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Start-up wins FDA breakthrough designation for at-home cervical cancer screening solution

Teal Health aims to make it easier for women to collect cervical cancer screening samples from home

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The US healthcare start-up Teal Health has received breakthrough device status from the US Food and Drug Administration (FDA) for its at-home cervical cancer screening solution.

The Teal Wand is a device that aims to help women collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.

FDA breakthrough, which was awarded after reviewing Teal Health’s midpoint clinical trial data, will grant the start-up priority status when it submits its final study data for FDA review.

The programme helps patients have more timely access to medical devices that could provide more effective diagnosis or treatment of life-threatening diseases and for their potential to benefit populations impacted by healthcare disparities.

With one in four US women not up-to-date on their cervical cancer screening, Teal Health says this FDA breakthrough designation is particularly significant in that it is aimed to increase access for people who rarely or never screen or who can’t undergo a standard exam with the speculum by having an option to screen themselves at-home or in more convenient locations.

Kara Egan, co-founder and CEO of Teal Health, said: “I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognising the importance of Teal’s solution to help close the women’s cervical cancer screening gap in the US.

“The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long.

“This study and breakthrough designation is an important moment for women’s health.”

Late last year, Teal Health followed its initial study with a nationwide clinical trial, titled SELF-CERV, which included 17 leading health organisations and more than 600 participants.

The research was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.

The study, which completed enrolment for its initial FDA indication this month, received an overwhelming response from women, exceeding initial enrolment goals.

Lead SELF-CERV enroler, Clair Kaplan, director of clinical research and principal investigator at Planned Parenthood of Southern New England, said: “The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial.

“We saw upwards of an 80 per cent enrolment rate, which more than met our expectations. I am honoured to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”

Cervical cancer is preventable and is curable 92 per cent of the time. However, it is the second leading cause of cancer death among women aged 20-39 and incidence is increasing among women aged 30-44.

More than half of cervical cancer cases are in people who are not routinely screened, which is in large part due to barriers such as discomfort during the exam, lack of information, time and access.

Studies show that women of all races and socioeconomic levels experience these barriers, with native American, black and Hispanic women resulting in higher under-screened rates.

Self-collection, which has already been adopted in countries such as Australia, is thought to increase access to screening.

Trena Depel, vice president of clinical and regulatory at Teal Health, said: “FDA’s recognition of the Teal Wand as a breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer.

“The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix.”

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Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health and wellbeing.

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Labcorp launches screening test to identify preeclampsia risk sooner

The new screening tool is capable of assessing the risk of preeclampsia sooner, the test maker says

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Labcorp has launched a screening test that can assess the risk of preeclampsia before 34 weeks of pregnancy.

Preeclampsia is a high blood pressure disorder that can develop during pregnancy or postpartum and is a leading cause of maternal morbidity and mortality worldwide.

Roughly one in 25 pregnancies in the US is affected by preeclampsia, which poses an even greater risk for non-Hispanic black women, who experience the condition at a 60 per cent higher rate compared to white women.

In January, Labcorp announced the launch and availability of an FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia during the second and third trimesters.

The first trimester test uses four early pregnancy biomarkers to provide a risk assessment with up to 90 per cent sensitivity, nearly twice the sensitivity of assessing typical maternal history or biophysical factors alone.

According to Labcorp, the test results provide risk identification earlier than traditional symptoms, such as hypertension or protein in the urine, which tend to develop around 20 weeks gestation.

Eleni Tsigas, chief executive officer of the Preeclampsia Foundation, said: “Our organisation celebrates this innovative new test offering.

“Research shows that patients and providers want access to more tools that better predict progression to preeclampsia, especially for those patients with low- to average-risk or those with first-time pregnancies for whom there is some uncertainty.”

Dr Brian Caveney, chief medical and scientific officer at Labcorp, added: “Labcorp is committed to advancing maternal and foetal health through innovative diagnostic and screening solutions.

“This new first trimester blood test is another significant milestone in our mission to improve health and improve lives. By giving healthcare providers another tool to assess preeclampsia risk in their pregnant patients with objective biomarkers, we’re helping to advance prenatal care and improve outcomes for mothers and their babies.”

