What's Going On With T2 Biosystems Shares Today?

T2 Biosystems Inc TTOO shares are trading higher Thursday after the FDA granted Breakthrough Device designation for the company's Candida auris direct-from-blood molecular diagnostic test.

What To Know: T2 said it plans to add the Candida auris diagnostic test to its FDA-cleared T2Dx instrument, expanding capabilities. The test uses blood to make detections in three to five hours. 

"We are pleased with the FDA's decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance," said John Sperzel, chairman and CEO of T2 Biosystems.

"We believe adding Candida auris to the test menu on our FDA-cleared T2Dx Instrument will provide clinicians with a valuable tool to rapidly detect a dangerous, multidrug-resistant fungal pathogen much faster than blood culture-based methods, strengthening our value proposition and increasing the attractiveness of our products to U.S. hospitals."

The diagnostic test is T2's third product to receive FDA Breakthrough Device designation.

See Also: Why Vir Biotechnology Stock Is Plunging Today?

TTOO Price Action: T2 shares were up 29.3% at 13 cents at the time of publication, according to Benzinga Pro.

Photo: Lorenzo Cafaro from Pixabay.