Biomarker for Low-Risk NTM Infection in the Airway of Cystic Fibrosis Patients
Available for Licensing
PCT Patent Pending: WO 2021/127096
Jerry A Nick
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.
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.
- 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
- NTM screening and diagnostic for at risk populations (including CF)
De P, Amin AG, Graham B, Martiniano SL, Caceres SM, Poch KR, Jones MC, Saavedra MT, Malcolm KC, Nick JA, Chatterjee D. Urine lipoarabinomannan as a marker for low-risk of NTM infection in the CF airway. J Cyst Fibros. 2020 Sep;19(5):801-807. doi: 10.1016/j.jcf.2020.06.016. Epub 2020 Jul 3. PMID: 32624408; PMCID: PMC7492412.
Last updated: Sept 2021