Exalenz Bioscience Ltd. has received FDA approval to move forward with a clinical trial evaluating its experimental liver cancer-detecting breath analyzer, Globes reports.
Liver cancer, or hepatocellular carcinoma, is currently the sixth most common form of cancer worldwide and continues to increase in prevalence, notably among people living with chronic hepatitis B or hepatitis C. It’s also the third most deadly, with an annual death toll of 700,000.
The clinical trial of the breath analyzer, dubbed BreathID, will enroll 100 patients at five medical centers—three in the US and one each in Canada and Israel—and is slated to begin in the fourth quarter of 2011.
In a preliminary trial which concluded in July, BreathID had a 93 percent match with the results from magnetic resonance imaging (MRI) and computed tomography (CT) scans. If the clinical trial succeeds and sufficient funding becomes available, Exalenz plans to market BreathID as a replacement for ultrasound and CT/MRI testing currently used to detect liver cancer.
In addition to selling BreathID in the United States, the company hopes to promote their product in Asia, where the prevalence of hepatitis B and cirrhosis puts as much as ten percent of the continent’s population at risk for liver cancer. The resultant market is estimated to be worth hundreds of millions of dollars.