Clinical Applications

 Pneumonia in the Emergency Department (PED)

  • Potent, broad spectrum antibiotics overprescribed by 30x for pneumonia patients seen in the emergency department due to a lack of rapid, point-of-care diagnostic tools and defensive medicine
  • Broad spectrum antibiotics typically administered by IV require hospitalization
  • Overuse of broad spectrum antibiotics has led to the rise of resistant strains of bacteria that are difficult to treat and long term health consequences for patients including severe diarrhea and death from C. difficile infections
  • Avisa BreathTest will detect pneumonia causing urease pathogens that typically require broad spectrum antibiotics to treat with a 10 minute, point-of-care test
  • Avisa BreathTest will provide timely information to emergency medicine physicians to aid antibiotic decision making in patients diagnosed with pneumonia
  • The Avisa BreathTest has the potential to reduce hospital admissions and drug costs due to the overuse of antibiotics and enhance antibiotic stewardship measures

Ventilator Associated Pneumonia (VAP)

  • In the US, 1.6 million intensive care patients on mechanical ventilation per year of which 23% develop VAP
  •  VAP increases length of stay, morbidity and mortality
  •  VAP is very costly due to empirical treatment with expensive antibiotics, increased length of stay and CMS reimbursement penalties
  •  Up to 70% of VAP cases caused by urease pathogens such as P. aeruginosa, S. aureus and Klebsiella
  • Avisa BreathTest integrated into ventilator circuit for breath collection and AV-U13 administration via Aerogen Solo nebulizer
  • Applications of the Avisa BreathTest in mechanically ventilated patients include:

  • Early detection of pulmonary infections to enable early intervention
  • Guidance of antibiotic choice for diagnosed VAP
  • Monitoring efficacy of VAP treatment

 

Future Clinical Applications

Chronic Obstructive Pulmonary Disease Exacerbations

  • 12 million patients diagnosed with COPD in USA
  • ~1.3 acute exacerbations per patient per year requiring emergency department visit or hospitalization
  • Pulmonary infections caused by urease pathogens responsible for up to 40% of acute exacerbations in COPD patients
  • Avisa BreathTest given to COPD patients at risk for acute exacerbations to potentially enable early detection, treatment and avoidance of hospital
  • Avisa BreathTest does not require sputum so applicable to more COPD patients
  • Test takes < 10 minutes from start to finish, delivering answer at point-of-care
  • Avisa BreathTest also applicable to patients with cystic fibrosis and bronchiectasis

Tuberculosis

  • 9 million incident cases of active TB each year, predominantly in developing countries
  • Mycobacterium tuberculosis is a known urease pathogen found in the lungs
  • Avisa BreathTest will act as a triage test for patients suspected of having active TB (90 million)
  • Avisa BreathTest does not require a sputum sample, so applicable to a broader array of suspected pulmonary TB cases including children
  • Test takes < 10 minutes from start to finish, delivering immediate answer at point-of-care
  • Potential for fewer TB patients lost to follow-up and less contact exposure due to immediate results of Avisa BreathTest

The Avisa BreathTestTM is currently an investigational device and has not yet been approved by the FDA for commercial use.