What You Should Know:

你应该知道的：

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Teal Health®

青色健康®

, a women’s health company dedicated to eliminating cervical cancer, today announced a landmark achievement: the U.S. Food and Drug Administration (FDA) has approved the Teal Wand™, marking it as the first and only at-home self-collection device for cervical cancer screening in the United States.

，一家致力于消除宫颈癌的女性健康公司，今天宣布了一项里程碑式的成就：美国食品药品监督管理局（FDA）已批准Teal Wand™，这标志着它是美国首个也是唯一一个用于宫颈癌筛查的家用自收集设备。

– The FDA  approval paves the way for women to have a new, convenient, and effective option for what is commonly known as the Pap smear, directly from the privacy of their homes.

——FDA的批准为女性铺平了道路，让她们在家中就可以拥有一个方便、有效的新选择，来进行通常所说的巴氏涂片检查。

– The Teal Wand™ has demonstrated impressive efficacy, proven to detect cervical precancer 96% of the time, a rate equivalent to clinician-collected samples using a speculum. Designed for individuals aged 25-65 at average risk, the Teal Wand™ will soon be available for direct order via getteal.com. The service includes not just the collection kit but also an end-to-end telehealth support system, providing virtual access to Teal medical providers throughout the screening experience..

– Teal Wand™ 展现了令人印象深刻的功效，被证明在 96% 的情况下能够检测出宫颈癌前病变，这一比例与使用阴道扩张器由临床医生采集样本的效果相当。Teal Wand™ 专为 25 至 65 岁平均风险人群设计，即将通过 getteal.com 开放直接订购。该服务不仅包含采集工具包，还提供端到端的远程医疗支持系统，在整个筛查过程中用户可虚拟访问 Teal 的医疗服务提供者。

Addressing a Critical Gap in Women’s Preventative Health

解决女性预防保健中的一个关键缺口

Cervical cancer is unique in that it is almost entirely preventable with regular screening. Yet, a concerning statistic reveals that more than one in four women in the U.S. are not up-to-date with their recommended screenings. Barriers such as difficulty obtaining time off work, challenges in securing timely appointments, or the discomfort associated with in-clinic pelvic exams often contribute to this gap.

宫颈癌的独特之处在于，通过定期筛查几乎完全可以预防。然而，令人担忧的统计数据显示，美国有超过四分之一的女性没有按时进行推荐的筛查。获取休假困难、难以预约及时就诊，或与在诊所进行盆腔检查相关的不适感，常常是导致这一差距的原因。

The Teal Wand™ aims to overcome these hurdles by offering a comfortable, convenient, and scientifically validated alternative..

青色魔杖™ 旨在通过提供一种舒适、便捷且经过科学验证的替代方案来克服这些障碍。

“The Teal Wand is a preferred alternative, one that has been built with empathy, is driven by science, and designed to make screening easy, so that more women can take control of their health on their own terms,” the company stated.

“翠绿色棒是一个首选的替代方案，它以同理心打造，受科学驱动，并且旨在使筛查变得容易，以便更多女性能够按照自己的方式掌控自己的健康，”该公司表示。

How At-Home HPV Screening with the Teal Wand™ Works

如何使用Teal Wand™进行家庭HPV筛查

Instead of the traditional Pap smear, which has a sensitivity (a measure of accuracy) of around 55%, women using the Teal Wand™ will be testing for the human papillomavirus (HPV). HPV is the virus responsible for nearly all cervical cancers, and Primary HPV testing, with a sensitivity of 95%, is the screening method recommended by current medical guidelines and used by providers in clinical settings.

与传统巴氏涂片法（其敏感性（准确度的衡量标准）约为55%）不同，使用Teal Wand™的女性将检测人乳头瘤病毒（HPV）。HPV是导致几乎所有宫颈癌的病毒，主要的HPV检测方法的敏感性为95%，是现行医学指南推荐的筛查方法，并在临床环境中被医疗服务提供者使用。

The Teal Wand™ simply offers a different, FDA-approved method for collecting the sample. This approval means women can now use the same highly accurate test as in a doctor’s office, but with the convenience and privacy of at-home self-collection..

