Australian diagnostics company to launch “world’s first” risk test for breast and ovarian cancer

The Australian diagnostics company Genetic Technologies Limited is preparing to launch “world’s first” risk assessment test for breast and ovarian cancer.

The test evaluates women’s risk of developing breast and ovarian cancer either from a hereditary genetic mutation or from the far more common familial or sporadic cancer.

The company says this approach “appends” the detection of the 13 major actionable breast and ovarian cancer susceptibility genes to its cancer test platform, advancing the goal of providing population-based genetic screening.

Globally, there are more than 2.26 million cases of breast cancer and 313,000 cases of ovarian cancer diagnosed annually.

In the US there are 297,790 new cases of invasive breast cancer that are diagnosed annually and 19,880 women diagnosed with ovarian cancer.

Currently women are under-screened and underdiagnosed for risk of hereditary breast and ovarian cancer syndrome (HBOC) based on their clinical criteria.

There is considerable evidence that these criteria do not capture all women who are HBOC carriers.

One recent general population screen among more than 6,000 women found that of 38 HBOC carriers identified nearly half would not have qualified for HBOC testing based on clinical criteria and their elevated risk of cancer would not have been identified.

The risk assessment, developed by Genetic Technologies (GTG), is performed from a single saliva sample and aims to inform women of their risk profile and give them the opportunity to take proactive actions to increase screening and lessen their risk of developing the two types of cancer.

“GTG believes this comprehensive risk test for breast and ovarian cancer is one of our most important and significant contributions to the advancement of population-based genetic testing,” said CEO, Simon Morriss.

“We are moving beyond rare cancer-susceptibility genetics. We can look for the needle in the haystack, but we are also able to look at the haystack itself.

“Our non-invasive risk assessment test will address cancer risk at a population health level.”

The company says the test will be clinically validated and have appropriate regulatory approval and will be showcased at the BRCA 2023 Symposium in Montreal in May.

Teal Health secures US$8.8m to tackle cervical cancer

The US healthcare company Teal Health has raised US$8.8m in seed funding to build a platform for tackling cervical cancer.

The company’s at-home cervical cancer screening includes a novel self-collection device that aims to make it simple for women to collect cervical cancer screening samples from home.

According to the developers, the platform is designed to increase women’s confidence and adherence to screen for primary HPV and Pap cytology triage and enable conversation and engagement with medical professionals.

If caught early, 93 per cent of cervical cancers are preventable. Following the start of the COVID-19 pandemic, cervical cancer screening in the US dropped by 94 per cent and remained 35 per cent below pre-pandemic levels even after stay-at-home restrictions were lifted.

New research has shown that late-stage cervical cancers are on the rise in American women.

In contrast to more than 90 per cent of cervical cancers being preventable when caught early, a late-stage diagnosis has an approximate five-year survival rate of only 18 per cent.

“The current cervical cancer screening, a critical piece of women’s health, is notoriously unpleasant and uses a speculum. Despite medical and technological advancements, including adding the primary HPV test to the screening guidelines, the screening experience hasn’t been updated since the 1940s,” said Kara Egan, Teal Health CEO.

“At Teal we are working to increase access to this important screening by coupling at-home self-collection with a health-tech platform that ensures women are encouraged, supported, and understood in the process.”

The US$8.8m seed round was supported by investors, including Emerson Collective, Serena Ventures, Metrodora Ventures, and Felicis Ventures.

The funding will allow the company to expedite product development, clinical testing, and FDA approval, facilitating access to the 88 million women within recommended screening age and reversing the rise of late-stage cervical cancer.

Serena Williams, managing partner at Serena Ventures, said: “For far too long women have been disenfranchised by their current healthcare experiences, with women of underrepresented communities feeling an increased strain on their access and options surrounding healthcare.

“We’re excited to partner with Teal to increase equity and access to this life-saving screening by removing the barriers such as awareness, time, and fear while also empowering women to reconnect and take control of their health.”

Chelsea Clinton, managing partner at Metrodora Ventures, said: “Solving massive and critical health issues, including adherence to a national cancer screening, requires innovative solutions with expertise across the entire healthcare landscape.

“Teal understands this complexity and is well positioned to take on the challenge through its dynamic team and strategic partner base, which spans health policy, cancer research, technology, consumer brands, and more.”

Teal’s clinical study is underway and early data found that 89 per cent of women said that if at-home collection were available, they would get screened on time.

The findings have also shown that self-collection option is preferred by 91 per cent of study participants when compared to a clinical collection with a speculum.

UK government to invest £10m in new breast cancer screening units

The UK government has announced a £10m investment to develop 29 new breast cancer screening units.

The units will be directed to areas where they are most needed to increase capacity and speed up diagnosis and treatment.

The announcement follows concerns voiced by the charity Breast Cancer Now over a decline in breast cancer early-stage diagnosis as a result of the pandemic.

The data has shown a dip in the rate of early, stage one and two, breast cancer diagnosis – a sharp contrast to the years leading up to the pandemic when early diagnosis rates were rising.

