FDA Grants Breakthrough Device Designation for the T2Resistance Panel

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the T2Resistance Panel, a diagnostic tool that detects resistance markers from a single patient blood sample.

Developed by T2 Biosystems, Inc., the device eliminates the need to wait the standard 1 to 5 days for a positive blood culture before conducting antimicrobial susceptibility testing. The T2Resistance Panel can detect 13 resistance genes from gram-positive and gram-negative pathogens and provide results in as little as 3 to 5 hours from a single blood sample, allowing clinicians to provide faster and more targeted treatment, and avoid overprescribing drugs that are contributing to antimicrobial resistance.

“Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient,” Sandy Estrada, PharmD, vice president of medical affairs at T2 Biosystems and president of Florida Health-System Pharmacists organization, said in a statement.

“These conventional methods, including blood cultures and antimicrobial susceptibility testing, take 3 or more days to provide an actionable result,” Dr. Estrada continued. “This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need.”

The FDA designation means T2 Biosystems, Inc. will coordinate with the FDA during the premarket review phase.

The product is expected to be available for research use only in the US and to receive CE Mark for commercial availability in Europe later this year, according to the company statement.

“We’re grateful to the FDA for bringing us one step closer to getting the T2Resistance Panel in the hands of clinicians across the country,” John McDonough, president and chief executive officer of T2 Biosystems, said in a statement. “With the introduction of this panel, the T2 product portfolio will continue to expand to enable clinicians to make fast, accurate treatment decisions for the more than 2 million people who get an antibiotic-resistant infection each year in the United States alone.”

The T2Resistance Panel was supported in part via an award from CARB-X and funded by the Biomedical Advanced Research and Development Authority, a government agency at the US Department of Health and Human Services; the Wellcome Trust, a global charitable foundation based in the UK; and also received in-kind support from National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

Last year, the FDA provided marketing clearance for the T2Bacterial Panel, a device capable of detecting specific sepsis-causing bacterial pathogens directly from a whole blood specimen in around 5 hours.