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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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Fertility

Housing, work and fertility stop Britons having the families they want – research

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Housing, work and fertility pressures are stopping many Britons growing the families they want, new research suggests.

A UK fertility report found that 79 per cent of people surveyed who had tried to conceive in the past five years would like more children than they currently have.

Among parents with one child, that figure rises to 88 per cent.

The report surveyed more than 1,000 people across the UK who had tried for a baby in the past five years.

While birth rates continue to fall, the findings suggest it is not because people no longer want children. Instead, many respondents said external pressures are making it harder to grow their families.

The findings, from wellness brand Wild Nutrition’s Fertility Disconnect report, highlight how financial pressures, fertility struggles and gaps in reproductive health knowledge are shaping modern family life in the UK.

Gail Madalena, fertility nutritional therapist at Wild Nutrition, said: “People often assume fertility begins the moment they decide to try [for a baby].

“In reality, egg and sperm health are shaped months and years earlier.

“By the time someone starts thinking about fertility, their body has already been responding to its environment for a long time.”

Among the biggest barriers, 26 per cent said career progression affected their family plans, 25 per cent cited housing affordability and lack of space, and 52 per cent said they required medical intervention during their fertility journey.

The report also found that almost a quarter of respondents had spent more than two years trying to conceive.

Trying for a baby can take a significant toll on mental health and relationships, especially for those navigating fertility treatment.

According to the research, 38 per cent of respondents said trying to conceive had negatively affected their mental health. That figure rose to 99 per cent among people undergoing fertility treatment.

Julianne Boutaleb is a perinatal psychologist.

She said: “Navigating a fertility journey is about so much more than medical appointments and procedures.

“It’s an emotional marathon that can take a huge toll on your mental wellbeing.

“Sadly, the stats show that 15 per cent of couples going through fertility treatment say their relationship has been irrevocably impaired.”

The report also highlighted the realities of secondary infertility, which affects around one in 20 people, challenging the assumption that having one child means conceiving again will be straightforward.

Researchers found many people felt under-informed about fertility, particularly younger adults.

Ten per cent of Gen Z respondents said they “know nothing” about fertility, while only one in five respondents said they know “a lot” about egg health.

The report also found that 60 per cent of women were unaware of fertility testing options, and one in five Gen Z respondents said they felt uncomfortable discussing fertility, even with their partner.

Around 40 per cent of those surveyed supported fertility education being included in schools, covering topics such as egg health, sperm health and hormonal health.

The report also explored how lifestyle and long-term health may influence fertility outcomes.

Many respondents said they only made changes once they started trying to conceive.

Some 44 per cent improved their diet when trying for a baby, while 32 per cent reduced alcohol intake at that stage.

The report also referenced emerging research that suggests ultra-processed foods and microplastics could have an impact on reproductive health.

While fertility conversations often focus on women, the findings showed male fertility issues are also affecting many families.

Seventeen per cent of respondents cited sperm health issues as a barrier to conception, while male factors contribute to around half of all fertility challenges.

Only one in four men said they would share fertility struggles with friends.

“Many causes of male infertility are entirely treatable yet so often the last resort is the first response,” said Ian Stones, co-founder at Test Him Ltd.

The findings come as UK birth rates remain below replacement level.

The report noted that the UK fertility rate is now 1.41, meaning that on average women give birth to 1.41 children over their lifetimes. The replacement rate, or rate that maintains population numbers, is 2.1.

It also said the average age of mothers has risen to 31, while birth rates are falling across most age groups except among over-40s.

“There is no single fertility story, and it is rarely a simple, linear narrative,” said Dr Zeynep Gurtin, lecturer in women’s health at UCL.

Dr Gurtin added that better fertility education, fairer access to treatment and more open conversations around infertility and pregnancy loss are needed.

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Fertility

Femtech World reveals fertility innovation award shortlist

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Femtech World is thrilled to reveal the shortlist for the Fertility Innovation Award.

The award, sponsored by FinDBest IVF, celebrates a pioneering product, service or initiative that is transforming fertility care and support.

FinDBest IVF is a global B2B digital platform created to simplify and accelerate how IVF and ART manufacturers connect with trusted, pre-vetted distributors around the world.

This year’s nominees represent a remarkable breadth of approaches to fertility care: from clinic-floor breakthroughs to at-home hormone intelligence to truly borderless access.

Three companies made the cut, with each tackling a real, persistent barrier in reproductive health.

Congratulations to the shortlist and many thanks to everyone who entered.

Fertility Innovation Award Shortlist

 

HRC Fertility’s Needle-Free IVF is a pioneering advancement designed to transform one of the most challenging aspects of fertility treatment: daily hormone injections.

