T2 Biosystems (TTOO) Seeks FDA Breakthrough Device Designation for Candida Auris Test Amid Growing Global Health Concerns

T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic-resistance genes, has recently submitted an application to the U.S. 

Food and Drug Administration (FDA) for Breakthrough Device Designation for its Candida auris test. This move comes as the company aims to address the urgent global health threat posed by Candida auris (C. auris), a multidrug-resistant fungal pathogen with a high mortality rate. 

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The potential acceleration of FDA clearance and commercialization for T2 Biosystems’ C. auris diagnostic test could position the company as a crucial player in the fight against this deadly infection.

Candida Auris: A Global Health Threat:

Candida auris has been labeled as a serious global health threat by both the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). 

With a mortality rate of up to 60%, this multidrug-resistant fungal pathogen has proven challenging to identify using standard laboratory methods. Some strains of C. auris are resistant to all available classes of antifungals, and it easily spreads within healthcare facilities, leading to severe infections with high death rates. 

The economic burden of fungal diseases in the United States alone is estimated to be as high as $48 billion annually. Early detection and proper treatment of C. auris infections are critical to mitigating its impact on public health.

Breakthrough Device Designation Application:

T2 Biosystems’ application for Breakthrough Device Designation highlights the potential of its novel direct-from-blood C. auris diagnostic test to improve patient outcomes. If granted, this designation would expedite the path toward FDA clearance and commercialization. 

The company’s existing T2Candida Panel, the only FDA-cleared diagnostic capable of detecting sepsis-causing fungal pathogens directly from whole blood in just 3-5 hours, has already proven its value. 

Adding C. auris to this panel would provide clinicians with rapid results, enabling targeted antimicrobial treatment, aligning with the CDC’s call to action.

Investment Considerations:

T2 Biosystems’ pursuit of Breakthrough Device Designation for its Candida auris test signifies an important development that could impact its future prospects. However, retail investors must consider several factors before making any investment decisions.

Regulatory Landscape: 

The successful acquisition of Breakthrough Device Designation would demonstrate the FDA’s recognition of T2 Biosystems’ innovation. 

This designation could help expedite the path to market for the Candida auris test, generating positive investor sentiment and potentially attracting interest from healthcare institutions and providers.

Competitive Landscape: 

T2 Biosystems faces competition from other companies developing rapid diagnostic technologies for sepsis and fungal infections. Investors should carefully assess the company’s competitive positioning, including its ability to differentiate its products and maintain a favorable market share.

Financial Performance: 

T2 Biosystems’ financial data reveals significant operating losses and a decline in stock price. Retail investors should evaluate the company’s financial stability, growth prospects, and ability to execute its business strategy.

Market Potential: 

The global health threat posed by C. auris presents a significant market opportunity for T2 Biosystems. The ability to detect and combat this deadly pathogen could position the company favorably in the healthcare industry, potentially attracting collaborations, partnerships, and market adoption.


In conclusion, T2 Biosystems’ application for FDA Breakthrough Device Designation for its Candida auris test marks a critical milestone in the company’s efforts to combat the global health threat posed by this multidrug-resistant fungal pathogen. 

With a high mortality rate and limited detection methods, the urgent need for rapid and accurate diagnosis of Candida auris infections cannot be understated. 

If granted, the designation would not only expedite FDA clearance and commercialization but also position T2 Biosystems as a key player in the fight against this deadly infection. However, investors must carefully evaluate the regulatory and competitive landscape, as well as the company’s financial performance, to make informed investment decisions. 

Nonetheless, the potential market opportunity and the company’s commitment to addressing this critical health concern are factors that may attract attention from investors and healthcare institutions alike. 

As T2 Biosystems continues its journey, monitoring its progress and market positioning will be crucial.


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