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FDA approves menstrual blood diagnostic device in Thailand

The developers say the device could provide an alternative diagnostic test to the Pap smear

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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.

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Researchers to develop portable hormone monitoring device

The device is hoped to help women identify symptoms that could be signs of common female health conditions

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Scientists from Edinburgh’s Heriot-Watt University are working on a new portable device that could help women track and monitor their health and hormones.

The gadget will be smaller than an iPhone and will keep track of the full picture of women’s health, from period symptoms to hormone fluctuations, mood and sleep.

The device is hoped to help women identify symptoms that could be signs of common health conditions, such as polycystic ovary syndrome (PCOS), and alert them when they would need to see a doctor.

The researchers hope it will capture data on a variety of fertility-related hormones, like luteinising hormone, which stimulates ovulation, and others like thyroid-stimulating hormone.

The project, led by Dr Sadeque Reza Khan, a specialist in biomedical devices and sensing in Heriot-Watt’s Institute of Sensors, Signals and Systems, is funded by the Scottish Government.

Improving women’s healthcare

According to the Royal College of Obstetricians and Gynaecologists (RCOG), the waiting list for gynaecology appointments, diagnosis and treatment has soared up to 60 per cent recently, affecting more than half a million female patients.

A study conducted by the RCOG in 2022 shows such delays can significantly affect women’s physical and mental health, as well as their quality of life.

“We’re working on building a device that will be about half the size of an iPhone and completely portable. Women will be able to take it everywhere,” explained Dr Khan.

“Women will be able to test both blood and urine, as well as record symptoms, which will provide the most accurate and real-time picture of their health. The device will transfer key data wirelessly to an app, and share it with a gynaecologist.

“At Heriot-Watt we are working on the hardware development and miniaturisation aspect of the device, which is critical as we envision a portable female health monitoring device which women can carry anywhere and reliably use without any hassle.”

Dr Khan is working with viO HealthTech, whose OvuSense device provides continuous general monitoring of the reproductive cycle, and Dr Ruchi Gupta from the University of Birmingham, an expert in developing biosensors.

Rob Milnes, CEO of viO HealthTech, said: “Our users tell us they want access to personalised health information and insights that can help them make informed decisions about their health not only when issues occur, but to avoid those issues in the first place.

“This project offers the exciting prospect of targeted diagnostics added to our existing monitoring system”

Dr Ruchi Gupta from the University of Birmingham, added: “We have been developing our leaky waveguide (LW) biosensor to measure different types of biomarkers; proteins, DNA, hormones, and even cells.

“Our LW biosensor will be at the heart of the gadget for women’s health monitoring. Our partnership with Dr Khan and viO HealthTech will be a key step in the translation of our LW biosensor from bench to bedside. ”

Concept to commercialisation

The team have already started working on the project and, once they have proof of concept, they want to start focusing on making the device commercially available.

“As well as making sure we meet all regulatory requirements, we need to ensure that women can afford the device,” said Khan.

“We’re focused on making sure we are using affordable, sustainable materials that will make this available to a greater number of women.”

Professor Steve McLaughlin, deputy principal of research and impact at Heriot-Watt University, said: “The development of this device demonstrates how our new centre of excellence will support the creation of ground-breaking technologies that have the potential to revolutionise patient care.

“Bringing together academics and industry experts, we want to accelerate the process of bringing these vital developments to market.

“We already have several research projects underway and the next 12 months are going to be a really exciting time as we showcase our developments on the global stage.”

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Canadian period pain relief company makes first acquisition

The acquisition is hoped to help Somedays improve the range of period care products available on the market

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Lux Perry, founder and CEO of Somedays and Aisle co-founders, Suzanne Siemens and Madeleine Shaw

The Canadian period pain relief company Somedays has acquired the period care brand Aisle in an effort to “redefine” the future of menstrual care.

Lux Perry, founder and CEO of Somedays, has said the acquisition of Aisle would help the company prioritise reproductive health and improve the range of period care products available on the market.

