T2 Biosystems Receives FDA Breakthrough Device Designation for Diagnostic Test

T2 Biosystems (Nasdaq: TTOO) has been granted Breakthrough Device designation for its Candida auris (C. auris) direct-from-blood molecular diagnostic test by the FDA. This is the company’s third product to receive this designation, having previously been granted FDA Breakthrough Device designation for its T2Resistance® Panel and T2Lyme™ Panel.

John Sperzel, Chairman and CEO of T2 Biosystems, said, “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.”

Highlights

C.auris is a difficult to identify, multidrug-resistant fungal pathogen and serious global health threat with a mortality rate of up to 60%.

The company’s diagnostic test is designed to detect C. auris species directly from blood in just 3-5 hours, without the need to wait days for a positive blood culture.

The FDA Breakthrough Devices Program is a voluntary program for certain medical products that provide for more effective treatment or diagnosis of life-threatening or debilitating diseases.

This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, consistent with the FDA’s mission to protect and promote public health.

T2 currently markets and sells the T2Candida® Panel, the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from blood, without the need to wait days for a positive blood culture.

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 Receives FDA Breakthrough Device Designation for Diagnostic Test

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