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T2 Biosystems announced that it has received marketing clearance from the Food and Drug Administration (FDA) for their T2Candida Panel and T2Dx Instrument, the first blood test for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections.
T2Candida and T2Dx are the first diagnostic products powered by the proprietary magnetic resonance-based diagnostic technology platform T2MR. Together, the T2Candida and T2Dx can identify five common yeast pathogens that are the most lethal forms of common blood stream infections that can lead to sepsis: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei. T2Candida and T2Dx can identify the presence of these Candida specimens from a single blood specimen within three to five hours.
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The FDA reviewed T2Candida through its de novo classification process for certain novel low-to-moderate-risk medical devices. In a clinical study, T2Candida demonstrated a sensitivity of 91.1% and specificity of 99.4% with a mean time of 4.4 hours for a positive test result vs. 129 hours for blood culture and species identification, the current industry standard. The mean time for a negative result for T2Candida was 4.2 hours vs. 120 hours for blood culture.
For more information visit T2Biosystems.com.
