/PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the Visby Medical Women's Sexual Health Test for Over the Counter (OTC) use. This groundbreaking test enables reliable, rapid, and private at-home testing for Chlamydia, Gonorrhea, and Trichomoniasis—the three most common curable sexually transmitted infections (STIs)..

/PRNewswire/ -- 今天，医疗诊断领域的领先创新者Visby Medical™宣布，美国食品和药物管理局（FDA）已授予Visby Medical女性性健康测试非处方（OTC）使用的De Novo授权。这项突破性的测试使得在家中可靠、快速且私密地检测三种最常见的可治愈性传播感染（STIs）——衣原体、淋病和滴虫病成为可能。

The Visby Medical Women's Sexual Health Test

Visby医疗女性性健康测试

The Visby Medical Women's Sexual Health Test represents a significant milestone as the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any indication. Unlike existing home-based STI tests that require mailing samples to a lab, Visby's revolutionary technology provides results directly to users within 30 minutes, utilizing real PCR technology, which is recognized as the gold standard in diagnostic accuracy..

Visby Medical女性性健康检测产品代表了一个重要的里程碑，它是首个获得FDA批准、可用于OTC（非处方）家庭使用的PCR（聚合酶链反应）诊断设备，适用于任何适应症。与现有的需要将样本邮寄到实验室的家用STI检测不同，Visby的革命性技术利用被公认为诊断准确性金标准的真正PCR技术，直接在30分钟内向用户提供结果。

'This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,' said Adam de la Zerda, PhD, Founder and CEO of Visby Medical. 'We've achieved something incredible; our palm-sized, single-use PCR test is simple to use and replaces a bulky, large, expensive laboratory instrument.

“这项批准不仅是Visby Medical的一个里程碑，更标志着医疗诊断领域的变革时刻，”Visby Medical创始人兼首席执行官Adam de la Zerda博士说道。“我们取得了非凡的成就；我们的手掌大小、一次性使用的PCR检测使用简单，取代了庞大、昂贵的实验室仪器。”

After 12 years of development, our device delivers rapid, reliable results directly into the hands of consumers, with unparalleled convenience and privacy. We also built a state-of-the-art, fully automated manufacturing line ready to rapidly scale production in anticipation of growing consumer demand.'.

经过12年的研发，我们的设备能够将快速、可靠的结果直接交到消费者手中，提供了无与伦比的便利性和隐私性。我们还建立了一条最先进的全自动生产线，随时准备快速扩大生产规模，以应对不断增长的消费需求。

Clinical studies involving over 2,000 lay users demonstrated that the Visby Medical Women's Sexual Health Test delivers accuracy comparable to traditional laboratory-based PCR machines, enabling healthcare providers to confidently prescribe treatment based on its results. An intuitive companion app guides users through the entire testing process, including sample collection, test execution and interpretation of results, while delivering a seamless connection to further care options..

涉及超过2000名普通用户的临床研究表明，Visby女性性健康检测的准确性可与传统的基于实验室的PCR机器相媲美，这使得医疗保健提供者能够根据其结果放心地开处方进行治疗。一个直观的配套应用程序引导用户完成整个检测过程，包括样本采集、检测执行和结果解读，同时提供与进一步护理选项的无缝连接。

'The clinical significance of bringing a rapid, highly accurate PCR diagnostic test into the home environment cannot be overstated,' said

“将快速、高度准确的PCR诊断测试引入家庭环境的临床意义怎么强调都不为过，”

Gary Schoolnik

加里·斯库尔尼克

, MD, Chief Medical Officer of Visby Medical. 'Extensive clinical studies validate that this test empowers women to quickly understand what steps to take next, giving them the privacy, control, and confidence to seek the care they need. Importantly, many patients infected with these STIs are non-symptomatic, yet they can still suffer serious long-term health consequences.

医学博士，Visby Medical首席医疗官。“大量的临床研究证实，这项测试使女性能够迅速了解接下来该采取的步骤，让她们在寻求所需护理时拥有隐私、掌控感和信心。重要的是，许多感染这些性传播疾病的患者可能并无症状，但仍然可能面临严重的长期健康后果。

Our test directly addresses this silent epidemic by enabling detection and treatment.'.

我们的测试通过实现检测和治疗，直接应对了这一无声的流行病。

Sexually transmitted infections remain widespread in

性传播感染仍然广泛存在

the United States

美国

. The U.S. Centers for Disease Control and Prevention estimates approximately 1.6 million new Chlamydia cases and more than 700,000 Gonorrhea cases

美国疾病控制和预防中心估计，大约有160万例新的衣原体感染病例和超过70万例淋病病例。

reported

已报告

annually. Trichomoniasis also affects millions of people annually in

每年。滴虫病每年也影响数百万人

the United States

美国

, highlighting the urgent need for rapid and accurate diagnosis.

，突显了快速准确诊断的迫切需求。

The granting of this De Novo marketing authorization positions Visby Medical for significant expansion into the at-home diagnostics market, with plans underway to introduce additional OTC tests addressing respiratory infections, sore throat conditions, urinary tract infections, and other common illnesses.

这一De Novo营销授权的授予使Visby Medical能够大幅扩展到家庭诊断市场，并计划推出针对呼吸道感染、咽喉炎、尿路感染及其他常见疾病的更多非处方测试产品。

'This is just the beginning of our journey into reshaping healthcare through at-home diagnostics,' added Dr. de la Zerda. 'We will soon announce several strategic and commercial partnerships.'.

“这仅仅是我们通过家庭诊断重塑医疗保健之旅的开始，”德拉泽尔达博士补充道。“我们很快将宣布几个战略和商业合作伙伴关系。”

About Visby Medical™

关于Visby Medical™

Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering both physicians and patients to accurately test for infections anywhere, anytime, with laboratory accuracy. The company's proprietary technology platform delivers true PCR results in under 30 minutes through the world's first instrument-free, single-use PCR tests that fit in the palm of your hand.

Visby Medical 成立于2012年，正在通过使医生和患者能够在任何地方、任何时间以实验室级别的准确性检测感染，彻底改变传染病诊断。该公司专有的技术平台通过全球首个无需仪器、一次性使用的掌上型PCR测试，在不到30分钟内提供真正的PCR结果。

Currently, Visby Medical offers FDA-cleared tests for sexually transmitted infections (STIs), available both in point-of-care settings and now directly to consumers at home, and respiratory infections (COVID-19 and flu), available for point-of-care settings. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets..

目前，Visby Medical 提供经 FDA 批准的性传播感染（STI）检测，既可用于即时医疗场景，现在也可直接供消费者在家使用；同时提供呼吸道感染（COVID-19 和流感）检测，适用于即时医疗场景。Visby Medical 正积极扩展其平台，计划推出覆盖家庭和即时医疗市场的多种未来检测产品。