Exciting news! FDA has cleared Qvin’s Q-Pad™ Menstrual Blood Test, a revolutionary, non-invasive test. This groundbreaking advancement empowers millions of women to monitor their health markers conveniently at home, securing a much-needed milestone for FemTech and women’s health.

FDA-cleared innovation for women’s health and accessibility

Qvin, a leading biotech firm, achieved FDA clearance for Q-Pad™, a revolutionary non-invasive menstrual blood test. This innovative test heralds a significant breakthrough for women, providing the means for millions to effortlessly track their health indicators in the comfort of their homes.

Qvin’s visionary strategy not only transforms health monitoring but also tackles longstanding challenges in women’s health, ushering in a paradigm shift towards more inclusive and accessible healthcare solutions. This clearance empowers millions of women managing diabetes to conveniently track their A1c levels through laboratory tests conducted with the Q-Pad.Dr. Sara Naseri, Co-Founder and CEO at Qvin, highlighted the monumental shift in healthcare accessibility, stating:

“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.” 

The doctor explained how the team is streamlining routine testing, liberating resources that can be redirected toward delivering care. Ultimately, their goal is to enhance accessibility to healthcare.

“The icing on the cake? The Q-Pad is so novel that the FDA had to create an entirely new product category for us which, appropriately, has a code starting with ‘Q’”

Conventional blood testing methods usually require invasive procedures administered by medical professionals, and they are frequently time-consuming and costly. In contrast, Qvin’s methodology leverages a universal biological process experienced by billions globally: menstruation.

Søren Therkelsen, Qvin Co-founder, underscored the technology’s capability to tackle overlooked women’s health concerns, emphasising: “Utilizing menstrual samples, the Q-Pad can address critical women’s health issues that have historically been neglected. Because of our vertically integrated infrastructure, we will overtime be able to deliver healthcare solutions at a significantly lower cost than traditional methods.”

Q-Pad Operational Functionality

The Q-Pad includes a detachable strip designed for menstrual sample collection, which is then sent to a CLIA-certified (Clinical Laboratory Improvement Amendments) laboratory for clinical testing. Integration with the Qvin app, known for its user-friendly interface, ensures rapid and convenient delivery of the test results.

Positioned as an essential tool, the Qvin A1c Q-Pad Test Kit facilitates the monitoring of blood sugar levels over a three-month period. This proves particularly beneficial for individuals managing diabetes, offering valuable insights even for non-diabetics regarding the health impacts of their blood sugar levels.

“Our first clearance is in particular around the A1c test,” explained Dr Naseri. “We can confidently report that the testing of menstrual blood using the Q-Pad is as precise as if the sample was taken at your doctors offices from a venous blood draw.”

Additionally, Qvin’s collaborative research, conducted in partnership with esteemed institutions like Stanford University School of Medicine, has not only validated the efficacy of menstrual blood for monitoring various biomarkers but has also unlocked possibilities for diagnosing and managing conditions often underdiagnosed or misdiagnosed. These conditions encompass anemia, fertility issues, perimenopause, endometriosis, and thyroid health.

Dr. Paul Blumenthal, actively engaged in multiple Qvin publications, underscores the groundbreaking and inventive nature of this research. He highlights the Q-Pad’s potential not only in screening for reproductive hormones but also in detecting Human Papilloma Virus (HPV), playing a crucial role in global cervical cancer prevention initiatives.

About Qvin:

Qvin, deriving its name from the Danish word for women, is on a mission to empower menstruating individuals by introducing the Q-Pad, a non-invasive and globally accessible solution. The Q-Pad transforms menstrual blood into valuable lab reports, offering insights into conditions like pre/diabetes, anaemia, fertility, perimenopause, endometriosis, and thyroid health.

Med-Tech World spotlights FemTech innovation

Med-Tech World not only spotlights impactful events worldwide but actively commits to advancing women’s health. By hosting events with expert panels, we carve a space where the spotlight belongs entirely to the professionals, fostering insightful discussions and driving innovation in women’s healthcare. Last October, the ‘Women in Healthcare – Leading the FemTech Revolution’ discussion panel captivated the ultimate day of the thrilling Malta Summit.

Moderated by Aline Noizet, the founder of Digital Health Connector, the Mediterranean Conference Centre in Valletta was graced by industry luminaries such as Elina Valeeva, CEO at Essence Labs and Global Program Director of Women in Tech and Ana Garcia Poyo, CEO & Cofounder of Prefree.

Catch the full panel discussion here!