Biomarkers for Diagnosis and Treatment Management of Tuberculosis


Biomarkers to diagnose active and latent tuberculosis infection and monitor treatment regimen.

Key Benefits

  • Three biomarkers accurately distinguish active tuberculosis (TB) from latent TB infections with 100% specificity and greater than 96% sensitivity.
  • Faster and more accurate test to monitor treatment response among active tuberculosis patients.
  • Uses blood samples instead of sputum samples that are more difficult to obtain in some patient population.

Market Summary

Tuberculosis (TB) remains a serious global health problem. Current diagnostic tests rely on direct smear examination and culture of the respiratory samples. Smear tests fail to diagnose up to 66% of TB cases and culture tests of sputum for Mycobacterium tuberculosis take 4-6 weeks for results. There is an urgent need for reliable and inexpensive tools that can rapidly and accurately identify patients with active TB disease in order to begin treatment promptly. An effective diagnostic would also need to evaluate response to treatment. Because treatment regiments for patients with active and latent TB infections are different, an effective diagnostic test must also reliably distinguish individuals with active TB from those with a latent TB infection.

Technical Summary

Although many tests, like host T cell-based tests, can diagnose Mycobacterium tuberculosis (Mtb), they fail to distinguish between active TB and latent TB infection. Emory inventors have identified three biomarkers that predict active TB and latent TB infection status. Expression of these biomarkers, CD38, HLA-DR and Ki-67, was significantly higher on Mtb-specific, IFN-y+ CD4 T cells in individuals with active TB compared to those with latent TB infection. They accurately distinguish active TB from latent TB infections with 100% specificity and higher than 96% sensitivity. In addition, these biomarkers show potential as a gauge of Mtb load in patients suggesting that they may serve as biomarkers of treatment response in patients undergoing anti-TB treatment as well as in clinical trials of new therapeutics.

Developmental Stage

The specificity and sensitivity of the three biomarkers have been proven in 25 patients with latent tuberculosis infection and 25 patients with active tuberculosis in a test cohort and validated in an independent cohort.

Publication: Adekambi et al. 2015. J Clin Invest March 30

Patent Information

App Type Country Serial No. Patent No. File Date Issued Date Patent Status
Nationalized PCT - Foreign EP 15788649.0 3139922 11/2/2016 8/14/2019 Issued
EP Registered Country France 15788649.0 3139922 11/2/2016   Issued
EP Registered Country Germany 15788649.0 3139922 11/2/2016   Issued
EP Registered Country United Kingdom 15788649.0 3139922 11/2/2016   Issued
Nationalized PCT - United States United States 15/309,403 10,041,945 11/7/2016 8/7/2018 Issued
Nationalized PCT - Foreign South Africa 2016/08306   12/1/2016 5/27/2020 Issued
Tech ID: 14112
Published: 6/1/2015