Biomarker for Low-Risk NTM Infection in the Airway of Cystic Fibrosis Patients

Opportunity

Available for Licensing

IP Status

US Patent: 17/778,355

Inventors

Delphi Chatterjee
Jerry A Nick

Reference No: 2020-072

Licensing Manager

Jessy McGowan
Jessy.McGowan@colostate.edu
970-491-7100

At a Glance

Researchers at Colorado State University in collaboration with National Jewish Health have developed a novel non-invasive first screening tool to segregate patients for which Nontuberculous mycobacteria (NTM) sputum cultures are not needed. This test measures urine LAM by gas chromatography–mass spectrometry using a urine sample handling protocol wherein LAM is separated from other endogenous neutral polysaccharides, developed to successfully increase the specificity and sensitivity of the test.

Background

Cystic fibrosis (CF) is a progressive, chronic disease characterized by the production of thick, sticky mucus that clogs the lungs and creates an ideal environment for bacterial colonization. As such, Nontuberculous mycobacteria (NTM) has been identified as the greatest risk for those afflicted by CF, but the lack of sensitive and specific markers of NTM in the airway is a significant barrier for patient care. Currently, the only method of screening is through direct culture from the airway. Sadly, this gold standard diagnosis procedure has several limitations, including slow growth (up to 8 weeks), high cost, and low sensitivity. Furthermore, CF sputum samples contain bacterial co-pathogens, resulting in false negative results.

Lipoarabinomannan (LAM), however, is a cell wall lipoglycan found in all mycobacteria species that is released into circulation from metabolically active or degrading bacteria. It has recently gained attention as a biomarker for active tuberculosis as it is found in the urine of infected patients. LAM has potential to be utilized for non-invasive screening for those with potential risk of NTM.

Benefits

Noninvasive
Significant correlation between the presence of LAM in urine and a history of NTM has been demonstrated in a well characterized CF population
High specificity and sensitivity

Applications

NTM screening and diagnostic for at risk populations (including CF)

Publications

JA Nick, et al. (2022) Host and Pathogen Response to Bacteriophage Engineered Against Mycobacterium abscessus Lung Infection. Cell. doi: 10.1016/j.cell.2022.04.024

Y Panraksa, et al. (2021). Immobilization of Proteinase K for urine pretreatment to improve diagnostic accuracy of active tuberculosis. Plos One. https://doi.org/10.1371/journal.pone.0257615

P De, et al. ( 2020) Urine lipoarabinomannan as a marker for low-risk of NTM infection in the CF airway. J Cyst Fibros. doi: 10.1016/j.jcf.2020.06.016.

Last updated: June 2023