A biomarker point-of-care test for rapidly detecting pulmonary infections

The Avisa BreathTestTM is a biomarker, 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.

How does it work?

Urease Converts 13C-urea to 13C02

Based on the presence of the urease enzyme

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 (13C02) and ammonia. The non-radioactive, isotopic ratio of 13C02 to naturally occurring 12C02 is measured in the exhaled breath of the patient and is akin to an infection thermometer for the lungs.

How is it different?

Results in less than 10 minutes

how1

Patient inhales nebulized AV-U13, 13C-urea

how2

Bacteria rapidly converts AV-U13, to 13CO2 that is exhaled

how3

AVISAR Laser Spectrophotometer measure 13CO2

how4

Point of care analysis in seconds

Quickly detects live urease pathogens anywhere in the lung within 10 minutes

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 AVISARTM, a point-of-care medical device that replaces much larger laboratory-based instrumentation typically used for measuring exhaled CO2.

 

Conveniently packaged in a disposable breath collection kit

The AV-U13 drug and nebulizer are conveniently packaged in a disposable breath collection kit. The Avisa BreathTestTM reports the quantitative difference in the 13C02 to 12C02 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.

Avisa BreathTestTM Kit

The Avisa BreathTest kit is a single-use, disposable kit
containing the following items:

  • Lyophilized AV-U13 drug
  • 3 ml pre-filled syringe of sterile water
  • Breath collection cannula
  • Aerogen Solo Mesh Nebulizer

AVISARTM

Laser spectrometer with nebulizer

Avisa is in the final stages of developing the AVISARTM instrument. The AVISARTM contains a touchscreen operator interface, nebulizer controller, breath sampling pneumatics and a laser spectrometer.

The AVISARTM rapidly measures breath 13C02/12C02 isotopic ratios using near infrared wavelength modulation spectroscopy enabled by a patented, tunable semiconductor laser.

Major design innovations have resulted in a compact, portable device weighing about 9 pounds (4 kg), 8.5 x 11 x 3.5 that is deployable in point­-of-care settings such as clinics, hospital wards and intensive care units.

Avisa BreathTest Procedure

The Avisa BreathTestTM has the following steps to perform a measurement:

  1. Retrieve and open the Avisa Breath Collection kit.
  2. Turn on AVISARTM, connect breath collection Link(TM) to instrument and give to patient to start breathing into.
  3. Mix the AV-U13 drug with 3 ml of sterile water provided in kit.
  4. Fill the nebulizer cup with AV-U13 solution and connect nebulizer control cable to AVISARTM.
  5. Collect a baseline breath sample from patient by pressing START on AVISARTM.
  6. Start nebulization by pressing NEB on AVISARTM.
  7. Observe patient for natural breathing technique as patient inhales AV-U13 mist from nebulizer.
  8. At end of nebulization, AVISARTM collects patient breath and reports change from baseline
  9. Collect nebulizer and breath collection Link(TM) from patient, and safely dispose along with the syringe and drug container.
  10. Note result in medical record, elevated results indicate active infection with urease pathogen.

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

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