Enlighten® is a qualitative in vitro diagnostic blood test that measures patterns of circulating amino acid biomarkers in human plasma and applies a machine-learning–based algorithm to identify profiles associated with an increased probability of underlying malignancy for up to ten solid tumours, including breast, colorectal, lung, and prostate cancers, each of which has established diagnostic pathways within UK clinical practice.

The test is intended for use in adults (18 years and older) who present with signs or symptoms suggestive or non-specific of cancer, or who are recognised by UK clinical guidelines as being at increased risk of malignancy. Enlighten® is designed to support clinical assessment by providing adjunctive information to inform decisions regarding further investigation.

Enlighten® does not diagnose or exclude cancer and must be interpreted in the context of other clinical findings. A result indicating an elevated probability of malignancy should be considered alongside standard clinical evaluation and may support referral for further diagnostic assessment in accordance with established clinical pathways.

A high unmet need

In England, over 2.9 million patients are referred annually on urgent suspected cancer pathways. This has more than doubled over the past decade, increasing from just over 900,000 in 2009/10 to nearly 3 million in 2022-23. Despite this scale, only 6-7% of urgent referrals result in a cancer diagnosis. Importantly, over half (56%) of cancers are detected through these pathways. This creates a system under significant pressure; high volume, low precision, but critical to cancer detection. The remainder of cancer diagnoses are still first diagnosed when a patient arrives at A&E with acute symptoms (~20%), routine screening programmes (such as bowel, breast, and cervical), and routine GP referrals i.e., patients who see a GP for symptoms that do not initially meet the "urgent" criteria.

There is a clear need to improve the precision and efficiency of cancer detection by identifying high-risk patients earlier, reducing unnecessary referrals while ensuring timely diagnosis for those most likely to have cancer.

Enlighten® addresses this need by providing a novel blood-based measure of malignancy risk to support more informed clinical assessment and referral decisions within existing pathways.

Under Clinical Evaluation

MODERNISED aims to lay the groundwork for a scalable multi-cancer early detection programme in the NHS.

Our long-term ambition is to enable stage-one cancer detection at scale, supporting the NHS Long Term Plan ambition that by 2028, 75% of cancers are diagnosed at an early stage (Stages 1 or 2).

MODERNISED is our two-year, NIHR (National Institute for Health and Care Research) and Office for Life Sciences (DHSC, DSIT) funded clinical study led by the Southampton Clinical Trials Unit and Proteotype Diagnostics Ltd.

The trial will enrol 1,350 volunteers across southern-England NHS hospitals to validate Enlighten®.

A high unmet need

Under Clinical Evaluation

Protocol Paper

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