SPRINGDALE, Ark.--(BUSINESS WIRE)--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.

阿肯色州斯普林代尔市。-（商业新闻短讯）--NOWDiagnostics，Inc.（NOWDx）是非处方药（OTC）和即时护理（POC）诊断测试的开发商，今天宣布，美国食品和药物管理局（FDA）已授予其首个用于OTC的to Know®梅毒测试的上市许可。First To Know®是美国第一个也是唯一一个快速梅毒检测方法。

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..

1270人的临床研究证明，它易于使用。该测试通过从头途径获得了FDA的上市授权，将其视为美国梅毒测试的新型设备，将其与市场上的其他产品区分开来。

Syphilis has resurged at an alarming rate in the U.S. in nearly every demographic group and region, including newborns. According to the Centers for Disease Control and Prevention (CDC), cases increased by 80% to over 207,000 between 2018 and 2022. More than 3,700 cases of congenital syphilis were documented among newborns in 2022—10 times the number diagnosed in 2012.

梅毒在美国几乎每个人口群体和地区（包括新生儿）都以惊人的速度死灰复燃。根据疾病控制和预防中心（CDC）的数据，2018年至2022年间，病例增加了80%，达到207000多例。2022年，新生儿中有3700多例先天性梅毒病例，是2012年诊断人数的10倍。

If untreated, syphilis can seriously damage the heart and brain and cause blindness, deafness, and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death. Often, those with syphilis do not notice symptoms..

如果不及时治疗，梅毒会严重损害心脏和大脑，导致失明、耳聋和瘫痪。当在怀孕期间传播时，它可能导致流产，终身医疗问题和婴儿死亡。梅毒患者通常不会注意到症状。。

“FDA granting De Novo authorization of our First To Know® Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, CEO of NOWDx. “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”.

NOWDx首席执行官Rob Weigle说：“在我国减缓梅毒上升的努力中，FDA批准我们的First-To-Know®梅毒测试的从头授权是不可能的。”。“检测是我们预防性传播感染传播的最重要工具之一，消费者现在有史以来第一次可以在家中秘密进行快速简单的梅毒检测，结果只需几分钟。”。

'This FDA authorization is a significant milestone in addressing the syphilis epidemic,' said Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas. 'After reviewing the robust data from the clinical studies, I am impressed with the test's performance. There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations.

阿肯色州前外科医生格雷戈里·布莱索博士（GregoryBledsoe）说，FDA的这项授权是应对梅毒疫情的一个重要里程碑在回顾了来自临床研究的可靠数据后，我对测试的表现印象深刻。迫切需要提高公众对未经治疗的梅毒严重性的认识，特别是在服务不足和边缘化的人群中。

An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment.'.

像这样的家庭测试有可能通过改善及时检测和治疗的机会，极大地影响公众健康。”。

About First To Know® Syphilis Test

About First To Know®梅毒检测

The First To Know® Syphilis Test is a patented buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals suspected of having a syphilis infection. In a clinical study of 1,270 people, the NPA (negative percent agreement) was 99.5%, meaning it correctly identified 99.5% of negative specimens; the PPA (positive percent agreement) was 93.4%, meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests..

First To Know®梅毒测试是一种获得专利的无缓冲液侧流装置，可提供定性快速膜免疫色谱分析，用于检测疑似梅毒感染者的人全血（毛细血管）中的梅毒螺旋体（梅毒）抗体。在一项针对1270人的临床研究中，NPA（阴性百分比一致性）为99.5%，这意味着它正确识别了99.5%的阴性标本；PPA（阳性百分比协议）为93.4%，这意味着与三项FDA批准的实验室测试相比，它正确识别了93.4%的阳性标本。。

First To Know® Syphilis Tests are expected to be available at major national retailers and online in the second half of 2024. *For more information, visit www.firsttoknow.com.

First To Know®梅毒检测预计将于2024年下半年在全国主要零售商和网上提供*有关更多信息，请访问www.firsttoknow.com。

About NOWDiagnostics (NOWDx)

关于NOWDiagnostics（NOWDx）

NOWDx develops and manufactures over-the-counter (OTC) and point-of-care (POC) diagnostic tests. Its patented approach enables virtually any immunological assay to be accurately performed onsite in one step using a small amount of capillary blood, yielding results in minutes. With over 75 patents issued and pending, NOWDx's First To Know® and ADEXUSDx® product lines are available in markets worldwide.

NOWDx开发和制造非处方药（OTC）和即时护理（POC）诊断测试。它的专利方法几乎可以使用少量毛细血管血一步在现场准确进行任何免疫学检测，几分钟内即可产生结果。NOWDx的首个Know®和ADEXUSDx®产品线已在全球市场上推出，已发布并正在申请75多项专利。

Founded in 2013, with headquarters and manufacturing in Springdale, Arkansas, NOWDx envisions a world where people have greater access to in-home testing with results in minutes. The company’s investors include Kompass Kapital Management, DigitalDx Ventures and the Labcorp Venture Fund. NOWDx is committed to changing healthcare by providing accessible, affordable, and accurate testing for all.

NOWDx成立于2013年，总部和生产基地位于阿肯色州的斯普林代尔，它设想了一个世界，在这个世界上，人们可以在几分钟内获得更多的家庭测试结果。该公司的投资者包括Kompass Kapital Management、DigitalDx Ventures和Labcorp风险基金。NOWDx致力于通过为所有人提供可访问、负担得起和准确的测试来改变医疗保健。