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People with HIV can be sperm and egg donors

A change in law will allow people with non-transmissible HIV in the UK to donate gametes to partners

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Same-sex couples with non-transmissible HIV will now be able to donate eggs or sperm and become parents.

People with HIV will able to donate their sperm or eggs to their partners, as the law in the UK is updated.

The Human Fertilisation and Embryology Act will be amended via a statutory instrument to allow people with non-transmissible HIV – with a viral load low enough not to pass on – to donate eggs or sperm, known as gametes, as part of fertility treatment to their partners.

Under current rules on IVF, only a male partner with HIV can give their sperm to their female partner and not to anyone else.

The law change will also eliminate extra screening costs for female same-sex couples undertaking reciprocal IVF treatment.

The government says this is part of wider work to improve access to IVF for everyone and ensure same-sex couples have the same rights as a man and woman when trying to conceive.

“These changes will allow more people to fulfil their dream of becoming parents,” said UK health minister, Maria Caulfield.

“We have changed the law to ensure equality for people living with HIV when accessing IVF, allowing them to donate their eggs and sperm.

“In addition, the change will allow female same-sex couples to access IVF with no extra screening costs, the same as heterosexual couples.”

She added: “These changes will help create a fairer system by removing barriers to accessing fertility care as we have set out in the Women’s Health Strategy.”

The changes to the law will allow people with HIV to donate their gametes to family, friends and known recipients.

The regulations include an updated definition of partner donation to enable female same-sex couples wishing to donate eggs to each other to undergo the same testing requirements as heterosexual couples.

Under current rules, female same-sex couples hoping to conceive via reciprocal IVF must first go through screening for syphilis and genetic screening, such as cystic fibrosis, which can cost over £1,000, while heterosexual couples do not need to undergo this screening.

Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA), said: “The HFEA welcomes the news that legislation regarding partner donation in relation to reciprocal IVF, and gamete donation from those who have HIV with an undetectable viral load, has now been proposed in Parliament.

“Fertility treatment is helping more people than ever to create their family, and everyone undergoing fertility treatment should be treated fairly.

“For known donation from individuals with undetectable HIV, we anticipate that the first clinics may be able to begin to offer this treatment around 3 months following a change in the law.

“We encourage any patients or donors who may be affected by these changes to visit the HFEA website to find out free and impartial information, including about how to choose a fertility clinic.”

Minister for equalities, Stuart Andrew MP, added: “Treatment for HIV has improved significantly, saving countless lives, but the stigma surrounding it persists – a stigma which often prevents people from getting tested and seeking treatment.

“These changes will help to reduce that stigma, making it clear that people with HIV can live full and happy lives. I am delighted by these changes which will enable more people to experience the joy of becoming parents.”

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Portfolia invests total of US$65m into women’s health companies

The platform has invested in 47 femtech start-ups to date

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Trish Costello, founder and CEO of Portfolia

The US venture investing platform Portfolia has announced it has invested a total of US$65m into women’s health companies and solutions.

Portfolia aims to create, educate and support the largest community of women investors in the world.

The company says it was amongst the first to recognise the “immense” potential of women’s wealth, with women’s health at the forefront.

To date, Portfolia has made investments in 112 companies with 47 of those women’s health companies being femtech and active aging specific.

Some of these include Madison Reed, Maven, Everly Health, Bone Health, Veana, Your Choice, Future Family, Willow, Hey Jane, Lighthouse Pharma, L-Nutra and JoyLux.

The total companies Portfolia has invested in are estimated to serve over 102 million customers in 115 countries worldwide.

These companies have a combined value of over US$17bn, with over US$1bn in revenue and 10,000 employees worldwide.

According to Portfolia, almost 70 per cent of these businesses are led by female CEOs, and 49 per cent are led by BIPOC individuals.

“At Portfolia, we believe in the power of activating our wealth for returns and impact,” said Trish Costello, founder and CEO of Portfolia.

“Today, women in the United States have unprecedented access to wealth – with over US$25tn of wealth in the US and almost 50 per cent of it owned by women.

“This wealth is power – power to create financial change and invest in the companies and businesses that matter to us and meet our needs/desires.”

She added: “Our commitment goes beyond traditional venture capital – we’re pioneering change, saving lives, and creating opportunities for all, while creating the most powerful community of women investors globally, and the first to activate our wealth to shape the future of healthcare.”

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