A team of researchers has successfully developed a cost-effective CRISPR-based diagnostic tool, FELUDA, to detect Helicobacter pylori (H. pylori) infections and their antibiotic resistance mutations in dyspeptic patients, particularly in rural areas with limited access to diagnostic laboratories.
H.pylori infections, which affect over 43% of the global population, are linked to various gastrointestinal disorders, including gastritis, peptic ulcers, dyspepsia, and gastric cancer. Resistance to clarithromycin—a key antibiotic for treating H. pylori—has emerged as a significant global health challenge due to mutations in the 23S ribosomal RNA gene, leading to repeated testing and multiple antibiotic regimens for effective treatment.
In a groundbreaking study, Dr. Shraddha Chakraborty from IIT Delhi, along with researchers from CSIR-IGIB and clinical collaborators from AIIMS New Delhi and Bhubaneswar, explored the potential of an engineered Cas9 protein (en31-FnCas9) to detect H. pylori infections and identify clarithromycin resistance mutations. Unlike traditional CRISPR-Cas9 tools that require specific PAM sequences, en31-FnCas9 was engineered with modified PAM binding affinity, enabling it to overcome these limitations.
The study, published in the Microchemical Journal, demonstrated the effectiveness of en31-FnCas9 in detecting H. pylori and its mutations in gastric biopsy samples through in vitro cleavage studies and lateral flow-based test strip assays. The FELUDA-based lateral flow assay provided rapid, visually interpretable results, making it a practical tool for clinical and remote settings.
“This sequencing-free molecular diagnostic approach offers a significant advancement in detecting H. pylori and its antibiotic resistance mutations, enabling tailored treatment plans and addressing public health challenges associated with antibiotic resistance and gastric cancer,” the researchers noted.
As reported by medicalbuyer, this marks the first successful report of en31-FnCas9-mediated molecular diagnosis of H. pylori mutations linked to clarithromycin resistance. If implemented widely, this method could provide accurate, timely antibiotic resistance profiles in resource-limited regions, ensuring effective management of H. pylori infections and reducing the burden of gastric diseases globally.