To detect low-abundant CfDNA of Mtb in blood samples by using the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) diagnostic technology, is the culmination of over a decade of research by Professor Tony Hu’s research group at Tulane University. Building on this innovation, IntelliGenome has developed the world’s first molecular diagnostic platform capable of detecting low-abundance target nucleic acids in blood. This platform allows for highly precise detection of disease-specific cell-free DNA (cfDNA), making it ideal for early disease diagnosis and public screening.

The CRISPR-TB Blood test is suitable for all patient groups and provides accurate, rapid, and cost-effective diagnosis of both pulmonary tuberculosis (PTB) and extra-pulmonary tuberculosis (EPTB). Intended for use in CLIA-certified laboratories, the test’s highly sensitive platform directly identifies species-specific TB cell-free DNA (cfDNA) sequences from blood samples. By eliminating the need for sputum collection, it overcomes challenges in diagnosing vulnerable populations, including pediatric, geriatric, and critically ill patients.

“The FDA’s recognition of IntelliGenome’s CRISPR-TB Blood Test as a Breakthrough Device is a testament to the transformative potential of CRISPR-based diagnostics. It’s rewarding to see innovative science like this making a tangible difference in healthcare.” – Professor Tony Hu, Tulane University.