Qvin menstrual pad blood test bags FDA clearance

A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).

Titled the Q-Pad, the diagnostic is designed as an alternative to traditional intravenous methods of drawing blood for a typical blood test. The aim is to enable women living with diabetes to have easier access to an A1c haemoglobin test.

According to US-based manufacturer, Qvin, it is the first diagnostic system designed in the form of a menstrual pad. It is based on the company’s belief that menstrual blood is a viable source of important biomarkers for a number of conditions, including diabetes.

Sara Naseri, Qvin co-founder said: “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.”

Each Qpad comes with a single removable strip which after use can then be sent to a laboratory for clinical testing, with users receiving results via a proprietary phone app.

The whole testing kit together can measure the average blood sugar of the user over a three-month period, by testing the A1c biomarker.

The US approval comes after the company was able to secure approval to market the Qpad in Thailand in February  2023, where it was given the green light as a means to screen for High-Risk Human Papillomavirus (HR-HPV).

Paul Blumenthal, professor of obstetrics and gynaecology at Stanford University, added: “The research and development that Qvin has undertaken is both highly novel and innovative in helping women better address their health concerns.

“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.”

GlobalData’s Medical Device Intelligence Centre details how the North American market for diabetes care devices was estimated to stand at around $11bn by the end of 2023, with that figure expected to rise to $16.6bn by the end of 2040.

At the same time, the market for in vitro diagnostics in North America stood at around $13bn by the end of 2023, expected to rise to $14.5bn by the end of 2030. It follows after a conference discussing the future of femtech at the London-based GIANT Health conference on December 4, heard how the women’s health sector was growing despite limited investment.

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• Source: https://www.medicaldevice-network.com/news/qvin-menstrual-pad-blood-test-bags-fda-clearance/