12-13 - Healthcare

Researchers have developed a blood test able detect more than 50 types of cancer that is accurate enough to be used nationally as a multi-cancer screening test in those at higher risk of the disease, including those aged over 50 with no symptoms.

The test involves taking a sample of blood from each patient and analysing it for DNA, known as cell-free DNA (cfDNA), shed by tumours (and other cells) into the blood. Genomic sequencing is used to detect chemical changes to the DNA (methylation) that control gene expression, and a classifier developed with machine learning (artificial intelligence; AI) uses these results to detect abnormal methylation patterns that indicate the presence of cancer.

In addition, the AI classifier can also predict the location of the cancer in the body, with results available within ten business days from the time the sample reaches the lab.

The third and final sub-study of the Circulating Cell-free Genome Atlas (CCGA) study, published in the Annals of Oncology, investigated the performance of the test in 2,823 people already diagnosed with cancer and 1,254 people without cancer.

The findings show that the test was able to detect cancer signals from more than 50 different types of cancer across all four cancer stages (I, II, III, IV), correctly identifying when cancer was present in 51.5% of cases. The test’s specificity was 99.5%, thus showing that it wrongly detected cancer in just 0.5% of cases.

According to the data, sensitivity of the test was 67.6% overall across stages I-III in 12 pre-specified cancers that account for two-thirds of cancer deaths in the US annually (anal, bladder, bowel, oesophageal, stomach, head and neck, liver and bile duct, lung, ovarian and pancreatic cancers, lymphoma and cancers of white blood cells such as multiple myeloma), and 40.7% overall in more than 50 cancers.

For all cancers, detection improved with each later cancer stage with a sensitivity rate of 16.8% at the early stage I, 40.4% at stage II, 77% at stage III and 90.1% at stage IV.

Research also showed that sensitivity varied by type of cancer; in solid tumours that do not have any screening options – such as oesophageal, liver and pancreatic cancers – overall sensitivity of the test was twice that for solid tumours that do have screening options, such as breast, bowel, cervical and prostate cancers: 65.6% compared to 33.7%. Overall sensitivity in cancers of the blood, such as lymphoma and myeloma, was 55.1%.

The test also correctly identified the tissue in which the cancer was located in the body in 88.7% of cases, the researchers said.

“These data add to a growing body of literature that supports the use of next-generation sequencing for the detection of cell-free DNA in blood samples as a tool for earlier detection of common cancers that account for a significant number of deaths and other health problems worldwide,” said first author of the paper, Dr Eric Klein, chairman of the Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, US.

NHS England has announced a £40 million cash injection for mental health services for children and young people, to address increasing demand and the COVID-19 impact on mental health.

The funding boost, which is in addition to £79 million already made available by the government to support children and young people’s mental health in the community, will be used to address the increasing demand for the treatment of eating disorders in this age group and extra beds at units which provide care for young people with complex needs, and ensuring there are additional facilities for children under the age of 13 years.

It will also be used for a number of other schemes, including supporting services to prevent the need for admission and training staff working with children with mental health issues, to ensure they have the skills to manage such conditions even if they are not specialist mental health staff.

More funding will also go toward establishing an intensive community support role, in a bid to prevent children from being admitted to hospitals and facilitating earlier discharge where possible.

“This additional funding is in recognition of the rising demand and our continued commitment to provide the best care as early as possible and to do as much to prevent children and young people needing hospital treatment as we do to ensure that when they are in hospital they receive the right treatment before being supported back at home,” said Claire Murdoch, national mental health director, NHS England

The UK government has announced a hefty £36 billion funding boost for artificial intelligence (AI) research technologies in a bid to help the NHS transform the quality of patient care.

The funding will go toward 38 winners of the second wave of the NHS AI Lab’s AI in Health and Care Award, which aims to accelerate the testing and evaluation of AI in the NHS so patients can benefit from faster and more personalised diagnosis and greater efficiency in screening services.

The winning projects, backed by NHSX and Accelerated Access Collaborative (AAC), include: an AI-guided tool to help doctors and nurses to diagnose heart attacks more accurately; an algorithm to fast-track the detection of lung cancer; an AI-powered mental health app to help tackle symptoms of anxiety and depression while also identifying people experiencing severe mental health difficulties; and new technology to help spot undiagnosed spinal fractures.

The AI award package also includes funding to support the research, development and testing of early phase, promising ideas which could be used in the NHS in the future.

Since the first round of the AI in Health and Care Award in September, where £50 million was given to 42 AI projects, over 17,000 stroke patients and over 25,000 patients with diabetes have benefited from the new technologies.

“Through our NHS AI Lab we’re now backing a new generation of ground-breaking but practical solutions to some of the biggest challenges in healthcare,” said NHS chief executive Simon Stevens. “Precision cancer diagnosis, accurate surgery, and new ways of offering mental health support are just a few of the promising real-world patient benefits. Because as the NHS comes through the pandemic, rather than a return to old ways, we’re supercharging a more innovative future.”

The AI in Health and Care Award is set to distribute £140 million over three years – the next round of applications will open in late June. It is managed by the AAC in partnership with NHSX and the National Institute for Health Research (NIHR).

Why is patient centricity important to O4 Research?
Patients are at the heart of everything we do here at O4 Research. Along with others working in this sphere, we are doing so to ultimately help patients now, and in the future, so it makes sense to build our study designs around the patient, their needs and practicalities. It is also a win-win, because at O4, we clearly see the benefits for every one of our stakeholders as our studies are better received, recruitment and retention rates rise, data output improves and study site engagement increases. In the end, at O4, we believe ‘patient centricity’ is not just an important element in delivering high quality, patient focused research, it’s a prerequisite.

How do you ensure that it remains a key focus across the organisation?
We don’t actually need to work too hard at this, as everyone in the O4 Research team can clearly see the benefits this mindset and philosophy brings, and this in turn maintains a strong motivation to keep building upon our successes to date. In short, our ongoing evolution as a company is driven by making sure we are continually listening and learning. When we elicit feedback from our patients, study teams and sponsors, we find better ways to do things, and through such innovation, we improve the patient experience as a whole. In addition, this allows us to provide comprehensive training and structure to our wider teams with the knowledge that this approach ultimately helps every stakeholder in the process.

What is your vision for the future relationship between patients and CROs?
We see a continued strengthening of the mutually beneficial relationship between the patient and CRO. Although the last year and a half of COVID-19 has been a challenging time for everyone to some degree or another, and it’s hard to make a case for anything positive coming from it, it has perhaps engendered a newfound understanding and appreciation of the value of clinical research amongst the wider public. The pandemic has also accelerated some pre-existing trends that were already emerging, and we at O4 are keen to build on these. One key element is our use of technology including eConsent and ePRO to make research more interactive and less burdensome for our patients. Another developing area is the use of patient focus groups and where possible, integration of ‘Standard of Care’ processes to study design in order to increase efficiency and cost effectiveness. We see these trends continuing to gain traction in the future with growing emphasis on initiatives like ‘Direct to Patients’ as the industry evolves towards a more collaborative and less prescriptive approach to research, all the while, ensuring the patient is firmly rooted at the centre of our thinking.

Blood test can detect more than 50 types of cancer

New funding for children’s mental health services

£36m funding boost for AI research tech

PharmaTimes talk to...Moneeb Saddiq, clinical project director at O4 Research about keeping patients in the centre