CRISPR-Tuberculosis Blood Test gains FDA breakthrough designation

IntelliGenome announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its CRISPR-Tuberculosis Blood Test. The test is the first qualitative real-time polymerase chain reaction assay to combine CRISPR technology, designed to detect Mycobacterium tuberculosis cell-free DNA in human serum and EDTA plasma.

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, making it ideal for early disease diagnosis and public screening, according to the company.

"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 health care,” said Hu, in a statement.

The CRISPR-TB Blood test is suitable for all patient groups and provides accurate, rapid, and cost-effective diagnosis of both pulmonary tuberculosis and extra-pulmonary tuberculosis. Intended for use in CLIA-certified laboratories, the test's highly sensitive platform directly identifies species-specific TB cell-free DNA 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 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," said Wilson Zhang, M.D., MSc, CEO of IntelliGenome, in a statement.

The FDA Breakthrough Devices Program aims to expedite the development, evaluation, and approval of innovative technologies designed to address irreversibly debilitating conditions effectively. With FDA guidance and the Breakthrough Device Designation secured by the end of 2024, IntelliGenome is well-positioned to accelerate its multicenter clinical study, with sites in the United States, Mexico, Germany in 2025.