FDA Green Lights Yeast Pathogen Detecting Blood Test

September 23, 2014

The FDA has approved the marketing of T2 Biosystem’s T2Candida yeast pathogen detecting blood test through its de novo classification process. The first-of-its-kind test detects five yeast pathogens that cause bloodstream infections: Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata and Candida krusei.

The T2Candida Panel and T2Dx Instrument can identify these five common yeast pathogens from a single blood sample within three to five hours — a task that can take the traditional method of blood-culture based diagnostics up to six days, and even longer to identify the specific type of yeast, the agency said.

The test breaks the yeast cells apart, releasing DNA. It then makes copies of the target DNA, and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, T2Candida will determine which species category it belongs to, helping health care providers deliver appropriate treatment, the FDA said.

Blood cultures should still be performed after using the T2Candida to confirm the tests’ results, the agency added.

Yeast bloodstream infections are fungal infections that can lead to severe complications and death if not treated quickly. People with weakened immune systems, including patients undergoing cancer treatments, receiving immunosuppressive therapy following an organ transplant, or those in intensive care units are especially susceptible, the FDA said. — Kellen Owings

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