The Galleri® Multi-Cancer Early Detection Test in Leicester

Offered by The Health Suite in partnership with Preologi, who are the first provider in the UK to offer the Galleri®Test.

Why it matters: the screening gap patients face today

In the UK, only four cancers have a recommended national screening test — breast, cervical, bowel and lung. Together, these programmes detect only a small fraction of all cancers, which means most are still found only once symptoms appear, often at a later and harder-to-treat stage.

• 4 cancers have a recommended UK screening test today (breast, cervical, bowel, lung).
• 5–6% of all cancers are currently detected through those screening programmes.
• ~45% of UK cancers are diagnosed at stage 3 or 4, when treatment is far less effective.
• Below 20% five-year survival for many late-stage cancers, versus over 90% for many cancers caught at stage 1.

What it is: one blood draw, a signal common to over 50 cancers

Galleri® is a multi-cancer early detection (MCED) test developed by GRAIL. Rather than looking for one cancer at a time, it analyses cell-free DNA (cfDNA) shed into the bloodstream — including cancer cells — and reads its methylation patterns. There are patterns that are unique to cancer cells; when detected, they can predict where in the body the cancer is from.

Its particular value is that most of these cancers have no recommended screening programme in the UK at all. Galleri® is designed to complement — not replace — established programmes such as breast, cervical and bowel screening.

How the test works — the science

1. Blood Sample — a single sample is taken at the clinic. No fasting or special preparation.
2. Extract and sequence the DNA fragments from the blood to “read” the methylation patterns.
3. Determine if DNA fragments may have originated from cancerous cells.
4. If cancerous DNA fragments are identified, use pattern recognition to predict the organ associated with the DNA fragments.
5. Signal origin — where present, the likely tissue of origin is predicted.

Galleri® is a screening aid, not a diagnostic test. A positive result needs diagnostic confirmation; a negative result does not rule out cancer.

What the studies show

Galleri®is supported by a large evidence base for a screening test: the PATHFINDER and PATHFINDER 2 studies (around 42,500 participants) and the NHS-Galleri® trial — the world’s largest MCED study, with more than 140,000 participants.

• 99.6% specificity — fewer than 1 in 200 people without cancer will receive a false-positive result.
• 40.4% overall sensitivity across all cancers (73.7% for the 12 deadliest cancers).
• ~93% accuracy in predicting the cancer’s tissue of origin.
• 61.6% positive predictive value — around 6 in 10 positive results are confirmed as cancer.

More aggressive cancers tend to release more cell-free DNA into the bloodstream at early stages. Making them more likely to be detected by Galleri®.

Sensitivity varies considerably by cancer type; it is highest for the higher-mortality cancers that shed more DNA earlier. No MCED test has yet published evidence that screening reduces cancer mortality.

The Galleri® test screens for a signal across 50+ cancers

These include many cancers with no existing NHS screening programme. A selection of the cancer types:

• Chest & Airway: lung, head & neck, oesophageal.
• Digestive: colon & rectum, pancreatic, stomach, liver, bile duct, gallbladder, anus.
• Women’s health: breast, ovarian, cervix, uterus.
• Blood & other: lymphoma, leukaemia, plasma cell myeloma, melanoma, bladder & upper urinary tract — and more than 50 in total.

Who it’s for

Galleri® is intended as an addition to standard screening for adults at higher risk of cancer — typically those aged 50 and over.

• Adults aged 50 and over, or aged 22 and over with an elevated personal or family risk.
• Individuals with a personal history of cancer, smokers or former smokers
• Anyone wishing to take a proactive approach with their health.

Important information — intended use & limitations

• Intended for adults with an elevated risk of cancer, such as those aged 50 or older. It is not recommended during pregnancy, for those aged 21 or under, or for anyone in active cancer treatment.
• It does not detect all cancers and must be used in addition to — not instead of — routine screening.
• A positive result requires diagnostic confirmation through further clinical investigation; it is not a diagnosis.
• A negative result does not rule out cancer or replace ongoing screening. Continue to act on any new or persistent symptoms.