Nasdaq-listed in vitro diagnostics firm T2 Biosystems has obtained clearance from the US Food and Drug Administration (FDA) to market its T2Candida Panel for paediatric patients.
T2 Biosystems, which focuses on rapid detection of sepsis-causing pathogens and antibiotic resistance genes, plans to begin marketing and selling the T2Candida Panel under the expanded paediatric claim immediately.
The T2Candida Panel is said to be the only FDA-cleared diagnostic test that can detect Candida species, which cause sepsis, directly from blood within three to five hours. It does not require waiting for a positive blood culture.
The panel runs on the T2Dx Instrument, also cleared by the FDA, and detects five Candida species, which are Candida albicans, Candida parapsilosis, Candida tropicalis, Candida glabrata, and Candida krusei.
According to the US Centers for Disease Control and Prevention (CDC), these five species account for up to 95% of Candida bloodstream infections in the US.
T2 Biosystems chairman and CEO John Sperzel said: “This FDA clearance marks another important milestone in our commitment to expand the clinical utility of our sepsis test panels and allows our commercial team to immediately begin marketing and selling our test to over 200 children’s hospitals in the US.
“Studies show that the T2Candida Panel detects Candida species significantly faster, and with greater sensitivity, when compared to blood culture-based diagnostics, and we believe the new pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.”
A study in the Journal of Clinical Microbiology (2022), conducted at the Bambino Gesù hospital in Rome, Italy, found that paediatric patients suspected of fungal bloodstream infections tested with the T2Candida Panel received results 121.8 hours faster than those tested by blood culture.
The study also showed a higher detection rate with the T2Candida Panel, identifying six additional probable or possible fungal bloodstream infections that were not detected by blood culture.
A prospective observational study, published in Clinical Infectious Diseases (2022), examined four pre-blood culture tests for detecting invasive candidiasis in paediatric patients. It found that the T2Candida Panel had the highest sensitivity and specificity among the four assays tested in a group of five hundred patients.
The study recommended the T2Candida Panel as the only test suitable for individual use in diagnosing invasive candidiasis in at-risk adolescents and children.
In July 2024, T2 Biosystems signed a territory exclusive distribution agreement in Malaysia and Indonesia. As per the agreement terms, the firm will sell the T2Dx Instrument, the T2Bacteria Panel, the T2Resistance Panel, and the T2Candida Panel via the newly appointed distributor.
