T2 Gets FDA Breakthrough Device Status for Diagnostic Test

Dow Jones2023-07-20

By Ben Glickman

T2 Biosystems said Thursday its Candida auris diagnostic test had received Breakthrough Device Designation from the U.S. Food and Drug Administration.

The Lexington, Mass.-based health diagnostics company said the test, a direct-from-blood molecular diagnostic test meant to detect the fungal pathogen Candida auris, was its third to receive FDA Breakthrough Device Designation. The T2Resistance Panel and T2Lyme Panel, meant to detect Lyme disease, have also received the designation.

The status from the FDA helps speed up the development and approval of devices that allow for the more effective treatment or detection of life-threatening or debilitating conditions.

Candida auris is resistant to multiple drugs and can have a mortality rate of up to 60%, the company said.

Shares rose 21% to 12 cents in pre-market trading.

Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

July 20, 2023 08:47 ET (12:47 GMT)

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Comments

  • Kennoobie
    2023-07-20
    Kennoobie
    See it rise till 0.25 tonight
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