The Teal Wand™ 只是提供了一种不同的、经FDA批准的样本收集方法。这项批准意味着女性现在可以在家中使用与医生办公室同样高度准确的测试，同时享有在家自采样的便利性和隐私性。

Rigorous Science: Validation Through the SELF-CERV Study

严格的科学：通过SELF-CERV研究进行验证

Teal Health’s FDA approval was strongly supported by its SELF-CERV study, the largest U.S.-based comparative study of its kind. This pivotal research confirmed that samples self-collected using the Teal Wand™ demonstrate the same performance as samples collected by clinicians in a medical setting.

Teal Health的FDA批准得到了其SELF-CERV研究的大力支持，这是美国规模最大的同类比较研究。这项关键研究证实，使用Teal Wand™自我采集的样本与在医疗环境中由临床医生采集的样本具有相同的性能。

Crucially, the SELF-CERV study was designed to reflect the racial, ethnic, and socioeconomic diversity of the U.S. population, underscoring Teal Health’s commitment to clinical excellence, equity, and inclusivity in women’s health research. The study also highlighted strong patient preference for the at-home option: 86% of participants stated they would be more likely to stay up to date with cervical cancer screening if they could do it at home, and 94% said they would prefer to self-collect at home with the Teal Wand™ if they knew it was accurate..

至关重要的是，SELF-CERV 研究旨在反映美国人口的种族、民族和社会经济多样性，彰显了 Teal Health 在女性健康研究领域对临床卓越性、公平性和包容性的承诺。研究还突显了患者对居家检测选项的强烈偏好：86% 的参与者表示，如果能够在家中进行宫颈癌筛查，他们更有可能保持筛查的及时性；94% 的人表示，如果知道 Teal Wand™ 准确无误，他们更愿意在家自行采样。

“As a mom and a woman, I get how easy it is to put your own health last,” said Kara Egan, CEO and Co-Founder of Teal Health. “That’s why this FDA approval means so much; it’s not just about an innovative new product, it’s about finally giving women an option that actually makes sense for their lives – something that can be done quickly and comfortably at home.

“作为一位母亲和女性，我深知将自己的健康放在最后是件多么容易的事，”Teal Health的首席执行官兼联合创始人卡拉·伊根表示。“这就是为什么这项FDA批准意义重大；这不仅仅是一个创新的新产品，而是终于为女性提供了一个真正符合她们生活需求的选择——一种可以快速且舒适地在家中完成的方式。”

Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day.”.

因为当我们让护理更容易获得时，我们帮助女性保持健康，为了她们自己，也为了每天依赖她们的人。”

Availability and Access: Bringing the Teal Wand™ to Women Nationwide

可用性与获取：将Teal Wand™带给全国各地的女性

With FDA approval secured, Teal Health is moving swiftly to make the Teal Wand™ accessible. Kits are scheduled to begin shipping in June, initially launching in California and then expanding nationwide as quickly as possible. Teal Health is also actively working with major insurance providers and plans to offer flexible payment options to help alleviate financial barriers and ensure broader access to this innovative at-home screening method..

随着FDA批准的获得，Teal Health正迅速行动以使Teal Wand™得以普及。试剂盒预计将在六月开始发货，最初在加利福尼亚州推出，然后尽快扩展到全国。Teal Health还积极与主要保险公司合作，并计划提供灵活的付款选项，以帮助减轻经济障碍，确保更广泛地获取这种创新的居家筛查方法。

Women interested in being among the first to know when Teal Health expands to their state can join the waitlist at getteal.com for early access to updates and availability.

有兴趣成为首批在Teal Health扩展到她们所在州时知晓的女性，可以访问getteal.com加入等候名单，以提前获取更新和可用性信息。