Exalenz Bioscience has started a clinical study to investigate its BreathID test to non-invasively detect primary liver cancer, also known as hepatocellular carcinoma (HCC).
Being conducted initially at the 302 Military Hospital of China, the 100-patient study will test the efficacy of BreathID for the early detection of HCC, compared to magnetic resonance imaging (MRI). The study will progressively be conducted at multiple sites across the country.
Study principal investigator Yongping Yang said: "Accurately diagnosing liver cancer has been historically difficult because the disease often has no observable symptoms in its early stages and due to the dearth of non-invasive, efficient diagnostic tools.
"We are encouraged by the potential of BreathID as a new option for clinicians and patients for detecting liver cancer particularly in markets and institutions where conventional diagnostic technologies are not economically or practically feasible."
Exalenz Biosciences CEO Larry Cohen said: "The Exalenz BreathID test has shown promising early evidence of efficacy as a detection tool for liver cancer patients, offering a non-invasive, convenient and cost-effective alternative to currently available technologies."
After completion, the study further plans to explore a pivotal study and submit data to both the US and Chinese Food and Drug Administration to secure marketing approval.
Exalenz validated the efficacy of the breath test in a prior clinical study demonstrating a high correlation with imaging tests such as computed tomography that are currently the standard of care.
The company estimates the market value of this test to be nearly $380m in China alone.
The study forms part of Exalenz's growing clinical pipeline of investigational diagnostic applications for serious liver diseases.
In May 2015, the company initiated a clinical study testing the potential of its BreathID test to diagnose non-alcoholic steatohepatitis, and had an ongoing pivotal study investigating BreathID as a tool to diagnose clinically significant portal hypertension (CSPH).