“The philosophy underpinning this acquisition prioritises keeping reproductive health businesses in the hands of those they serve and celebrating an impact-based brand that has been at the forefront of the menstrual health movement for decades,” Perry said.

“It may sound idealistic, but I believe that good business and good values are not mutually exclusive. The strategic aspect of the deal lies in the synergy of the two company’s shared audiences and complementary product lines.”

Suzanne Siemens, co-founder of Aisle, said: “Aisle’s story is deeply rooted in menstrual equity and advocacy.

“As we pass the torch to Lux, we are confident that the vision of universal, sustainable access to menstrual care we’ve championed will continue to flourish for generations to come.”

Aisle co-founder, Madeleine Shaw, added: “This intergenerational union exemplifies a fusion of experience and new energy, breathing fresh life into Aisle’s foundational values of sustainability, transparency and body autonomy that have guided the brand for over three decades.”

Founded by a group of friends with period pain and endometriosis who needed better pain relief options, Vancouver-based Somedays is developing plastic-free products for period pain relief. 

“Somedays is my retaliation for the 20 years I spent being invalidated, dismissed and ignored by a society that told me my pain was normal,” explained Perry.

“I had my first experience with debilitating period pain when I was hospitalised for it at nine years old. For the next 20 years, I was passed from physician to physician, trying to find answers and relief.

“I spent a decade on birth control and countless additional medications to combat the side effects of that. None of it worked. I was finally diagnosed with endometriosis in 2021.”

The company, famous for its viral period pain simulator videos with over three billion views, aims to bring a bold vision for the future of menstrual wellness and expand into menstrual healthcare services.

According to Perry, the acquisition of Aisle has the potential to propel the two companies into an exciting future where innovation and product development take centre stage.

“We envision a revolutionary approach to health that will boldly shape the future of menstrual care,” the founder said.

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Virtual care platform raises US$10m to support women with common gynaecological conditions

Gynaecological health is one of the least prioritised areas of health globally, despite an enormous burden of morbidity and mortality

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Rachel Blank, founder and CEO at Allara

The US virtual care platform Allara has raised US$10m in Series A funding to support women with common hormonal and gynaecological conditions.

Allara is a specialty care platform for women living with complex hormonal and gynaecological conditions, such as polycystic ovary syndrome (PCOS) and endometriosis.

The company aims to pair patients with specially trained doctors and dietitians to fill, what it describes as, a significant gap in women’s healthcare.

Globally, gynaecological health is one of the least prioritised areas of health, despite an enormous burden of morbidity and mortality.

Research shows over one in three women live with a chronic condition, such as polycystic ovary syndrome (PCOS), endometriosis, or hypothyroidism.

Despite this, women report years of suffering and go as many as 10 years undiagnosed. These conditions often cause complications such as infertility, high-risk pregnancies, obesity, and diabetes, as well as delayed diagnoses and treatments.

“Women’s health is often misperceived as limited to pregnancy and fertility, failing to acknowledge the intricate web of health conditions that affect women’s daily lives and long-term health,” said Rachel Blank, who founded Allara after her own difficulty navigating a PCOS diagnosis without sufficient medical support.

“At Allara, we finally take the burden off the patient to navigate a siloed care system and empower her with a whole-body, preventative approach to her health.”

The company’s latest round was led by Google Ventures, with participation from Great Oaks Venture Capital, Humbition, Vanterra, Gaingels, and individual investors, including Tom Lee (One Medical) and Maggie Sellers.

The start-up will use the new funds to expand access to care by extending its insurance coverage, launching partnerships with health systems and conducting clinical research.

Blank said: “We are grateful for the support of GV and our dedicated partners to scale our operations and extend this vital care offering to women nationwide.”

Frédérique Dame, GV general partner, added: “Women of reproductive age have complex hormonal care needs, and Allara raises the bar for clinically driven, personalised hormonal healthcare.

“Allara has built a brand and community that hundreds of thousands of patients trust, and we’re excited to support CEO Rachel Blank and the team as they provide women with compassionate, modern healthcare.”

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