T2 Biosystems Seeks FDA Breakthrough Device Designation for Candida Auris Diagnostic Test Submission
Tuesday, June 06, 2023
T2 Biosystems, a prominent company specializing in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, has recently announced its submission of an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation. This application pertains to T2 Biosystems' Candida auris test, which the company plans to integrate into its FDA-cleared T2Candida® Panel.
Candida auris (C. auris) is a highly drug-resistant fungal pathogen that poses a significant global health threat, according to both the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). The mortality rate associated with C. auris can reach up to 60%, making it a serious concern. The CDC has labeled C. auris as an urgent antimicrobial resistant threat due to its challenges in identification using conventional laboratory methods, its resistance to available antifungals, its ease of transmission in healthcare settings, and its potential to cause severe infections with high mortality rates. The CDC estimates that fungal diseases in the United States alone incur annual costs of up to $48 billion, emphasizing the importance of early detection and appropriate treatment to mitigate this burden.
T2 Biosystems aims to obtain FDA Breakthrough Device Designation for its innovative Candida auris diagnostic test, which directly detects the pathogen from blood samples. The designation, if granted, would expedite the process of FDA clearance and subsequent commercialization. John Sperzel, Chairman and CEO of T2 Biosystems, expressed confidence that their T2Candida Panel, the only FDA-cleared diagnostic capable of rapidly detecting sepsis-causing fungal pathogens directly from blood within a span of 3-5 hours, without the need for positive blood culture results, could be enhanced by incorporating C. auris detection. Such a development would provide healthcare professionals with prompt results, facilitating targeted antimicrobial treatment and aligning with the CDC's recommendations.
The T2Candida Panel, compatible with the automated T2Dx Instrument, is the sole FDA-cleared diagnostic test designed to identify sepsis-causing fungal pathogens directly from whole blood, eliminating the waiting time for blood culture confirmation. This panel can simultaneously detect five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. The rapid detection of these pathogens, in addition to Candida auris, is crucial for promptly initiating appropriate antimicrobial therapy and improving clinical outcomes.
The FDA's Breakthrough Devices Program is a voluntary initiative for medical devices and device-led combination products that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This program expedites the development, assessment, and review of qualifying devices while maintaining the FDA's standards for approval and marketing authorization, ultimately enabling patients to access these medical advancements in a more timely manner.