Did the Multi-Cancer Blood Test Fail to Meet Key NHS Trial Goals?

The Galleri blood test, designed to detect multiple types of cancer through a simple blood draw, has not met its key objective in a significant NHS trial involving 142,000 patients. While there are indications that it may help detect aggressive cancers earlier, experts caution that its efficacy in saving lives remains unproven, and any benefits are currently speculative.

Last updated: 09 October 2023 (BST)

What’s happening now

In a recent announcement, Grail, the US pharmaceutical company behind the Galleri blood test, revealed that the test did not achieve its primary endpoint in the NHS trial aimed at reducing late-stage cancer diagnoses. Despite this setback, Grail noted a promising trend indicating a reduction in stage four cancers, suggesting that some of the most aggressive forms of the disease might be detected earlier. However, the NHS has stated that it will evaluate the full results carefully before making any decisions about the test's future use.

Key takeaways

• The Galleri blood test has not met its primary objective in a large NHS trial.
• Some signs indicate a potential reduction in stage four cancers, which are often the most lethal.
• Experts urge caution until more comprehensive mortality data is available.

Timeline: how we got here

The Galleri blood test trial commenced as part of a significant initiative by NHS England to explore innovative cancer detection methods. Key dates include:

• September 2020: NHS announces the Galleri trial, aimed at early cancer detection.
• October 2023: Grail announces the trial results, stating the primary endpoint was not met.
• Upcoming: Full data presentation at the American Society of Clinical Oncology meeting later this year.

What’s new vs what’s known

New today/this week

Grail has reported that while the primary objective of the Galleri blood test trial was not achieved, there is a notable reduction in stage four cancers by approximately 20%. This finding has sparked discussions among researchers regarding the implications for early cancer detection.

What was already established

Prior to this announcement, the Galleri test was seen as a revolutionary approach to cancer screening. It is designed to detect up to 50 types of cancer by identifying DNA fragments in the bloodstream. The expectation was that early detection would lead to better treatment outcomes.

Impact for the UK

Consumers and households

The failure of the Galleri test to meet its primary goal raises concerns for patients who may have relied on the test for early detection. Currently, the NHS continues to explore other screening methods and technologies to enhance cancer detection and treatment.

Businesses and jobs

The outcome of this trial may impact investment and research within the pharmaceutical sector in the UK. Grail's share price fell significantly following the announcement, which could affect its funding and future research initiatives.

Policy and regulation

The NHS is assessing the full results of the trial to determine how blood tests like Galleri might be integrated into future cancer screening protocols. This could lead to potential policy changes regarding cancer detection in the UK healthcare system.

Numbers that matter

• 20%: Reduction in stage four cancers observed during the trial.
• 142,000: Number of patients involved in the NHS trial.
• 50: Types of cancer the Galleri test aims to detect.

Definitions and jargon buster

• Galleri test: A blood test designed to detect multiple types of cancer by identifying DNA fragments from tumours in the bloodstream.
• Stage three cancer: Cancer that has begun to spread locally but is potentially still treatable.
• Stage four cancer: Cancer that has spread to distant organs, making it more challenging to treat.

How to think about the next steps

Near term (0–4 weeks)

As the NHS begins to analyse the trial's data, stakeholders will be watching closely for any preliminary insights that might emerge. The focus will likely be on understanding the implications of the stage four cancer reduction.

Medium term (1–6 months)

In the coming months, the NHS is expected to issue further guidance regarding the integration of blood tests like Galleri in routine cancer screenings, dependent on the full trial results.

Signals to watch

• Release of the full trial data at the American Society of Clinical Oncology meeting.
• Further statements from NHS England regarding the future use of blood tests in cancer detection.
• Market responses concerning Grail and similar companies in the sector.

Practical guidance

Do

• Stay informed about updates from the NHS regarding cancer screening advancements.
• Consult healthcare professionals about personal cancer screening options that are currently available.

Don’t

• Rely solely on the Galleri test for cancer detection until more comprehensive data is available.
• Ignore potential symptoms or risk factors that warrant immediate medical consultation.

Checklist

• Check with your GP about current cancer screening recommendations.
• Monitor news for updates on the Galleri test and other cancer detection technologies.
• Consider discussing personal cancer risk factors with a healthcare provider.

Risks, caveats, and uncertainties

While there are promising signs of a reduction in stage four cancers, it is crucial to acknowledge that the trial did not meet its primary endpoint. Therefore, any claims regarding the effectiveness of the Galleri test must be viewed with caution. Issues such as false positives and the potential for unnecessary medical procedures highlight the need for further data to substantiate claims of population benefit from multi-cancer early detection.

Bottom line

The recent findings from the Galleri blood test trial present both challenges and opportunities in cancer detection. While the reduction in stage four cancers is encouraging, the failure to meet the primary endpoint necessitates careful scrutiny of the data. As the NHS evaluates the results, it remains essential for patients to engage in proactive discussions about their cancer screening options.

FAQs

What is the Galleri blood test?

The Galleri blood test is designed to detect multiple types of cancer by identifying DNA fragments from tumours in the bloodstream, aiming to catch cancers early before symptoms appear.

What were the results of the NHS trial for the Galleri test?

The trial did not meet its primary endpoint, but there was a noted reduction in stage four cancers, suggesting some potential for early detection of aggressive cancers.

What does this mean for cancer screening in the UK?

The NHS will review the trial results carefully to assess how tests like Galleri could be used in future cancer screening protocols, prioritising patient safety and efficacy.