Avisa Pharma announced tthat it successfully detected active TB in a pilot study in Durban, South Africa.
The study had three cohorts, suspected TB subjects who were HIV negative, suspected TB subjects who were HIV positive and controls. The AV-BreathTest™ detected TB in both HIV+ and HIV- cohorts confirmed by PCR and standard TB culture.
The AV-BreathTest measures the whole lung, in vivo, does not require sputum, and is point-of-care. The time from test initiation to result is less than 10 minutes, and the breath test has the potential to monitor antibiotic therapy.
There are 9.5 million active TB cases worldwide, of which 1 million are children who have difficulty producing sputum and require traditional tests with more invasive procedures.
According to David S. Joseph, Avisa’s President and CEO, "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.
Moreover, 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."
Avisa is a clinical stage company that is developing an exciting, next-generation biomarker platform technology that enables the rapid detection of a variety of respiratory pathogens within minutes after the patient inhales its proprietary drug substrate, AV-U13.
Upon receipt of its first FDA approval, the company plans to initiate additional clinical studies for ventilator associated pneumonia (VAP), chronic obstructive pulmonary disease (COPD), healthcare acquired pneumonia (HCAP) and cystic fibrosis (CF).