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Articles from NOWDiagnostics, Inc.

First To Know – the only Over-the-Counter Home Test for Syphilis – Will Now Be Available Through the National Alliance of State and Territorial AIDS Directors, Building Healthy Online Communities and the TakeMeHome Initiative
NOWDiagnostics, Inc. (NOWDx), a leader in developing over-the-counter (OTC) and point-of-care (POC) diagnostic tests, proudly announces that its First To Know® Syphilis Test has joined the innovative TakeMeHome initiative. In collaboration with NASTAD (National Alliance of State and Territorial AIDS Directors) and Building Healthy Online Communities (BHOC), this partnership addresses the growing syphilis epidemic by expanding access to in-home testing and empowering individuals with discreet, accurate and private solutions. Eligible consumers can now order a free First To Know Syphilis Test from the TakeMeHome initiative and have it delivered discreetly to their home.
By NOWDiagnostics, Inc. · Via Business Wire · January 22, 2025
NOWDiagnostics Responds with Countersuit Against Frivolous OraSure Claims
NOWDiagnostics, Inc. (NOWDx), a leader in developing over-the-counter (OTC) and point-of-care (POC) diagnostic tests, filed a claim on Jan. 13 against OraSure Technologies (OraSure), asserting breach of contract, theft of a non-public device, misappropriation of trade secrets, unfair competition, and other violations of state and federal law for damages in federal court in the Eastern District of Pennsylvania. NOWDx is seeking compensatory and punitive damages and payment of attorneys’ fees, among other legal remedies.
By NOWDiagnostics, Inc. · Via Business Wire · January 13, 2025
NOWDiagnostics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, announced today that Robert Weigle, Chief Executive Officer, will present the Company’s vision and commitment to advancing the field at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 14 at 5:00 p.m. PST.
By NOWDiagnostics, Inc. · Via Business Wire · January 7, 2025
First and Only In-Home Test for Syphilis Now Available to Consumers through Major Retailers and Public Health: NOWDiagnostics Launches First To Know® Syphilis Test Across the U.S.
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that its First To Know® Syphilis Test—a key tool in syphilis prevention—is now available for purchase nationwide. The first-of-its-kind, self-directed rapid test provides in-home results in 15 minutes with as little as a drop of blood, offering individuals an accurate, easy-to-use, and private way to test for syphilis. First To Know® is the only syphilis test in the U.S. with FDA marketing authorization for OTC use, and it can now be purchased online on Amazon and in thousands of major retail, pharmacy, and drugstore locations across all 50 states.
By NOWDiagnostics, Inc. · Via Business Wire · November 19, 2024
NOWDiagnostics and Labcorp Collaborate to Expand Access to the Only FDA-Marketing Authorized Over-the-Counter Syphilis Test in the U.S.
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that Labcorp, a global leader of innovative and comprehensive laboratory services, will be the exclusive U.S. distributor of its First To Know® Syphilis Test in professional and healthcare settings. Through Labcorp’s extensive distribution network and trusted presence in clinical settings, this collaboration will expand access to the syphilis test that provides results in 15 minutes with as little as a drop of blood. Labcorp plans to offer the test to professionals and hospital settings by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.
By NOWDiagnostics, Inc. · Via Business Wire · October 16, 2024
NOWDiagnostics First To Know® Syphilis Test Receives FDA De Novo Marketing Authorization for Over-the-Counter Use
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know® Syphilis Test for OTC use. First To Know® is the first and only rapid syphilis test in the U.S. that provides an in-home result in 15 minutes with a single drop of blood. It has been proven in a clinical study of 1,270 people to be easy to use. The test received marketing authorization from the FDA through the de novo pathway, recognizing it as a novel device for syphilis testing in the United States, distinguishing it from other products on the market.
By NOWDiagnostics, Inc. · Via Business Wire · August 16, 2024
NOWDiagnostics Secures $22.5 Million in Series B Funding
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced it has raised $22.5 million in Series B financing. Led by DigitalDx Ventures, with notable investors including the Labcorp Venture Fund and Kompass Kapital Management, this oversubscribed funding round will be used to drive the commercialization of at-home diagnostic tests, continue developing new diagnostic innovations, expand the pipeline of tests, and support strategic hiring initiatives.
By NOWDiagnostics, Inc. · Via Business Wire · July 9, 2024