News
FDA approves menstrual blood diagnostic device in Thailand
The developers say the device could provide an alternative diagnostic test to the Pap smear

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.
Cancer
AI could transform ovarian care through personalisation, study finds

AI could transform ovarian care by personalising cancer and fertility treatment, but more clinical validation is needed before routine use.
A systematic review and meta-analysis found AI models showed high diagnostic accuracy for ovarian cancer when combining data such as ultrasound scans and blood test results.
Across 81 studies, AI models correctly identified ovarian cancer in around nine out of 10 cases, with pooled rates of 89 to 94 per cent.
They were also highly accurate at ruling out ovarian cancer when it was not present, with specificity of 85 to 91 per cent.
The analysis also found that explainable AI tools could predict complete surgical cytoreduction in advanced ovarian cancer.
Complete surgical cytoreduction means removing all visible cancer during surgery, which can be an important goal in treatment planning.
The tools achieved a pooled AUC of 0.87. AUC is a measure of how well a model distinguishes between different outcomes, with higher scores showing stronger performance.
In reproductive medicine, AI algorithms helped physicians optimise ovarian stimulation protocols and predict follicular growth during IVF.
Ovarian stimulation is the use of hormones to encourage the ovaries to produce eggs, while follicles are the small sacs in the ovaries where eggs develop.
The review found AI could reliably model ovarian response in IVF with a pooled AUC of 0.81.
However, researchers said challenges remain in translating promising research findings into routine clinical practice.
They identified substantial variation across studies, driven by retrospective study designs, variable AI systems and a lack of standardised validation.
Only 22 per cent of analysed studies reported prospective, multicentre external validation, where models are tested forward in time across multiple healthcare settings.
The authors called for rigorous validation to help close the gap between research and routine clinical practice, alongside standardised methodological and reporting frameworks, smooth integration with clinical workflow and robust governance to support responsible and ethical AI use.
They concluded: “Artificial intelligence is a transformative force in the management of ovarian conditions.
“In gynaecologic oncology, AI enhances every phase of care, from early detection and accurate diagnosis to prognostic stratification and surgical planning.”
In reproductive medicine, AI personalises ovarian stimulation and refines the diagnosis of heterogenous endocrine disorders such as PCOS.
PCOS, or polycystic ovary syndrome, is a hormonal condition that can affect periods, skin, weight and fertility.
Cancer
Three cancer innovators shortlisted for Femtech World Award

Femtech World is delighted to reveal the shortlist for this year’s Women’s Cancer Innovation award.
The award, sponsored by Endomag, will honour a groundbreaking innovation dedicated to the prevention, early detection treatment or ongoing care of cancers that uniquely or disproportionately affect women.
Endomag is a medical technology company devoted to improving the global standard of cancer care.
Its Sentimag system, Magseed marker and Magtrace lymphatic tracer are used by thousands of the world’s leading physicians and cancer centres.
After careful review of this year’s submissions, we are delighted to announce the three shortlisted entries for the Women’s Cancer Innovation Award 2026.

Auria is tackling one of the most stubborn problems in breast cancer screening: the 66 per cent of women who simply don’t participate.
Rather than improving existing imaging pathways, Auria is creating an entirely new access layer: a non-invasive, at-home test that detects protein biomarkers for breast cancer in tears.
Auria’s test, a CLIA-certified Lab Developed Test, has been validated across more than 2,000 patients in multiple clinical studies with collaborators including MD Anderson Cancer Center and Stanford University.
It reports a sensitivity of 93 per cent and a negative predictive value of 98 per cent.

Founded on six years of combined research at the University of Barcelona and UC Irvine, The Blue Box has developed a non-invasive, urine-based test that detects breast cancer by analysing volatile organic compound (VOC) signatures – no radiation, no compression, no imaging facility required.
The test achieves a sensitivity of 88.42 per cent, outperforming mammography by 15 per cent overall, and by 30 per cent specifically in women with dense breasts.
The technology could function as a first-line screening tool in primary care settings, as a complement to mammography for high-density patients, or as an accessible alternative in healthcare systems where imaging infrastructure is limited.

Celbrea is a disposable and affordable thermal screening device that empowers women of all ages to stay on top of monitoring their breast health.
The device aims to add to doctors’ existing standard evaluation protocols with a quick, painless examination. Celbrea does not replace a mammogram but simply provides an additional way to screen for breast disease, including breast cancer.
The device consisting of two disposable pads with photochromic sensors. The pads are self-applied to each breast for 15 minutes.
1188 nano-sensors are embedded within a biocompatible multilayer pad, accurately measuring any temperature differences on the surface of the breast using liquid crystal thermographic technology.
What happens next
The shortlisted entries will now be judge by an Endomag representative who will reveal the winner at a virtual awards event on June 19.
Winners will receive a trophy and will be interviewed by a Femtech World journalist.
Insight
Common cancer marker may play active role in preventing the disease, study finds

Ki-67, a protein used to measure tumour growth, may also help prevent chromosome errors that drive cancer, a study suggests.
The findings could change how scientists view Ki-67, a marker commonly used in breast cancer and other tumours to assess how quickly cancer cells are growing.
Researchers found the protein may help preserve genome stability by maintaining the structural integrity of centromeres, key parts of chromosomes that help ensure DNA is shared correctly during cell division.
The research was led by professor Paola Vagnarelli at Brunel University of London in collaboration with scientists at the University of Edinburgh and the Technical University of Berlin.
Professor Vagnarelli said: “Doctors already measure Ki-67 to see how aggressive a cancer might be. But our results suggest it is actually helping maintain genome stability.
“That means it may be more than a marker. It could potentially also be a therapeutic target.”
The study examined three proteins that attach to chromosomes during cell division and help rebuild the molecular system that tells each new cell what kind of cell it is.
Every human cell carries identical DNA. What makes a liver cell different from a brain cell is which genes are switched on and which are kept inactive.
When a cell divides, that entire system of switches must be rebuilt. The three proteins involved in this process were Ki-67, Repo-Man and PNUTS.
Vagnarelli’s team developed a method that individually removes each protein from a living cell at the precise point of division. Older techniques could not isolate that moment cleanly.
They found that cells rely on all three proteins to reset themselves after division, but each failed in a different way when removed.
Without PNUTS, gene activity spiralled out of control and thousands of genes switched on at once.
Without Repo-Man, cells escaped safety checkpoints that usually stop damaged or abnormal cells from continuing to divide.
“What we didn’t expect was how clean the separation was,” said Vagnarelli.
Each protein fails in its own specific way. There is no redundancy, no safety net. Which means there are three separate points at which this process can go wrong.
“When the system breaks down, cells can emerge with the wrong number of chromosomes. That condition, called aneuploidy, is seen in disorders such as Down syndrome and in many cancers.
“We also found that these chromosome errors can trigger inflammatory signals inside the cell.”
Aneuploidy means a cell has too many or too few chromosomes, which can disrupt normal growth and function.
Inflammatory signals are chemical messages that can make a cell behave as if it is responding to injury or infection.
“These cells behave almost as if they are under attack,” said Vagnarelli.
“The immune response switches on because the genome is unstable.
“That link between chromosome imbalance and inflammation could help explain patterns we see in several diseases.”
The researchers said the findings may help cancer scientists better understand how chromosome instability, loss of gene regulation and cells dividing before they are ready contribute to tumour growth.
They said understanding the normal machinery that prevents these errors may help researchers find ways to push cancer cells into making mistakes they cannot survive.
“We now have a clearer map of the machinery that resets the cell after division,” said Vagnarelli.
“That knowledge gives us a starting point for thinking about new therapeutic approaches.”
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