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NICE recommends test to help guide chemotherapy decisions in node-positive breast cancer patients

The recommendation has the potential to impact more than 3,000 additional breast-cancer patients in England

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Exact Sciences has announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of its test to help guide chemotherapy decisions for node-positive breast cancer patients.

NICE recommended the expanded use of the Oncotype DX Breast Recurrence Score test for women who have hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage breast cancer involving up to three positive nodes and who have been through the menopause.

The health watchdog confirmed that breast cancer patients who are male and trans, non-binary or intersex may benefit from the test depending on their hormonal profile.

The recommendation has the potential to impact more than 3,000 additional breast-cancer patients in England who will now have access to the test through the NHS.

The new guidance expands upon earlier NICE recommendations for testing patients without lymph node involvement.

Access to genomic testing for patients with lymph node-positive breast cancer addresses the issue of overtreatment with chemotherapy, helping many patients to avoid treatment side effects such as nausea, fatigue, hair loss and potentially secondary cancer.

In addition, expanded reimbursement has the potential to free up resources and capacity within NHS breast cancer services.

Dr Caroline Archer, consultant medical oncologist Portsmouth Hospital NHS Trust said: “This is a practice-changing moment for node-positive patients and the NHS.

“There is an urgent need to target chemotherapy more precisely to those most likely to benefit from it, so that patients can avoid unnecessary side effects.

“The Oncotype DX Breast Recurrence Score result enables us to do this effectively by providing specific information about an individual’s response to chemotherapy. This positive recommendation marks a significant step forward in supporting equitable access to the test across the country.”

While the majority of patients with lymph node-positive early-stage breast cancer receive chemotherapy, research shows that only a minority benefit from the treatment.

The Oncotype DX test is the only test able to identify around 85 per cent of postmenopausal patients whose cancer outcomes are not likely improved by chemotherapy, meaning they can avoid the risk of side effects.

A recent independent UK multi-centre trial led by Prof Simon Holt involving 680 women with lymph node-positive early breast cancer confirmed that using the Oncotype DX test to help guide chemotherapy treatment decisions leads to a substantial reduction in unnecessary chemotherapy, as well as savings for the NHS.

Prof Holt, health and life science, Swansea University & Peony Breast Care Unit, Prince Philip Hospital said: “This decision to recommend the use of the Oncotype DX test to guide chemotherapy decisions in early node positive breast cancer will be of great benefit to our postmenopausal patients and to the NHS.

“The use of the test will reduce the suffering and inconvenience by sparing up to 85 per cent of people unnecessary chemotherapy, which in turn, then reduces the care demands on oncology services.

“It also reduces significantly the cost of treatment so that NHS resources can be redistributed to other medical priorities.”

He added: “Our research has shown that the use of the Oncotype DX test means both clinicians and their patients will have much greater confidence in their chemotherapy decisions.”

Matt Bull, head of Northern Europe (UK, Ireland and Nordics) at Exact Sciences, shared: “We are delighted that more patients with node-positive breast cancer will now also benefit from knowing their recurrence score result.

“We are proud of the potential impact the expanded use of the Oncotype DX test will have — better patient treatment, improved clinical confidence and less pressure on the health service.”

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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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