T2 Biosystems Submits for Revolutionary Candida Auris Diagnostic Test for FDA Breakthrough Device Designation

T2 Biosystems, Inc., a pioneer in the field of rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that they have submitted an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for their Candida auris test. With plans to add the C. auris detection to their existing FDA-cleared T2Candida® Panel, the Company is working hard to further improve and perfect their testing capabilities to ensure reliable results and improved patient outcomes.

The global health threat posed by the Candida auris (C. auris) fungal pathogen has caused alarm, with the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) issuing an urgent warning. It is estimated that C. auris can cause mortalities of up to 60%, and its deadly nature is further compounded by its resistance to three commonly used antifungal drugs.

Moreover, it can be hard to identify in laboratory tests, and has the capacity to spread quickly in healthcare faculties. With U.S. fungal diseases costing up to $48 billion annually, public health professionals are advocating for awareness to be raised in order to reduce the detrimental burden caused by this rapidly evolving threat. Early detection and effective treatment could be lifesaving.

T2 Biosystems is pursuing FDA Breakthrough Device Designation for their new direct-from-blood Candida auris diagnostic test. This could potentially speed up the process of FDA clearance and commercialization.

Their T2Candida Panel is the only FDA-cleared diagnostic able to detect sepsis-causing fungal pathogens directly-from-blood, in only 3-5 hours, without the need to wait for blood culture results. Adding C. auris to the T2Candida Panel could rapidly provide clinicians with targeted antimicrobial treatment results, affirming CDC’s call to action.

The T2Candida Panel, FDA-cleared and a breakthrough utilization of whole blood samples, is revolutionizing sepsis diagnosis. This test transported directly to hospital laboratories, eliminates the wait time for slower-confirming positive blood cultures and runs on the fully automated T2Dx® Instrument.

Its beneficial speed has detected dire pathogens like Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, Candida glabrata, and even Candida auris. With T2Candida, doctors can diagnose infection quickly and prescribe proper antimicrobial therapies for their patients, potentially aiding in their improved recovery.

The FDA’s Breakthrough Devices Program enables accelerated development, assessment, and review of medical devices and device-led combination products addressing some of the most devastating and debilitating diseases and conditions.

By streamlining the PMA, 510(k), and De Novo classification processes, this program empowers patients to access the tools they need almost immediately, while still maintaining the strict statutory standards set by the FDA to protect and promote public health.

About T2 Biosystems

T2 Biosystems is changing the way clinicians treat patients and reduce costs with their proprietary T2 Magnetic Resonance (T2MR®) technology. Their products, like the T2Dx® Instrument, T2Bacteria® Panel, T2Candida® Panel, T2Resistance® Panel, and more, are designed to provide fast and reliable detection of sepsis-causing pathogens and antibiotic resistance genes.

They have an extensive pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, allowing them to continue to innovate and revolutionize clinical care. With T2 Biosystems, clinicians can quickly and confidently diagnose and treat patients more effectively than ever before.

Forward-Looking Statements

The possibilities of our Breakthrough Device application being successful are exciting, as it may accelerate the FDA clearance of our T2Cauris Panel and our commercialization of this innovative device. Already, early data predicts that the T2Cauris Panel will successfully detect C. auris, which will undoubtedly bring numerous benefits to our customers. However, there are still a number of risks that may prevent us from realizing all of our desired outcomes. That said, we remain confident and look forward to our continued progress in bringing this innovative product to market.

Leave a Comment