T2 Biosystems (NASDAQ:TTOO) stock is rising higher on Tuesday after the company revealed its submission for a Breakthrough Device designation for its Candida auris test.
The company has submitted its application for its Candida auris test to the Food and Drug Administration (FDA). It’s seeking Breakthrough Device designation as it plans to add the test to its FDA-cleared T2Candida Panel.
Candida auris is of major concern to those in the healthcare field as it has a mortality rate of up to 60%. This has prompted the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to declare it a serious global health threat.
Candida auris is a multidrug-resistant fungal pathogen. Considering its mortality rate, T2 Biosystems believes adding it to its T2Candida Panel would be a major boon to healthcare workers. That’s due to its ability to identify five variants of Candida species without having to wait days for a positive blood culture.
How This Affects TTOO Stock
Investors are excited about the prospect of the FDA granting T2 Biosystems Breakthrough Device designation for the Candida auris test. If it does, it could act as a major catalyst sending shares of TTO stock higher.
Traders are already seeing heavy trading for TTOO stock today on the submission announcement. This has more than 44 million shares of the stock changing hands as of this writing. That’s a massive surge compared to its daily average trading volume of about 10 million shares.
TTOO stock is up 17.1% as of Tuesday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
