The Avisa BreathTestTM is a noninvasive, quantitative, point-of-care test for rapidly detecting pulmonary infections due to certain virulent pathogens without the need to collect and culture sputum or other biological samples. The Avisa BreathTestTM is based on the presence of the urease enzyme found in certain bacterial species that cause pneumonia, such as S. aureus, P. aeruginosa, Klebsiella and H. influenzae. Live urease-containing bacteria can be detected using inhaled 13C-urea which is converted by these bacteria to labeled carbon dioxide (13CO2) and ammonia. The non-radioactive, isotopic ratio of 13CO2 to naturally occurring 12CO2 is measured in the exhaled breath of the patient and is akin to an infection thermometer for the lungs.
The primary differentiators of the Avisa BreathTestTM are its inherent ability to quickly detect live urease pathogens anywhere in the lung within 10 minutes; the use of a proprietary, nebulized 13C-urea (AV-U13) drug for inhalation; and the development of the AVISAR SPEC™, a point-of-care instrument that replaces much larger laboratory-based instrumentation typically used for measuring exhaled CO2. The AV-U13 drug and nebulizer are conveniently packaged in a disposable breath collection kit. The Avisa BreathTestTM reports the quantitative difference in the 13CO2 to 12CO2 ratio between baseline and post-nebulization breath samples in per mil units. Large differences in this ratio indicate an active pulmonary infection with a urease pathogen.
The Avisa BreathTestTM will be a major step forward in terms of speed and portability, making it suitable for use in clinics, hospital inpatient and intensive care units once FDA approval is received. The Avisa BreathTestTM will provide immediate information as to the presence of certain urease pathogens in the lung, potentially aiding clinical decision making regarding use and choice of antibiotics. It has the potential to support antibiotic stewardship efforts and complement conventional culture-based detection techniques that only sample limited regions of the respiratory tract, require sophisticated lab facilities and take one to two days for results.
The Avisa BreathTestTM is currently an investigational device and has not yet been approved by the FDA for commercial use.