The leader in the breath biopsy field announced on Thursday last week (November 9) the results of a peer-reviewed study in the journal Biomedicines called ‘Exogenous Volatile Organic Compound (EVOC) Breath Testing Maximizes Classification Performance for Subjects with Cirrhosis and Reveals Signs of Portal Hypertension’.
The study enrolled 29 ultrasound-confirmed cirrhosis cases and 29 healthy controls to assess the performance of Owlstone’s EVOC limonene breath test in cirrhosis detection.
Owlstone found that the food manufacturing industry used limonene. It is deemed a safe chemical ingested mainly through the diet and accumulates in the liver with a small amount excreted in the breath following elevated exposure. In the study, all subjects showed a greater than 100-fold limonene spike in breath after administration of the limonene EVOC probe, with significantly higher bioavailability seen in the cirrhosis group.
Optimal test performance for detecting cirrhosis was seen at 60 minutes post-administration, a performance that suggests it has utility for screening.
The company is developing non-invasive, easy-to-use, breath tests for liver disease, including for the early detection of cirrhosis. This test is planned to be used in primary care to screen individuals at high risk of having liver cirrhosis, with administration of the EVOC probe and collection of the sample to be performed in-clinic and analyzed in a Breath Biopsy laboratory. Individuals with a positive test would then be expected to undergo further clinical diagnostic testing in line with the current clinical care pathway for formal diagnosis.
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Compared to current approaches for cirrhosis detection available in primary care, Breath Biopsy offers several advantages. Breath collection is simple which enables it to be collected without the need for significant capital investment or specialist training.
“Further, the breath test in the study out-performs existing blood-based tests and is non-invasive and cost-effective. Given the simplicity of Breath Biopsy, this published study demonstrates, for the first time, the potential of breath analysis as the basis of a non-invasive screening test that can be implemented in primary care to enable the early detection of cirrhosis with high sensitivity and specificity.”