December 13, 2023 -- Luye Diagnostics Group today announced that Great Basin Toxigenic C. difficile Direct Test (CDF2), independently developed by Vela Operations USA, has been approved by U.S. Food and Drug Administration (FDA) for the detection of toxigenic Clostridioides difficile in unformed (liquid or soft) stool samples collected from two-year or older patients suspected of having C. difficile infection (CDI), thus assisting clinical diagnosis and treatment.
Liu Aona, Chairperson of Luye Diagnostics Group said: “Clostridium difficile infection is becoming increasingly common and due to long and expensive diagnostics procedure, patients often suffer while waiting. In the United States alone, more than 1 million Clostridium difficile toxin gene amplification tests are performed every year, with an average annual cost of a whopping US$226 million. However, patients and the industry have been struggling with how to detect Clostridium difficile infection with a sensitive, specific, fast and economical method. We are excited to see the approval of Great Basin Toxigenic C. difficile Direct Test (CDF2) in the U.S., which will hopefully benefit more patients in the future.”
Clostridioides difficile is a commensal bacterium of the human intestine and is a component of the normal intestinal flora for 10-20% of healthy adults. Under normal conditions, C. difficile does not pose a specific health problem. However, after a colonized individual has been treated with certain antibiotics or anti-neoplastic agents, the disruption of normal flora may allow C. difficile to become the predominant bacteria in the colon leading to C.difficile infection (CDI). CDI has significant clinical impact especially on the elderly and immunocompromised patients. In the United States, approximately 200,000 people become infected with C. difficile in hospitals or nursing facilities each year, and approximately 170,000 infections occur outside of health care institutions. If untreated, CDI can lead to debilitating diarrhea, sepsis, and ultimately death.
Prompt diagnosis of CDI can allow for the physician to initiate appropriate therapy. The pathogenesis of Clostridioides difficile is primarily mediated by two toxins: an enterotoxin coded by the C. difficile Toxin A gene (tcdA), and a cytotoxin coded by the C. difficile Toxin B gene (tcdB). C. difficile diagnosis has traditionally been done by labor intensive microbial culture procedures, followed by cell cytotoxicity assay testing of the isolates. Two large protein toxins (TcdA and TcdB) are the primary indicators of virulence for C. difficile. Rapid immunoassays have been developed to detect both the Toxin A and Toxin B proteins but have shown reduced sensitivity and specificity when compared to the culture-based testing method. More recently, development of molecular methods for the detection of C. difficile and C. difficile toxin genes (tcdB and tcdA) has resulted in diagnostic tests with increased sensitivity, improved specificity, and reduced testing time when compared to standard cell culture methods or previous rapid immunoassays.
The Great Basin Toxigenic C. difficile Direct Test, performed on the Great Basin PA500 Analyzer, is a qualitative in vitro diagnostic test for the detection of toxigenic Clostridioides difficile in unformed (liquid or soft) stool samples collected from patients suspected of having C. difficile infection (CDI). This is a highly sensitive, specific, fast and economical in vitro detection solution. Patients with suspected C. difficile infection can self-sample and submit them to a clinical laboratory for testing.
About Great Basin Great Basin Toxigenic C. difficile Direct Test (CDF2)
The Great Basin System is a fully automated, molecular diagnostic system that includes the PA500 Analyzer, single-use Toxigenic C. difficile Direct Tests, and integrated Great Basin data analysis software. The System is designed to perform automated sample preparation, polymerase chain reaction (PCR) amplification, and chip-based detection of assay targets with integrated data analysis.
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