A recent study carried out by researchers at Tulane University and published in the American Journal of Respiratory and Critical Care Medicine has unveiled a novel diagnostic tool that can identify Mycobacterium avium complex (MAC) nontuberculous mycobacterial (NTM) infections in as little as two hours. The CRISPR-based assay significantly accelerates the current diagnostic process, which can last for months and could revolutionise the way NTM infections are diagnosed.

NTM refers to infection with a group of bacteria within the Mycobacterium genus, which excludes Mycobacterium tuberculosis (tuberculosis) and Mycobacterium leprae (leprosy). MAC bacteria naturally reside in soil and water, including airborne soil/dust particles and water in the home. Exposure to MAC bacteria occurs daily, but for most healthy individuals it does not result in an infection. Conversely, NTM are opportunistic pathogens that are responsible for causing infections in patients with pre-existing health conditions or compromised immune systems. According to primary research conducted by GlobalData in 2022, MAC is responsible for the majority of NTM pulmonary disease (NTM-PD) cases. In the US, MAC can be attributed to 78%–85% of prevalent NTM-PD cases.

Symptoms of NTM-PD include cough with sputum production, fever, weight loss, fatigue, respiratory insufficiency, and coughing up blood. NTM-PD is notoriously difficult to diagnose due to the slow growth of the bacteria, as well as notoriously difficult to treat due to the long course of treatment that is required and the ability of the bacteria to become treatment-refractory.

The CRISPR-based assay works by measuring MAC cell-free DNA (MAC-cfDNA) levels within patient blood samples. This cell-free DNA is released by the MAC bacteria into the host’s bloodstream during immune-mediated cell lysis, thereby providing the opportunity for a minimally invasive diagnostic approach. The test can yield results in as little as two hours, and the published preliminary findings reported that the test was able to accurately identify more than 93% of patients with an NTM infection, with the assay exhibiting 97.6% sensitivity and 97.6% specificity. This is in stark contrast to the current diagnostic process, which relies on an analysis of the slow-growing bacterial cultures.

The development of a CRISPR-based MAC NTM assay is revolutionary. By providing patients with a quicker diagnosis, this also opens the door for rapidly deploying treatment. According to key opinion leaders (KOLs) interviewed by GlobalData in 2022, a prominent unmet need in the NTM market is reaching successful treatment endpoints. This is increasingly important, as NTM infections have been and are expected to continue rising annually due, in part, to global climate change. According to GlobalData epidemiologists, NTM cases in the US are projected to increase at an annual growth rate (AGR) of 1.74% between 2021–2031. Similarly, NTM cases in the UK and Japan are projected to increase at an AGR of 0.89% and 0.40%, respectively, during the same forecast period.

Reaching successful treatment endpoints begins with an accurate initial diagnosis, followed by optimal treatment. The development of the CRISPR-based assay is a milestone achievement for NTM patients and the NTM market. Another key milestone would be for this technology to be expanded to include the identification of other NTM species, and eventually be optimised as a point-of-care test.

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