T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today affirmed plans to add detection of the fungal pathogen Candida auris to the Company’s FDA-cleared and CE marked T2Candida® Panel.
According to a March 21, 2023 Wall Street Journal report, Candida auris is a multidrug-resistant pathogen labeled by the Centers for Disease Control and Prevention (CDC) and World Health Organization as a growing threat to public health. The report described Candida auris as a “deadly fungus spreading across the U.S., mostly in healthcare facilities,” and stated that Candida auris has a mortality rate of up to 60%, and that older people or those with compromised immune systems are at greater risk.
According to the CDC, Candida auris is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment, and that some strains are resistant to all three available classes of antifungal therapies. The CDC estimates the costs associated with fungal diseases in general in the U.S. are as high as $48 billion annually, and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early diagnosis and proper treatment.
“With prior support from the CDC, we have completed feasibility and early development of a diagnostic test to detect the Candida auris pathogen directly-from-blood and we plan to add this test to our FDA-cleared T2Candida Panel,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris detection to our existing T2Candida Panel can accelerate time to detection and targeted treatment, compared to blood culture-based diagnostic methods, and we are exploring partnerships to accelerate our path toward commercialization.”
The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from whole blood, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the fully-automated T2Dx® Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antimicrobial therapy and improving clinical outcomes.
Source: Company Press Release
