US-based Avisa Pharma has successfully detected active tuberculosis (TB) using a new breathe test in a pilot study conducted in Durban, South Africa.
The AV-BreathTest has been developed to rapidly screen and detect active tuberculosis in less than 10min.
The test detects bacterial lung infections by using its platform, which is the non-radioactive stable isotopic ratio of 13C and 12C.
The point-of-care test is designed to measure the whole lung, monitor antibiotic therapy, and provide a result.
Avisa president David S. Joseph said: "This pilot study allows us to plan our pivotal clinical trials to be held in 2017 on multiple continents for regulatory approvals.
"Early screening triage and detection by our breath test biomarker can substantially reduce the spread of this terrible disease; reduce the need for time-consuming, low-sensitivity smear microscopy; and identify active TB in those patients with symptoms that have difficulty in producing sputum for culture or PCR detection.
"Since the test is less than 10 minutes, monitoring efficacy of antibiotic therapy is another potential benefit of our technology given the major concern of multidrug resistance."
The company studied three cohorts using HIV negative patients, along with suspected HIV positive TB subjects, and control patients.
Avisa used AV-BreathTest to detect TB in both HIV positive and negative cohorts. This was confirmed by PCR and standard TB culture.
Avisa noted that there are 9.5 million active TB cases worldwide, of which one million are children who have difficulty producing sputum, and require traditional tests with more invasive procedures.