A groundbreaking innovation from IntelliGenome, a Houston-based biotechnology company, may revolutionize TB diagnosis through a novel CRISPR-powered blood test.
The U.S. Food and Drug Administration (FDA) has granted the CRISPR-TB Blood Test a Breakthrough Device Designation, a status reserved for medical technologies that offer significant advantages over existing standards of care.
“The FDA’s Breakthrough Device Designation for our CRISPR-TB Blood Test is a significant milestone for IntelliGenome,” said Dr. Wilson Zhang, MD, MSc, CEO of IntelliGenome. “This recognition highlights our commitment to advancing innovative, accessible solutions for tuberculosis diagnosis and improving patient outcomes.”
Despite various diagnostic advancements, timely and accurate TB detection has remained a challenge.
Traditional TB diagnostics, including smear microscopy and culture methods, often suffer from low sensitivity and slow turnaround times. Even newer assays such as ELISpot, ELISA blood assays, and standard PCR tests have struggled to make a widespread impact due to logistical and performance limitations.
Tuberculosis (TB) remains one of the deadliest infectious diseases worldwide, claiming 1.6 million lives annually and infecting over 10 million people each year.
IntelliGenome’s CRISPR-TB Blood Test addresses these challenges by providing a rapid, accurate, and cost-effective diagnostic solution. By detecting TB-specific cfDNA directly in blood samples, this test has the potential to facilitate earlier diagnosis, improve treatment outcomes, and aid global TB eradication efforts.
The CRISPR-TB Blood Test is the first real-time polymerase chain reaction (PCR) assay that integrates Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology to detect Mycobacterium tuberculosis (Mtb) cell-free DNA (cfDNA) in human serum and EDTA plasma. This breakthrough method eliminates the need for traditional sputum collection, making TB screening more accessible, particularly for vulnerable populations such as children, the elderly, and critically ill patients.
IntelliGenome has pioneered a molecular diagnostic platform capable of detecting low-abundance target nucleic acids in blood. This capability allows for precise detection of disease-specific cfDNA, making it an ideal tool for early diagnosis and large-scale public health screenings.