The government’s latest investment is hoped to reverse the trend, allowing more women to be screened earlier and access care closer to home.

“Last year 100,000 people were diagnosed with cancer at stages one and two. This is the highest proportion on record but we want to do better still,” said Minister of State for Health, Helen Whately.

“These breast cancer screening units will mean more people can get checked for cancer, closer to home.

“Most people will get the reassurance of an all-clear but for those who are diagnosed, catching their cancer early is the best thing we can do.”

As part of the investment, the government will provide 16 new mobile breast screening units, 13 static units, 58 live remote access upgrades for existing units and 10 software upgrades in areas with existing units to carry out ultrasounds and X-rays.

The funding is now in place for NHS trusts to spend within the 2022 to 2023 financial year and the timing for delivery of units will be individual to each trust.

Steve Russell, NHS national director for screening and vaccinations, said: “Screening is vital in detecting breast cancer early and getting better outcomes for patients, and this further investment is great news for improving access to breast screening services for women across England.

“This funding will help increase screening rates among women from communities and regions where uptake is lowest by improving facilities in both fixed and mobile locations, making it easier for more women to get checked, and we encourage anyone invited for a screening to take up their appointment without delay and help us catch cancers earlier when they are easier to treat.”

Ciarán Norris, head of campaigns and public affairs at Macmillan Cancer Support, said: “We welcome any intervention that helps to speed up diagnosis and improve access to cancer screening services, particularly in areas where they are most needed, as we know the earlier someone is diagnosed the better their outcome is likely to be.

“Alongside this, we also look forward to working with the government on steps to grow and sustain the cancer workforce, to ensure our cancer services can provide timely treatment and care for everyone living with cancer, both now and in the future.”

Breast screening is one of the best ways to spot a cancer that is too small to feel or see. Each year more than two million women have breast cancer screening in the UK through the NHS Breast Screening Programme.

“Revolutionary” surgical knife could detect womb cancer within seconds, say experts

A surgical knife that “smells tumours” can diagnose womb cancer within seconds, researchers at Imperial College London have revealed.

Around 9,400 women are diagnosed with endometrial cancer, also known as uterine or womb cancer, in the UK each year. This makes it the country’s fourth most common cancer in women and the sixth most common globally.

However, only about 10 per cent of those with suspected symptoms who undergo a biopsy are found to have it.

Researchers have now found that the iKnife, a device that is already used to treat breast and brain cancers, can detect the presence of endometrial cancer with nearly 90 per cent accuracy.

Writing in the journal Cancers, the research team said: “The iKnife reliably diagnosed endometrial cancer in seconds, with a diagnostic accuracy of 89 per cent, minimising the current delays for women whilst awaiting a histopathological diagnosis. The findings presented in this study can pave the way for new diagnostic pathways.”

According to Imperial College London, the iKnife is based on electrosurgery, a technique invented in the 1920s often used in surgery to control bleeding and to rapidly dissect soft tissue in surgery.

Electrosurgical knives use an electrical current to heat tissue, cutting through it while minimising blood loss. In doing so, they vaporise the tissue, creating smoke that is normally sucked away by extraction systems.

The iKnife’s inventor, Dr Zoltan Takats of Imperial College London, connected an electrosurgical knife to a mass spectrometer, an analytical instrument used to identify chemicals in a sample.

The device can tell the difference between cancerous and healthy tissue by analysing the smoke produced when tissue is vaporised.

The experts said its effectiveness was proved using biopsy tissue samples from 150 women with suspected womb cancer, and the results compared with current diagnosis methods.

Athena Lamnisos, chief executive of the Eve Appeal cancer charity which funded the research, told the Guardian: “Waiting for test results is stressful – especially if that test is to find out whether or not you have cancer. When you hear that the ‘c’ word is even a possibility, the days can’t pass quickly enough until a clinician gives you the all clear.

“Womb cancer has one ‘red flag’ symptom of postmenopausal bleeding that should always get checked out on a two-week referral from your GP. To wait a further two weeks for the results can be really hard for patients.

“There are many reasons for abnormal vaginal bleeding after the menopause – womb cancer is just one of them – the ability to provide a diagnostic test that rules cancer in or out immediately, and with accuracy, could make such a positive difference.

“This Eve-supported research has the potential to create a step change in faster diagnosis, and for the 90 per cent of women with postmenopausal bleeding that isn’t cancer, a really effective way to put their minds at ease. We know how important this is for patients.”

Prof Sadaf Ghaem-Maghami, who led the research, told the newspaper the iKnife has the potential to completely revolutionise the way healthcare professionals manage people seen in the rapid-access clinics with significant abnormal vaginal bleeding who have been referred for potential diagnosis of endometrial cancer.

“With its high diagnostic accuracy of 89 per cent and positive predictive value of 94 per cent, one could immediately reassure the person of the very low likelihood of having cancer if the iKnife result is negative and expedite further tests and scans and treatment for people whose biopsies indicate presence of cancer.

“This could happen whilst awaiting confirmation from standard pathology, which can take up to two weeks,” he added.