Breath Test for TB
Summary
Specific volatile biomarkers to detect Tuberculosis (TB) infection.
Otago Innovation has a suite of TB biomarkers that will improve suspicion-initiated diagnosis of TB. It has been demonstrated that a breath test using our markers detects the volatile biomarkers for TB. A TB-breathtest using our technology will allow fast and accurate diagnosis of TB infection. The test could be adopted for TB screening.
Technology
Otago researchers discovered specific volatile biomarkers unique to Mycobacterium tuberculosis and Mycobacterium bovis and the markers were not identified in any of the other 115 respiratory pathogens tested. The volatile biomarkers are currently detected using GC-MS/MS technology. We have detected the markers in the head (gas) space of cultures of more than 30 M.tb/ bovis strains and serum samples from the World Health Organisation TB Specimen bank. We have also demonstrated specificity among TB patients in Madang, Papua New Guinea.
Patents for the volatile TB biomarkers have been filed.
Application
Current quality and timeliness of TB diagnostics depends strongly on the sample quality. The World Health Organisation estimates that US$1 billion are spent globally on TB diagnostics, including US$326 million in low-income countries. Of this $1 billion, US$231 million is spent on TB culture analysis with US$168 million in “western settings”. The current gold standard of TB diagnosis is microscopy of specimen cultures, as no other diagnostic test provides the required sensitivity and specificity. For example, sputum samples with low Mycobacterium tuberculosis concentration (“Smear negative”) can only be reliably identified after time-consuming specimen cultures because Mycobacterium tuberculosis grows slowly. This can take up to several weeks. Currently, we can detect biomarkers in the culture head-space in at least 50% of cases.
TB biomarkers from TB patients’ breath have been detected on GC-MS/MS. With appropriate solutions to store and transport breath samples, or collect biomarkers and/or customized GC-MS/MS technologies, the TB-breathtest will be suitable for centralised laboratories, TB-reference laboratories, or clinical laboratories.
To develop a portable point-of-care device, the “TB-breathalyser”, we require engineering and gas sensing expertise.
Partnership
Otago Innovation is seeking partners that can contribute towards product development for centralized or “on-site” laboratories as well as for point-of-care devices. In addition to funding, we are looking for partners who have one or more of following attributes: Expertise in VOC assay development; engineering capabilities and/or ownership of suitable sampling or detection technologies; existing products/services for human body specimen (fluid/gas) analysis; capabilities or established partnerships for product development, manufacturing, and/or sales.
Contact
Dr Alexandra Tickle
Otago Innovation Limited
PO Box 56
Dunedin. New Zealand
Tel 64 3 479 4145
Email alexandra.tickle@otagoinnovation.com
Intellectual Property
DETECTION OF VOLATILE COMPOUNDS AS MARKERS FOR MYCOBACTERIA TUBERCULOSIS
International Patent Application No. PCT/NZ2008/000261 (Priority Date 05 October 2007)
Presentation
Dr Alexandra Tickle presented the technology at NZ Bio 2009 in Auckland, New Zealand.
http://nzbio2009.co.nz/speaker/alex-tickle-otago-innovation-ltd
Publications
The scent of Mycobacterium tuberculosis--part II breath.
Syhre M, Manning L, Phuanukoonnon S, Harino P, Chambers ST.
Tuberculosis (Edinb). 2009 Jul;89(4):263-6. Epub 2009 May 29.
The scent of Mycobacterium tuberculosis.
Syhre M, Chambers ST.
Tuberculosis (Edinb). 2008 Jul;88(4):317-23. Epub 2008 Mar 4.