FDA Clears Rapid Blood Test for Sepsis-Causing Pathogens

Megan Brooks

Disclosures

September 23, 2014

The US Food and Drug Administration (FDA) has cleared for marketing the first direct blood test capable of rapidly detecting 5 Candida species that cause bloodstream infections that often lead to sepsis.

The T2Candida Panel and T2Dx Instrument (T2Candida, T2 Biosystems) detects Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata, and/or Candida krusei.

These yeast pathogens may cause serious bloodstream infections in people with weakened immune systems, such as those undergoing cancer treatment, those receiving immunosuppressive therapy after organ transplantation, or critically ill patients in the intensive care unit, according to an FDA release.

Traditional methods of detecting yeast pathogens in the bloodstream may take up to 6 days, and it may take even longer to identify the specific type of yeast present. T2Candida can identify these 5 common yeast pathogens from a single blood specimen within 3 to 5 hours, the FDA notes.

"By testing one blood sample for five yeast pathogens — and getting results within a few hours — physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections," Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in an FDA news release.

"T2Candida and T2Dx have the potential to quickly change the hospital care paradigm and improve outcomes by offering a new and effective screening option for patients who are at-risk or suspected of having sepsis," Eleftherios Mylonakis, MD, PhD, chief, Division of Infectious Diseases, Rhode Island Hospital and The Miriam Hospital, Providence, Rhode Island, said in a T2 Biosystems news release.

The FDA reviewed T2Candida through its de novo classification process, a regulatory pathway for certain novel low- to moderate-risk medical devices.

In a study of 1500 patients, T2Candida correctly categorized nearly 100% of negative specimens as negative for the presence of yeast, the FDA says. In a separate study of 300 blood samples with specific concentrations of yeast, T2Candida correctly identified the organism in 84% to 96% of positive specimens.

"Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results," the FDA notes in the release.

According to the company release, studies have shown that if Candida can be diagnosed and properly treated within 12 hours of the presentation of symptoms, the associated mortality can be reduced from about 40% to 11%.

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