IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test

HOUSTON, Jan. 21, 2025 /PRNewswire/ -- IntelliGenome, an innovative molecular diagnostic solutions provider, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its CRISPR-Tuberculosis (TB) Blood Test. This test is the first qualitative real-time polymerase chain reaction (PCR) assay to combine CRISPR technology, designed to detect Mycobacterium tuberculosis (Mtb) 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 (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.

"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." – Wilson Zhang MD MSc, CEO of IntelliGenome.

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.

About IntelliGenome

IntelliGenome is a Houston-based molecular diagnostic solutions provider founded in July 2022. The mission is to advance disease detection and treatment by commercializing the CRISPR detection platform technology. The advanced platform facilitates precise direct measurement and quantification of active disease elements, offering healthcare providers essential insights for treatment monitoring and the optimization of drug efficacy.

By harnessing the power of CRISPR technology, we are revolutionizing the field of disease diagnostics. For more information, please visit: www.intelligenome-us.com

Business Contact:

Jack Davis
Email: [email protected]
Website: www.intelligenome-us.com

Media Contact: Krystal Tu
Media Contact Email: [email protected]

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SOURCE IntelliGenome