "Touch to Test" OTC and point-of-care diagnostic tests that yield results in minutes.
- The development of the 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 ( CDC ).
- "We are excited about the FDA submission as we work to bring this syphilis test to market.