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: Jack_Davis@intelligenome-us.com
Website: www.intelligenome-us.com
Media Contact: Krystal
Tu
Media Contact Email: 388988@email4pr.com
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SOURCE IntelliGenome
