T2 Biosystems Announces Submission For FDA Breakthrough Device Designation For Candida Auris Diagnostic Test
Portfolio Pulse from Benzinga Newsdesk
T2 Biosystems has submitted an application to the FDA for Breakthrough Device Designation for its Candida auris diagnostic test. The company plans to add C. auris detection to its FDA-cleared T2Candida Panel.

June 05, 2023 | 1:01 pm
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T2 Biosystems submitted an FDA application for Breakthrough Device Designation for its Candida auris test, potentially expanding its T2Candida Panel.
T2 Biosystems' submission for FDA Breakthrough Device Designation for its Candida auris diagnostic test could potentially expand its T2Candida Panel, leading to increased market share and revenue. This positive development is likely to have a short-term positive impact on the company's stock price.
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