In a UK first, researchers in Manchester are successfully identifying patients in the early, curable stages of a common liver cancer using a new, innovative test.
The study team at Manchester University NHS Foundation Trust (MFT) and The University of Manchester (UoM) implemented the new technology across MFT hospitals in December 2023, which provides specialist liver care to the Greater Manchester region. The technology aims to improve early detection of hepatocellular carcinoma (HCC) – the most common cancer affecting the liver and the third most common cause of cancer death.
Developed by Roche Diagnostics, the pioneering test, known as Elecsys®GAAD, combines blood tests with gender and age, which can increase the detection rate of HCC at an early, curable stage. This is being used alongside routine surveillance tests to see how it can benefit patients, so they have the best chance of surviving this type of cancer.
One of the risks for developing HCC is a pre-existing liver disease and scarring of the liver, known as cirrhosis. Approximately 3,000 people are found to have HCC in the UK every year. Less than 1,000 are identified at a stage when they can have curative treatment, leaving over 2,000 people per year with a cancer that cannot be cured.
More than 600 patients with cirrhosis have been tested using Elecsys®GAAD within clinics at Manchester Royal Infirmary, Wythenshawe Hospital and North Manchester General Hospital, all part of MFT, and four patients have been detected with early-stage liver cancer at a treatable stage, which would not have been found without the new technology.
**Gerry’s story**
Father of three, Gerry, 67 was diagnosed with hemochromatosis approximately 15 years ago, a hereditary condition where the body stores too much iron, which has led to scarring on his liver, cirrhosis.
Whilst attending his routine screening appointment at Wythenshawe Hospital, Gerry joined the research trial using the Elecsys®GAAD technology, which detected the early stages of liver cancer.
Following a number of CT scans at Manchester Royal Infirmary, it was confirmed that there is a small tumour on the upper part of his liver, which he has now had removed and remains cancer free.
**Gerry said:** “I was shocked to find out that I had liver cancer, but also relieved that it had been found early and it hadn’t spread any further. I didn’t have any symptoms that would make me think that there was anything wrong, so I am grateful that the cancer has been caught early, where a number of treatment options are available to me.
“It isn’t until you’re in this position, that you truly realise how cancer can affect anyone, and detecting it early can save your life. I would encourage others to take part in this research trial, if given the opportunity, as this new technology will save lives. I am grateful to be in a position where curative treatment is available and I am now cancer free.”
**How the technology works**
In early, curable stages, HCC can have no symptoms and so it is recommended that everyone with known cirrhosis is tested every six months which involves an ultrasound scan and a blood test (alpha fetoprotein – AFP) to screen for primary liver cancer – HCC.
The new test is an algorithm used in addition to the current standard of care, which uses the AFP information alongside another blood test (Elecsys®PIVKA-II), age and gender to calculate a risk score. Data suggests that this test increases the likelihood of detecting liver cancer at an earlier stage where curative treatments are far more likely.
**Principal Investigator for the study, Dr Varinder Athwal, Consultant Hepatologist at MFT and Honorary Senior Lecturer at the University of Manchester, said:** “Manchester has some of the highest rates of liver disease and liver cancer in the UK and far too many people are diagnosed when curative treatment is not possible.
“This innovation is a non-invasive test that easily fits into our current pathway. Early results from the project are very promising and show we are able to detect more cases of HCC at earlier, treatable stages which would have been missed by standard routine care – so it truly has the potential to save lives.
“Using this new test and with additional improvements to the surveillance pathway, we believe more than 1,000 people per year could be additionally detected at an earlier stage when their cancer is potentially curable. This number could be increased if more people are offered the test and stay in surveillance, which is something we are addressing in this project.”
**Vic’s story**
Vic joined the research trial at MFT and was detected in the early, curable stages of liver cancer and despite not being fit enough for common therapies to cure his cancer, Vic has since received a treatment called transarterial chemoembolisation (TACE) which cuts off the tumour’s blood supply with little or no effect to liver functioning.
Detecting his cancer early through Elecsys®GAAD means that it has prevented the spread of his cancer and there is currently no sign of his cancer on repeat scans.
**He said:** “When I agreed to join the trial, I had been being monitored routinely because of the presence of liver disease but the last thing that I thought I would ever develop was cancer. I had been stable for some years and had not experienced any new symptoms to suggest anything had changed.
“The GAAD test changed all that. The results were high and detected that I had a primary liver cancer which turned out to be a Stage 2 liver cancer. I had no symptoms. I was referred immediately for expert treatment.
“Because the GAAD test detected the cancer early I have been able to access one of several treatment options quickly, before the cancer had the chance to spread outside the liver. Early diagnosis and treatment has meant that I can also benefit from the care and support of an amazing multidisciplinary team.
“It has also meant that I have been given time to involve my family, especially my children, to navigate this journey together. Without the GAAD test, the diagnosis of cancer may have come too late for all of us.”
Through the study, researchers aim to find out if the Elecsys®GAAD test reduces unnecessary further scans and if it improves earlier detection of HCC. They will also investigate if a six-monthly ultrasound adds any further benefit to Elecsys®GAAD to detect HCC – or if Elecsys®GAAD could be used on its own, which would provide a considerable cost saving to the NHS and a significant improvement to current standard of care.
**Director of Access and Innovation at Roche Diagnostics UK and Ireland, Chris Hudson said:** “Roche Diagnostics is committed to early disease diagnosis and to ensuring our innovations reach the people who need them. Working with the team in Manchester, we are taking the learnings from this hugely successful trial to help other NHS Trusts implement the Elecsys®GAAD digital diagnostic solution and enable more patients with liver cancer to access timely diagnostics and potentially curative treatments.”
**Dr Katherine Boylan, Director of Innovation at MFT said:** “As one of the largest NHS trusts in the country, MFT is uniquely placed to test the innovation, which brings together the knowledge and expertise of academic, medical and industry partners – strengthening our position as a leader in research and innovation in the UK. We are proud to partner with Roche Diagnostics to address this unmet clinical need for the benefit of our patients, which has the potential to revolutionise early cancer diagnosis for HCC.”
Elecsys®GAAD was fast-tracked into the NHS at MFT, following £1million funding from NHS England, to test the accuracy and benefits of technology over a two-year period.
Project Managers at NHS England visited MFT alongside Roche Diagnostics, to see the progress of the project and how we are utilising the test alongside current pathways.
**Dr Michael Gregory, Regional Medical Director for NHS England – North West, said**: “This is a great example of how the NHS can transform health outcomes and save lives through the use of cutting-edge technology and a greater focus on prevention.
“The stories of the patients who have already benefitted from this new test highlight why it is so important that we diagnose and treat cancers at the earliest possible opportunity and I’m excited to see how it could be made more widely available in the future.
“In the meantime, I would continue to encourage people with potential signs of cancer to come forward and speak to their general practice as soon as possible.”
The study is running until April 2025, recruiting more than 600 patients to the research project. Findings from the implementation at MFT will be used to co-develop a plan for the national roll out within the NHS.
This work is supported by Imperial College London who are observing the economic impact of the new technology on the NHS, and Unity Insights who are carrying out an independent evaluation of the findings across the project.