T2 Biosystems Submits Breakthrough Device Designation Application to FDA

T2 Biosystems (Nasdaq: TTOO) has submitted an application to the FDA for Breakthrough Device Designation for a Candida auris (C. auris) test. The Company recently announced plans to add C. auris detection to its FDA-cleared T2Candida® Panel.


The company’s T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from whole blood, without the need to wait days for a positive blood culture.

Rapid detection of these pathogens is essential to getting infected patients on appropriate antimicrobial therapy and improving clinical outcomes.

The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

C, auris is a multidrug-resistant fungal pathogen with a mortality rate of up to 60%. It has been labeled a serious global health threat by the CDC and the World Health Organization.

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians quickly and effectively treat patients. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers.

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T2 Biosystems Submits Breakthrough Device Designation Application to FDA

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