IntelliGenome accelerates CRISPR-PCR TB testing studies

Blood Test Samples Lab (2)

IntelliGenome's CRISPR-Tuberculosis (TB) Blood Test has received the breakthrough device designation from the U.S. Food and Drug Administration (FDA), the company announced.

Having received FDA guidance and the breakthrough designation, IntelliGenome said it will accelerate its multicenter clinical study at sites in the U.S., Mexico, and Germany this year.

The test is the first qualitative real-time polymerase chain reaction (PCR) assay to combine CRISPR technology, IntelliGenome said. The company added that the test is suitable for all patient groups, eliminates the need for sputum collection, and addresses diverse forms of TB.

TB is challenging to diagnose, still widely dependent on smear microscopy and culture, which both take time, according to IntelliGenome. However, the Houston-based company, founded in July 2022, has engineered a probe that identifies a sequence of DNA that is unique to the bacteria that causes TB in humans.

When the CRISPR probe attaches to that particular DNA segment, a fluorescent marker is activated, signaling not only the presence of the bacteria in the sample but also the volume of bacteria in the sample, according to IntelliGenome. The company has promised results in 30 minutes compared to other TB testing methods.

IntelliGenome's CRISPR-PCR molecular assay is designed to detect low-abundance target nucleic acids in blood by targeting Mycobacterium tuberculosis cell-free DNA in human serum and ethylenediaminetetraacetic acid plasma. In its statement, IntelliGenome credited the technology to the Tony Hu research laboratory at Tulane University in New Orleans, LA.

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