The test uses a molecular diagnostic platform to detect Mycobacterium tuberculosis DNA in blood samples, providing a non-invasive method for diagnosing pulmonary and extrapulmonary tuberculosis.
RT’s Three Key Takeaways:
- FDA Breakthrough Designation Granted: IntelliGenome’s CRISPR-TB blood test received FDA Breakthrough Device Designation for its non-invasive method to detect Mycobacterium tuberculosis DNA in blood samples.
- Advanced Diagnostic Platform: The test uses CRISPR technology and a molecular diagnostic platform to identify low-abundance TB DNA, enabling precise diagnosis of pulmonary and extrapulmonary tuberculosis.
- Focus on Vulnerable Populations: By eliminating the need for sputum collection, the test aims to address diagnostic challenges in pediatric, geriatric, and critically ill patients.
IntelliGenome announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its CRISPR-Tuberculosis (TB) blood test.
This test is a qualitative real-time polymerase chain reaction assay that combines clustered regularly interspaced short palindromic repeats (CRISPR) technology, designed to detect Mycobacterium tuberculosis cell-free DNA in human serum and EDTA plasma.
The ability to detect low-abundant cell-free DNA of Mycobacterium tuberculosis in blood samples by using the 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, IntelliGenome has developed a 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.
The CRISPR-TB blood test is suitable for all patient groups and provides rapid and cost-effective diagnosis of both pulmonary tuberculosis and extrapulmonary tuberculosis. Intended for use in Clinical Laboratory Improvement Amendments-certified laboratories, the test’s platform identifies species-specific TB cell-free DNA sequences from blood samples. By eliminating the need for sputum collection, the company states 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,” says Hu, PhD, Tulane University, in a release.
The FDA Breakthrough Devices program aims to expedite the development, evaluation, and approval of innovative technologies designed to address irreversibly debilitating conditions effectively. IntelliGenome plans to accelerate its multicenter clinical study, with sites in the United States, Mexico, and Germany, in 2025.
ID 346172631 | Tuberculosis © Kateryna Kon | Dreamstime.com