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Biotechnology company Qvin has secured approval from the Food and Drug Administration (FDA) in Thailand for its Q-Pad technology.
Q-Pad is claimed to be the first and only menstrual blood diagnostic device.
It has been designed to provide an accessible and non-invasive way to screen for High-Risk Human Papillomavirus (HR-HPV) and increase early detection between physician visits.
Qvin stated that Q-Pad is a new menstrual pad that can be used twice during menstruation to help remove the barriers of traditional pap smear testing, which can be hard to access, expensive and time-consuming.
The new diagnostic device was initially developed to identify biomarkers for HR-HPV. It has now been expanded to identify additional biomarkers and test for inflammation, blood sugar, fertility hormones, thyroid and ovarian reserve.
Q-Pad comprises a removable cotton strip that is sent to a lab for clinical testing. Users receive their laboratory results in the Qvin app.
Qvin CEO and co-founder Dr Sara Naseri 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.”
The company secured the approval in Thailand in partnership with N Health Laboratories and Bangkok Health Research Center (BHRC).
BHRC intends to conduct a 1,500-person comparative study using Q-Pads and PAP smears on HR-HPV.
The findings collected from the trial will be used to further understand the prevalence of HPV and cervical cancer in the country.
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- Source: https://www.medicaldevice-network.com/news/thailand-fda-qvin-q-pad/
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