IntelliGenome, a molecular diagnostic solutions provider, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CRISPR-Tuberculosis (TB) Blood Test. This diagnostic tool represents a significant advancement in TB detection, utilizing CRISPR technology to identify Mycobacterium tuberculosis (Mtb) cell-free DNA in human serum and EDTA plasma through a real-time polymerase chain reaction (PCR) assay.
The CRISPR-TB Blood Test is designed to detect low concentrations of Mtb cell-free DNA (cfDNA) in blood samples, a concept that originated from over a decade of research by Professor Tony Hu’s group at Tulane University. IntelliGenome has developed a molecular diagnostic platform capable of detecting low-abundance target nucleic acids in blood. This enables precise detection of disease-specific cfDNA, which is useful for early disease diagnosis and public screening.
Advantages of the CRISPR-TB Blood Test
The CRISPR-TB Blood Test is suitable for all patient groups, offering accurate, rapid, and cost-effective diagnosis of both pulmonary tuberculosis (PTB) and extra-pulmonary tuberculosis (EPTB). The test's platform directly identifies species-specific TB cfDNA sequences from blood samples. A key advantage is the elimination of sputum collection, addressing diagnostic challenges in vulnerable populations such as pediatric, geriatric, and critically ill patients.
Professor Tony Hu from Tulane University stated, "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."
FDA Breakthrough Devices Program
The FDA's Breakthrough Devices Program aims to accelerate the development, evaluation, and approval of innovative technologies that address irreversibly debilitating conditions. With the Breakthrough Device Designation secured by the end of 2024, IntelliGenome is preparing to accelerate its multicenter clinical study, with sites planned in the United States, Mexico, and Germany in 2025.
Wilson Zhang MD MSc, CEO of IntelliGenome, noted, "The FDA’s Breakthrough Device Designation for our CRISPR-TB Blood Test is a significant milestone for IntelliGenome. This recognition highlights our commitment to advancing innovative, accessible solutions for tuberculosis diagnosis and improving patient outcomes."
