Breath Test Proving Effective for Detection of Pulmonary Tuberculosis

March 5th, 2010 Editors Medicine, Public Health

Menssana Research, Inc is touting results from a trial testing its Breathscanner for diagnosing patients with active pulmonary tuberculosis. Menssana has developed technology that may bring breath testing for a variety of conditions, including the already FDA approved breath test for heart transplant rejection.
Some details about the technology from Menssana:

The Mycobacteria that cause pulmonary TB generate a very distinctive pattern of volatile organic compounds (VOCs) when grown in the laboratory. If these VOCs could also be detected in the breath of infected patients, it might provide a new method for detecting active infection with pulmonary TB.
The National Institutes of Health (NIAID) awarded Menssana Research a Phase I SBIR grant to test the feasibility of this idea. We analyzed breath VOCs in hospitalized patients who were being screened for pulmonary TB at New York University Medical Center, New York. We also analyzed the VOCs manufactured by Mycobacteria grown in the laboratory at Saint Vincents Medical Center, New York.
We found that breath biomarkers of oxidative stress clearly distinguished between the “sick” hospitalized patients and normal controls. Also, breath VOCs accurately identified the patients whose sputum samples grew Mycobacteria – the VOC biomarkers in breath and in sputum cultures were very similar (see pdf).
Based on these encouraging findings, NIH/NIAID awarded Menssana Research a Phase II SBIR grant to validate the breath test for pulmonary TB in a larger multicenter international study performed in San Diego, London, and two sites in the Philippines and Mexico. The results, soon to be published in the journal Tuberculosis showed that the breath test identified active pulmonary TB with 85% accuracy.
The US Air Force is currently funding a new study of a point-of-care breath test for active pulmonary TB that delivers results in minutes.

Abstract in journal Tuberculosis: Breath biomarkers of active pulmonary tuberculosis
Link: Menssaba breath test for pulmonary tuberculosis…
Press release: Breath Test for Pulmonary Tuberculosis …
Flashback: The Breathscanner 1.0…

Upcoming conferences

october

18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

Event Details

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

Time

october 18 (Thursday) - 19 (Friday)

Organizer

Compliance Online 80068SEM

Learn More

Calendar GoogleCal

18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada