FDA Grants Marketing Authorization to NOWDiagnostic’s At-Home Syphilis Test

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FDA granted marketing authorization to NowDiagnositics for its at-home, over-the-counter syphilis test.¹ According to the agency, the results of the First To Know Syphillis Test should not be considered as an official diagnosis of the disease and that any patients who get a positive result should follow-up with additional testing to confirm the results.

In a press release, FDA’s acting director of its Center for Devices and Radiological Health Michelle Tarver, MD, PhD, said, “We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home. Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection."

NOWDiagnostics first submitted the test for De Novo Classification in January of this year.² At the time, the company’s CEO Rob Weigle said, “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. We are also pleased to have Labcorp as an investor and strategic partner as we begin to launch the first of many OTC tests."

Labcorp’s vice president of new ventures and strategic alliances Megann Vaughn Watters added, “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.”

In July of this year, NOWDiagnostics announced that it had secured $22.5 million in series B funding.³ Notable investors include Labcorp Venture Fund and Kompass Kapital Management.

In a press release issued at the time, Weigle said, “We are thrilled to have the strong support of our investor group, which spans both new and returning participants. This oversubscribed round is a testament to our technology platform and mission. Testing is one of the most crucial tools in preventing the spread of infection and ensuring the well-being of public health. We are committed to making accurate, easy-to-use, and affordable at-home tests available to all."

Kompass Kapital Management’s vice president of portfolio management and investment originations Seth Auld also said, “This investment in NOWDx underscores our confidence in their visionary leadership and commitment to providing diagnostic innovations that could save lives. The importance of at-home testing cannot be overstated, as it enhances access to essential personal health information quickly to make more informed decisions for one’s health. We look forward to witnessing the impact of their pioneering technology on health outcomes and the subsequent impact this technology will enable."

Source

1. FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis. U.S. Food and Drug Administration. August 16, 2024. https://www.prnewswire.com/news-releases/fda-marketing-authorization-enables-increased-access-to-first-step-of-syphilis-diagnosis-302224381.html
2. NOWDx Submits De Novo Classification Request to the FDA for Its First to Know™ Over-the-Counter Syphilis Test. NOWDiagnostics. January 9, 2024. Accessed August 16, 2024. https://nowdx.com/blogs/news/nowdx-submits-de-novo-classification-request-to-the-fda-for-its-first-to-know-%E2%84%A2-over-the-counter-syphilis-test
3. NOWDiagnostics Secures $22.5 Million in Series B Funding. NOWDiagnostics. July, 2024. Accessed August 16, 2024. https://nowdx.com/blogs/news/nowdiagnostics-secures-22-5-million-in-series-b-funding