Qvin Receives its First FDA Clearance for Q-Pad and Q-Pad A1c TestSAN FRANCISCO, Jan. 8, 2024 /PRNewswire/ -- Qvin™, the biotechnology research company that developed the first and only healthcare service that collects menstrual blood samples as an alternative to traditionally collected venous blood draws, today announced FDA clearance of its Q-Pad™ and A1c Test.

2024年1月8日，Qvin首次获得FDA对Q-Pad和Q-Pad A1c测试的批准旧金山™, 生物技术研究公司开发了第一个也是唯一一个收集月经血样的医疗保健服务，作为传统静脉采血的替代品，今天宣布FDA批准其Q-Pad™ 和A1c测试。

The clearance makes it possible for the millions of women in America who live with diabetes to receive monitoring of A1c, using laboratory tests performed on the Q-Pad. More broadly, this marks an opportunity for testing important biomarkers for the more than 80 million people who menstruate in the U.S..

该许可证使美国数百万患有糖尿病的女性有可能通过在Q-Pad上进行的实验室测试接受A1c监测。更广泛地说，这标志着为美国8000多万月经来潮的人测试重要生物标志物的机会。。

Continue Reading

继续阅读

Qvin Q-Pad

Qvin Q-Pad

The traditional methods of blood testing require invasive procedures administered by medical professionals, and those can be time-consuming and expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of people globally have their period every single month.

传统的血液检测方法需要由医学专业人员进行侵入性操作，这些操作可能既费时又昂贵。并不是每个人都有时间、渠道和财务手段来获得血液工作的实验室结果，然而，全球数十亿人每个月都有月经。

And yet, menstrual samples had never previously been explored as a diagnostic source for health information. Qvin proved the clinical relevancy of menstrual blood for a number of important biomarkers. Now, for the first time, menstrual blood can be used to provide insights for people with the Q-Pad and A1c Test, from the convenience of their own home.

然而，以前从未将月经样本作为健康信息的诊断来源进行过探索。Qvin证明了月经血与许多重要生物标志物的临床相关性。现在，从家中的便利性来看，月经血首次可以用于为Q-Pad和A1c测试的人提供见解。

FDA clearance of the Q-Pad and A1c Test, for at-home collection of samples and over-the-counter (OTC) distribution, speaks to the safety and simplicity of the Q-Pad technology..

FDA批准Q-Pad和A1c测试，用于在家收集样品和非处方药（OTC）分发，说明了Q-Pad技术的安全性和简单性。。

'With the first ever FDA-cleared menstrual blood health test, Qvin is paving the way to important new opportunities for women's health and this is just the beginning,' said Dr. Sara Naseri, Qvin Co-founder, Medical Doctor, and scientist. 'We are simplifying routine testing, and freeing up resources that can be used on providing care and ultimately our goal is to make health care much more accessible.'.

Qvin联合创始人、医生和科学家萨拉·纳塞里（SaraNaseri）博士说，Qvin首次通过FDA批准的月经血液健康测试，为女性健康的重要新机遇铺平了道路，这只是一个开始我们正在简化常规检测，并释放可用于提供护理的资源，最终我们的目标是使医疗保健更容易获得。”。

Each Q-Pad includes a removable strip; once the Q-Pad has sufficiently collected a menstrual sample, the removed collection strip is sent to a CLIA-Certified (Clinical Laboratory Improvement Amendments) laboratory for clinical testing. Users receive their results via the free and convenient Qvin app.The Qvin A1c Q-Pad Test Kit measures the average blood sugar over a three-month period, by testing the A1c biomarker for people with diabetes.

每个Q垫包括一个可拆卸的条带；一旦Q-Pad充分收集了月经样本，取出的收集条就会被送到CLIA认证的（临床实验室改进修正案）实验室进行临床测试。用户通过免费便捷的Qvin应用程序接收结果。Qvin A1c Q-Pad测试试剂盒通过测试糖尿病患者的A1c生物标志物来测量三个月内的平均血糖。

It's one of the most commonly used tests to monitor diabetes and pre-diabetes. Blood sugar (glucose levels) can have health impacts, even for non-diabetics. This test allows patients to track their blood sugar.'Utilizing menstrual samples, the Q-Pad can address critical women's health issues that have historically been neglected,' stated Søren Therkelsen, Co-founder of Qvin.

这是监测糖尿病和糖尿病前期最常用的测试之一。血糖（血糖水平）可能对健康产生影响，即使对非糖尿病患者也是如此。这项测试可以让患者追踪他们的血糖。”Qvin联合创始人瑟伦·瑟克尔森（sørenTherkelsen）表示，利用月经样本，Q-Pad可以解决历史上被忽视的关键女性健康问题。

'Because of our vertically integrated infrastructure, we will over time be able to deliver healthcare solutions at a significantly lower cost than traditional methods. We are proud to have developed a product that has the potential to vastly improve access to global healthcare.'Qvin, in collaboration with researchers at academic institutions such as Stanford University School of Medicine, has published peer-reviewed research validating other biomarkers that can also be monitored.

“由于我们的垂直集成基础设施，随着时间的推移，我们将能够以比传统方法更低的成本提供医疗保健解决方案。我们很自豪能够开发出一种有潜力极大改善全球医疗保健服务的产品。”Qvin与斯坦福大学医学院（StanfordUniversity School of Medicine）等学术机构的研究人员合作，发表了同行评审的研究，验证了其他也可以监测的生物标志物。

Q-Pad allows individuals to submit specimens directly to the lab and receive reports on key health conditions that often go undiagnosed or misdiagnosed including pre/diabetes, anemia, fertility, perimenopause, endometriosis, and thyroid health.'The research and development that Qvin has undertaken is both highly novel and innovative in helping women better address their health concerns,' said Dr.

Q-Pad允许个人直接向实验室提交标本，并接收有关通常未被诊断或误诊的关键健康状况的报告，包括糖尿病前期/糖尿病、贫血、生育能力、围绝经期、子宫内膜异位症和甲状腺健康。”Qvin进行的研究和开发在帮助女性更好地解决她们的健康问题方面既新颖又创新。

Paul Blumenthal, Professor Emeritus of Obstetrics and Gynecology at Stanford University, and .

斯坦福大学妇产科名誉教授保罗·布卢门撒尔和。