Platform Expansion: Gastric Cancer Diagnostic Test Update

Posted: 25 September 2024

Transformative, predictive cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX: RHY) (“Rhythm” or the “Company”) is pleased to provide an update on its cancer diagnostics technology platform expansion program in gastric cancer. Rhythm has identified protein biomarker combinations that effectively differentiate between blood samples from cancer patients and those form healthy controls.

Gastric cancer has poor outcomes in the general population with an observed 5-year survival (2016-2020) of 38% compared to, as an example, 96% or 92% for prostate and breast cancer for the same period1. Currently, the gold standard method to detect gastric cancer is upper endoscopy in combination with tissue biopsy. This method has sensitivity and specificity values of 69% and 96%, respectively. However, it is an invasive, costly, and time-consuming methodology2. Consequently, gastric cancer is largely diagnosed as regional or distant disease in 56% of the cases compared to 25% and 32% for prostate and breast cancer (US Data for 20213) supporting the conclusion that earlier detection is a priority and bloodbased methods of detection being developed by the Company could be valuable clinical tools.

The geographical distribution of the disease differs from the other more common cancers with significantly higher prevalence in Asia with disease rates per population being up to 6X higher in some Asian geographies compared to the USA. Of the approximately 1 million new cases diagnosed globally each year, over 50% are diagnosed in Asia (China 360,000, Japan 127,000, Korea 30,000 and Vietnam 16,000)4.

A case/control study was completed to assess the feasibility of identifying combinations of blood protein biomarkers capable of discriminating between blood samples from patients with gastric cancer and those of healthy controls. Rhythm’s collaborators used experimental immunoassays to quantify 19 candidate blood-based protein biomarkers in sera from 100 gastric cancer patients and 100 healthy volunteers (cohort details summarised in the table below). Univariate and multivariate analysis identified promising combinations of 6, 7 and 8 protein biomarkers that can distinguish between patients with and without gastric cancer with sensitivities > 75% at a specificity of >90%.

These encouraging results warrant confirmation in a larger and more diverse population. To this end, the Company is currently preparing plans to develop this potential gastric cancer assay in conjunction with its multiplex assay development partner. Thereafter, the prototype assay will be clinically validated with an aim to produce a commercially scalable, proprietary blood test to detect gastric cancer early when it is most responsive to potentially curative treatments.

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