FDA approves menstrual blood diagnostic device in Thailand

The US biotech company Qvin has announced FDA approval in Thailand for its menstrual blood diagnostic device.

Qvin has developed its Q-Pad technology to provide women with accessible and “non-invasive” diagnostic testing for prevention and early detection.

The company aims to eliminates common barriers to traditional laboratory testing, which can be difficult due to lack of access to care, cultural shame, religious beliefs or financial means.

Thailand, where the device was recently approved, has a population of 30 million women ages 15 years and older who are at risk of developing cervical cancer.

However, the FDA approval is hoped to allow thousands of women to have access to menstrual blood testing and test for HR-HPV.

Q-Pad, a menstrual pad used twice during menstruation, includes a removable cotton strip which is sent to a laboratory for clinical testing. Users are then sent their lab report results through an app or through their healthcare provider.

According to the developers, the device will provide an alternative diagnostic test to the Pap smear, providing an accessible and non-invasive way to screen for HR-HPV.

“As part of our efforts to help women in Thailand prevent cervical cancer, we believe Qvin’s Q-Pad is one of the most innovative ways to screen for HR-HPV earlier,” said Dr Chairat Panthuraamphorn, managing director and CEO at Samitivej Hospital.

“We believe this is a progressive, modern-day approach to cervical cancer prevention and an excellent alternative to Pap smears in our hospital system.”

Dr Sara Naseri, Qvin CEO and co-founder, said: “Receiving FDA approval in Thailand is exciting and contributes to our vision of a world where women do not die from cancers, like cervical cancer, that are entirely preventable if caught early.”

“Approval not only marks a milestone on our journey to move the study of women forward, but it means we can provide accessible testing to millions of people in Thailand to identify HR-HPV earlier to try and eliminate cervical cancer there and look for more countries to follow.”

Dr Paul D. Blumenthal, Professor of obstetrics and gynaecology at Stanford University, said: “It is well known that regular HPV screenings save lives by leading to detection of cervical pre-cancer, which enables patients and providers to treat it effectively before it turns into cervical cancer, a leading cause of death for women globally.

“I’m thrilled that the Q-Pad has been cleared in Thailand, which has high cervical cancer rates.

“Access to testing means users will be able to take control of their health easily and efficiently.”

The FDA Thailand regulatory clearance was completed in collaboration between Qvin, N Health Laboratories and Bangkok Health Research Center (BHRC).

In addition to regulatory clearance, Bangkok Health Research Center plans to conduct a 1,500-person comparative study on HR-HPV using both Q-Pads and Pap smears.

The data collected will be used to further understand the prevalence of HPV and cervical cancer in Thailand and develop strategies to screen for HR-HPV sooner and save lives.