Developed by board-certified reproductive endocrinologist Dr Rachel Mandelbaum, this innovative approach reimagines how stimulation medications are delivered during IVF and egg freezing, dramatically improving the patient experience while maintaining the same trusted clinical outcomes.

Inspired by feedback from patients who struggled with the injection process, Dr Mandelbaum adapted an innovative drug-delivery system commonly used in other areas of medicine and applied it to reproductive care

Mira is a hormonal health technology company that provides lab-grade hormone testing and AI-driven insights to help women and couples understand their fertility. 

The platform has already supported more than 200,000 couples on their fertility journeys worldwide, helping over 60,000+ users achieve pregnancy.

For some users, pregnancy rates have reached up to 89 per cent within six months, demonstrating how accurate hormone data can significantly improve fertility outcomes.

 

Founded in 2021 by Marija Skujina, a Certified Fertility Nurse Specialist accredited by the European Society of Human Reproduction and Embryology, with nearly 15 years of clinical experience at one of the world’s top IVF clinics, and having navigated her own fertility journey as a patient, Marija built the clinic she had always wished existed.

Plan Your Baby began with a bold, but simple mission – make best quality fertility and pregnancy available anywhere.

Plan Your Baby has created a new generation fertility and pregnancy clinic with patients accessing expert consultations remotely, while blood tests and ultrasound scans are available at over 450 locations across the UK, eliminating the exhausting travel burden that often forces people to take days off work, relocate appointments, or abandon treatment altogether

What happens now

The shortlist will be judged by a representative from category sponsor FindBestIVF, with the winner announced at a virtual event on June 19.

Winners will receive a trophy and be interviewed by a Femtech World journalist.

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Cancer

Common cholesterol drug shows ovarian cancer promise

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A common cholesterol drug could help weaken a fluid shield that helps ovarian cancer tumours survive, early lab findings suggest.

The findings do not show the drug treats ovarian cancer. But they suggest changing the environment the cancer depends on could make it more vulnerable to existing treatment.

A federally funded study at Duke University School of Medicine found that ascites, a build-up of fluid in the abdomen, may do more than cause discomfort.

Doctors can drain ascites to ease pain, improve mobility and make breathing easier, but the fluid may also help cancer cells survive and spread. It occurs in 90 per cent of people with advanced ovarian cancer.

According to the study, ascites acts as a shield, helping cancer cells evade ferroptosis, a form of cell death.

Ferroptosis is a kind of cellular rusting. It happens when iron inside a cell reacts with certain fats, causing the cell membrane to break apart.

Many metastatic cancer cells, meaning cells that float freely through the abdomen looking for new places to grow, are naturally vulnerable to this kind of damage.

“Doctors have mostly viewed ascites as a symptom rather than an active driver of disease,” said Jen-Tsan Chi, professor in the department of molecular genetics and microbiology and co-leader of the Cancer Biology Program at the Duke Cancer Institute.

“We’ve learned it gives cancer a survival advantage, which fills a major gap in understanding how ovarian cancer spreads.”

Scientists bathed cancer cell lines and patient-derived tumour cells in ascites collected from patients and watched how they responded to ferroptosis triggers.

The fluid protected cancer cells by changing how they store fats and control iron levels, effectively blocking cell death.

The protection required only trace amounts, with as little as 2 per cent immersion shielding cancer cells from destruction.

“What surprised us was how selective this effect was,” said Yasaman Setayeshpour, first author and graduate student in molecular genetics and microbiology at Duke School of Medicine.

“Ascites didn’t protect the cancer cells from other well-known types of cell death, like apoptosis or necrosis, it only blocked ferroptosis.

“To figure out why, we broke ascites down into major parts, like lipids, proteins, and small molecules, and tested what happened when each was removed.

“When we took the lipids out, the protective effect disappeared. That told us lipids are the key reason ascites helps these cancer cells survive.”

But researchers found an unexpected helper in bezafibrate, an older cholesterol drug used to lower triglycerides by altering how the body processes fats.

The cholesterol drug restored sensitivity to ferroptosis, but only when ascites was present. On its own, the drug did not trigger cell death or slow tumour growth in mice.

The drug’s impact depended on the cancer’s surroundings, in this case the fat-rich fluid bathing the tumour. Researchers found that targeting this environment, using repurposed drugs like bezafibrate, could leave cancer cells more exposed to existing cancer treatments.

Chi said the finding could have implications beyond ovarian cancer. Other cancers, including colorectal and pancreatic cancers, can also spread within the abdominal cavity.

“This work shows how much the environment around a tumour matters,” Chi said.

“Biological fluids like ascites don’t just give cancer cells a place to move. They actively help drive how cancer spreads.”

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