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FDA Approves First At-home Syphilis Test that Gives Results in 15 Minutes
FDA Approves First At-home Syphilis Test that Gives Results in 15 MinutesOver-the-counter syphilis test kits could soon be available across the US after the Food and Drug Administration (FDA) handed market authorization for NowDiognostics’ first-at-home syphilis blood test kit, allowing the company to sell it to consumers without needing a prescription. The test was approved through the FDA’s de novo pathway, with similar products expected to follow the agency’s 510(k) pathway, which provides a less rigorous approval process.
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