Contact: David Joseph
Avisa Pharma, Inc.
Phone: (505) 820 1400
Fax: (505) 226 1500
dsj@avisapharma.com
1660A Old Pecos Trail
Santa Fe, NM 87505
www.avisapharma.com
PressRelease
Avisa’s Biomarker Breath Test Detects Tuberculosis in South Africa Pilot Study
A ten minute breath test for rapid screening and detection of active tuberculosis
Santa Fe, NM, December 18, 2015: Avisa Pharma Inc. announced today that 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 requiring traditional test procedures that are more invasive.
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 multi-drug resistance.”
ABOUT AVISA
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).
The
company believes early detection will lead to lower healthcare costs. Avisa licensed its core breath test
technology with the University of New Mexico’s Science Technology Center (UNM-STC).
Avisa has its
AVISAR SPEC™ laser spectrometer under development that incorporates major design advancements – a
point-of-care, laptop size, 3 in. height, battery powered device that can fit into a backpack for rural health
clinics in high burden countries, outpatient clinics, hospital inpatient and ICU/CCU units, emergency
departments, urgent care centers, retail clinics and long term care facilities.