Menstrual Pads as Monitors for Women's Health

Introducing Q-Pad, the groundbreaking menstrual pad by QvinTM that has recently earned FDA clearance—a significant win for women's health diagnostics. This innovative pad, featuring a removal strip for easy blood sample collection, brings exciting possibilities for health monitoring.

For the 13.3 million women dealing with diabetes in the US, Q-Pad provides an over-the-counter, hassle-free solution to monitor A1c levels. This biomarker is a go-to measure used to monitor blood glucose control in diabetic patients as well as prevent the development of this chronic disease in the prediabetic population. A1c, or hemoglobin A1c, reflects the average blood sugar levels over a three-month period. Traditional venous blood tests have been the norm for monitoring blood glucose levels (with  HbA1c levels below 5.7 considered non-diabetic) but can be uncomfortable and time-consuming. However, Q-Pad revolutionizes this process by harnessing the monthly menstruation cycle, allowing women to conveniently gain insights into their health from the comfort of their homes.

Dr. Sara Naseri, co-founder of Qvin, scientist and medical doctor, is enthusiastic about the groundbreaking FDA clearance. She explains, "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. 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 contains handy cotton collection strips called Q-Strips. Simply use the Q-Pad on your heavier period days, slotting it in between your regular products. After use, the Q-Strip neatly goes into the storage container provided. You then place the container into the prepaid return mailer, and it is sent to a CLIA Certified (Clinical Laboratory Improvement Amendments) laboratory for clinical testing. And the best part? You can effortlessly check your results using the free Qvin app. 

In collaboration with Kindbody, Axia Health, Stanford Medical School, and Harvard Medical School, Qvin is actively contributing to advancing women's health research. Their recent groundbreaking study, led by Dr. Naseri and her colleagues, was crucial in gaining FDA approval. In simple terms, the study aimed to determine if using the Q-Pad to collect menstrual blood is as effective as traditional venous blood draws for testing A1c levels.

152 women aged 19-50 participated in the study. The researchers found a strong correlation between A1c levels in menstrual blood samples and those obtained through venipuncture.

Here, correlation describes how closely the values obtained from either sample matched - the closer the number is to 1.0 (a perfect match) the stronger the connection. In this study the correlation value was found to be 0.96, indicating an incredibly high level of agreement! This means that the A1c levels measured from menstrual blood with the Q-Pad are almost spot-on with those obtained through traditional venipuncture  demonstrating that menstrual blood samples are a reliable substitute for the venipuncture method. This robust correlation is likely a key reason why the FDA acknowledged and accepted the Q-Pad as a groundbreaking diagnostic tool. It's not just a number; it's a testament to the accuracy and reliability of this innovative approach to women's health testing.

While the current FDA clearance is only for the A1c biomarker, Qvin’s other published research shows that the Q-Pad can also be used to test biomarkers important in cervical cancer, anaemia, fertility, perimenopause, endometriosis, and thyroid health. Notably, in Thailand, the Q-Pad has gained approval as a screening tool for High-Risk Human Papillomavirus (HR-HPV), contributing to global cervical cancer prevention efforts.

Q-Pad's recent FDA clearance marks a breakthrough in women's health diagnostics—an area often overlooked in medical research. This pioneering approach opens doors to convenient and accessible testing, challenging the status quo in routine diagnostics. Qvin's vision extends beyond regulatory milestones; they are dedicated to advancing women's health, simplifying testing, and making healthcare more inclusive and responsive to every woman's specific needs.

Written by: Tiffany vanLieshout, PhD

Edited by: Bhanu Ramachandran 

References

1. Prevention CfDCa. National Diabetes Statistics Report Website. January 18, 2024. https://www.cdc.gov/diabetes/data/statistics-report/index.html 
2. Diseases NIoDaDaK. The A1c Test and Diabetes. https://www.niddk.nih.gov/health-information/diagnostic-tests/a1c-test#:~:text=The%20A1C%20test%20measures%20the,level%20is%20below%205.7%20percent.
3. Qvin. Qvin introduces Q-Pad: Transforming Women’s Health with FDA-Cleared Lab testing using Menstrual Blood. https://www.prnewswire.com/news-releases/qvin-introduces-q-pad-transforming-womens-health-with-fda-cleared-lab-testing-using-menstrual-blood-302027835.html 
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