Owlstone Medical delivers breath biopsy test data

Preliminary data has shown excellent safety, while also demonstrating proof of mechanism

Owlstone Medical – a company developing breath biopsy tests for early disease detection – has announced emerging data on the development of a screening test for the early detection of lung cancer.

Research progress was duly presented at the EACR 2023 Congress – the yearly meeting of the European Association for Cancer Research.

The company’s phase 1 study demonstrated Owlstone’s efforts to establish D5-ethyl-ß-glucuronide as a non-invasive probe for early cancer detection.

Prior research had already established its ability to detect D5-ethanol cleaved from the probe through the action of extracellular ß-glucuronidase in human cancer xenografted mice.

Following this, Owlstone determined the presence of extracellular ß-glucuronidase in tissue samples from human lung cancers, along with the ability to reliably detect D5-ethanol in human breath samples through ‘breath biopsy’ after administration of the Exogenous Volatile Organic Compound (EVOC) probe.

Meanwhile, in-human studies are now underway with phase 1a safety assessment and phase 1b dose optimisation study almost complete.

Preliminary data has shown excellent safety, while also demonstrating proof of mechanism through the measurement of D5-Ethanol levels in breath samples among lung cancer patients.

Billy Boyle, co-founder and chief executive officer of Owlstone Medical, was optimistic about the progress of the tests: “Through the studies presented, we are now confident we have the evidence we need to proceed to phase 2 of the EVOLUTION study.”

He added: “This new multi-site international trial will recruit up to 150 cases and 200 controls to optimise the test protocol and to establish test performance. We are also encouraged that a number of additional promising complementary EVOC probes are in our development pipeline, further enhancing our ability to address this high clinical need area.”

Lung cancer remains one of the most common forms of cancer across the world, with 2.21 million new cases in 2020. It is also a leading cause of death, with 1.8 million dying from the condition during 2020.