Multi-Cancer Early Detection Test Measures Host Response to Tumor Development

Approximately 70% of cancer fatalities occur from cancers that do not have available screening methods. Many cancer diagnostic approaches depend on signals released by tumors, such as circulating tumor DNA, which is frequently only detectable once the cancer has advanced. Now, a novel test offers a revolutionary approach to detecting early-stage cancers by focusing instead on the body's response to tumor development.

Proteotype Diagnostics (Cambridge, UK) has developed the Enlighten Multi-Cancer Early Detection test, which evaluates the host's response to tumor development by monitoring changes in protein levels that arise even during the earliest cancer stages. The test utilizes an economical, fluorescence-kit-based microplate reader assay to assess the host's response to tumor development, which is most pronounced in early-stage cancers. Proteotype’s biorthogonal chemistry allows for direct measurement of the host response from crude patient plasma, thereby removing the need for complex sample preparation. This allows Enlighten to be provided at a lower cost compared to existing tests while maintaining high sensitivity and specificity, particularly for early-stage diseases. Proteotype’s unique technology allows whole blood samples to be stored at room temperature in standard, inexpensive EDTA collection tubes for up to 48 hours before being processed into plasma. This capability facilitates sample collection in various settings (such as pharmacies and mobile vans), reducing the burden on primary healthcare providers for population-level testing.

Currently, Proteotype is conducting clinical validation of Enlighten for breast, colorectal, prostate, pancreatic, lung, melanoma, esophageal, ovarian, bladder, and renal cancers. Initial results have been encouraging, with Proteotype reporting an 86% detection rate across multiple cancer types, a 0% false-positive rate, and strong signals for early-stage cancers. The next step is to validate the test in a larger patient cohort, allowing for a statistically powered performance evaluation. Enlighten will be tested in a real-world environment, with a particular emphasis on reaching higher-risk, underserved populations. The new clinical study aims to enroll 1,350 participants, focusing on cancers with high mortality rates in socio-economically disadvantaged areas, such as colorectal, lung, and pancreatic cancers. In the near future, the company plans to expand clinical validation to additional tumor types, including stomach, liver, and thyroid cancers. The goal is to transform cancer detection practices, improve population health outcomes, and reduce health disparities.

"When cancer is discovered earlier, patients have more treatment options and better outcomes. Enlighten is designed to disrupt, detecting cancer as early as the immune system, whilst remaining simple enough yet robust enough to fit existing care pathways and NHS needs," said Dr. Emma Yates, co-founder and Chief Scientific Officer at Proteotype Diagnostics.

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Proteotype Diagnostics