An innovative blood test that may spot more than 50 types of cancer will be piloted by the NHS in a world-leading programme was announced by NHS chief executive Sir Simon Stevens.

illuminaThe Galleri blood test, developed by GRAIL, can detect early stage cancers through a simple blood test, and will be piloted with 165,000 patients in a world-first deal struck by NHS England. Research on patients with signs of cancer has already found that the test, which checks for molecular changes, can identify many types that are difficult to diagnose early, such as head and neck, ovarian, pancreatic, oesophageal and some blood cancers.

If the NHS programme shows the test also works as expected for people without symptoms it will be rolled out to become routinely available. The test could help meet the NHS Long Term Plan goal of increasing the proportion of cancers caught early, which can be the key to reducing cancer mortality. Patients whose condition is diagnosed at ‘stage one’ typically have between five and 10 times the chance of surviving compared with those found at ‘stage four’.

NHS Chief Executive Sir Simon Stevens said: “While the good news is that cancer survival is now at a record high, over a thousand people every day are newly diagnosed with cancer. Early detection – particularly for hard-to-treat conditions like ovarian and pancreatic cancer – has the potential to save many lives. This promising blood test could therefore be a game-changer in cancer care, helping thousands more people to get successful treatment. This trial again confirms that the NHS is at the forefront of cutting edge treatments and technology.”

In England, around half of cancers are currently diagnosed at stage one or two but the NHS Long Term Plan is aiming to increase that to three quarters by 2028. The GRAIL pilot, which is due to start in mid-2021, will involve 165,000 people. That will include 140,000 participants aged 50 to 79 who have no symptoms but will have annual blood tests for three years. People will be identified through NHS records and approached to take part. Anyone with a positive test will be referred for investigation in the NHS. Another 25,000 people with possible cancer symptoms will also be offered testing to speed up their diagnosis after being referred to hospital in the normal way.

Results of these studies would be expected by 2023, and if outcomes are positive, then they would be expanded to involve around one million participants across 2024 and 2025.

Health and Social Care Secretary, Matt Hancock said: “We are building a world leading diagnostics industry in the UK – not just for coronavirus but for other diseases too. This exciting and ground-breaking new blood test from GRAIL will give us another tool to give more people the very best chance of survival, demonstrating how the UK continues to lead the way in using the latest innovative treatments to help patients. “Many of us know a loved one who has battled against cancer and have seen first-hand the impact of this deadly disease.”

Professor Peter Johnson, National Clinical Director for Cancer at NHS England and improvement said: “The NHS has set itself an ambitious target, to find three-quarters of cancers at an early stage, when they have the highest chance of cure. Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out, as we test it in clinics across the NHS.”

Dr Mangesh Thorat, Deputy Director (Clinical) of the Cancer Prevention Trials Unit at King’s College London said: ““The Galleri test performs a Targeted methylation analysis of cell-free DNA (cfDNA) in blood (www.annalsofoncology.org/article/S0923-7534(20)36058-0/fulltext) and appears to have a reasonably good sensitivity for a select group of 12 cancers with an acceptably low false-positivity rate in a large case-control study (first type of study in clinical development pathway of a test). The test also appears to have good sensitivity in certain high mortality cancers e.g. Pancreatic and Oesophageal cancers where we do not yet have a good early detection test; this is a major strength. Another strength is that the test can also pinpoint to the location of cancer in a very high proportion of cancers, thereby guiding focussed next set of investigations. With these performance characteristics, the obvious next step would be to evaluate it in a larger cohort study representative of target population. “The NHS pilot appears to be this next research study and one would expect that invitees are appropriately informed that they are being invited to participate in this research study. It is likely that for every testing round in this pilot population, there will be about 1000 false-positive results and the test may not be able to pinpoint the location of cancer in 3-4% of those with true positive result, necessitating a range of imaging and other investigations in these participants. Invitees will need to consider the potential harms associated with such investigations and anxiety caused by a positive test result.”

Sir Harpal Kumar, President of GRAIL Europe, said: “The Long Term Plan for cancer is one I’ve been immensely supportive of since it was published, and I applaud the NHS and the government for setting out these ambitious goals and road map to diagnosing cancers earlier. “Galleri, a simple blood test that’s capable of detecting more than 50 cancers, is a ground-breaking and potentially life-saving advance that could have a tremendous human and economic benefit. “Grail is thrilled to partner with the NHS and UK government to support the NHS Long Term Plan for earlier cancer diagnosis, and we are eager to bring our technology to patients in the UK as quickly as we can. I’m delighted we have the opportunity to work together to see if we can save many thousands more lives from cancer in the UK every year.”

Lord David Prior, Chair of NHS England said:  “Every year nearly 200,000 people in the UK die from cancer. Many of these people are diagnosed too late for treatment to be effective. This collaboration between the NHS and GRAIL offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer.”

Grail anticipates Galleri to become commercially available in 2021 as a laboratory developed test (LDT). They then plan to submit a premarket approval application (PMA) of a subsequent version of Galleri in as early as 2023.

Illumina Inc. is looking to acquire Grail Inc. for $7.1 billion, the Wall Street Journal reported on Monday. The company is already a partial owner of Grail, a gene-sequencing company, and is now planning to buy the rest of the stake with $3.1 billion in cash and $4 billion in shares.

The acquisition would give Illumina access to Grail's blood test for early cancer detection, commonly known as liquid biopsy, sources close to the talks said.

 

Sources:

england.nhs.uk - annalsofoncology.org - sciencemediacentre.org - nanalyze.com - teletrader.com