Biotech research company Qvin has announced the FDA clearance of its innovative Q-Pad and A1c Test, marking a significant advancement in women’s health technology. This approval introduces a new method of health monitoring for millions of American women, particularly those living with diabetes, through menstrual blood testing.
The Q-Pad offers a less invasive and more accessible alternative to traditional venous blood draws. This development is particularly beneficial for those who face barriers to standard laboratory testing due to time constraints, financial limitations, or lack of access to medical facilities. The FDA’s clearance of the Q-Pad for over-the-counter (OTC) distribution underscores its safety and ease of use.
“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.”
The Q-Pad includes a removable strip for collecting menstrual blood, which is then sent to a CLIA-Certified laboratory for analysis. Results are conveniently delivered through the Qvin app. The A1c Q-Pad Test Kit, specifically, measures average blood sugar levels over three months, a critical indicator for diabetes management.
“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. “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’s collaborative efforts with institutions like Stanford University School of Medicine have led to the validation of other important biomarkers that can be monitored through menstrual blood. These include markers for conditions like anemia, fertility issues, 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. Paul Blumenthal, Professor Emeritus of Obstetrics and Gynecology at Stanford University, and an author on multiple Qvin publications. “For instance, women seeking to understand their fertility status can soon monitor various reproductive hormones via menstrual blood using the Q-Pad. In addition, published research indicates that the Q-Pad could be a convenient, user-friendly, and efficient way of screening for the Human Papilloma Virus (HPV) as part of global cervical cancer prevention efforts.”
The Q-Pad is part of Qvin’s mission to empower individuals with regular health insights for early detection and effective management of various health conditions. It originated as a tool for identifying HPV biomarkers and has since expanded to test for other significant health indicators.