FDA Grants T2 biosystems breakthrough device designation for the T2Resistance™ Panel; expected availability through CE mark in 2019

New, expanded panel detects gram-negative and gram-positive resistance genes to help combat antimicrobial resistant bloodstream infections

The FDA has granted T2 Biosystems, “Breakthrough Device” designation for the T2Resistance Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture.

The 13 genes identified on the panel include the most clinically important, as they are largely resistant to antimicrobial drugs that for certain patients, are crucial in the treatment of bacterial infections, including carbapenems, vancomycin, penicillin and more. Several of the genes detected by the panel are listed on the CDC’s Urgent Threat list for antibiotic resistance.

The Breakthrough Designation allows T2 Biosystems to work closely with the FDA during the premarket review phase to ensure patients can have access to the benefits of this innovation as soon as possible.

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. These conventional methods, including blood cultures and antimicrobial susceptibility testing (AST), take 3 or more to provide an actionable result. This doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need,” said Sandy Estrada, PharmD, vice president, medical affairs at T2 Biosystems and president of Florida Health-System Pharmacists (FSHP) organization.

The T2Resistance™ Panel—which is expected to be available for research use only (RUO) in the U.S. and receive CE Mark for commercial availability in Europe later this year— can provide results in 3 to 5 hours, directly from a blood sample. This technology does not require a positive blood culture, thus eliminating from the diagnostic process and therefore expediting accurate, targeted treatment for certain antibiotic resistant bloodstream infections. As a result, the panel, similar to the T2Bacteria and T2Candida panels, can help combat the consequences associated with overprescribing unnecessary antimicrobial drugs, allowing clinicians to potentially save more patient lives, cut hospitalization costs and reduce the unnecessary use of antimicrobial drugs—the primary cause of resistance.

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,” said John McDonough, president and chief executive officer of T2 Biosystems. “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 utilizes the same T2Dx® Instrument as the T2Bacteria® and T2Candida® Panels – the first and only FDA-cleared panels for direct detection of sepsis-causing pathogens from whole blood samples, which enable clinicians to start swift, targeted treatment for their patients. T2Resistance™ panel has been developed with the help of an award from CARB-X, funded by the Biomedical Advanced Research and Development Authority (BARDA), a government agency at the U.S. Department of Health and Human Services; the Wellcome Trust, a global charitable foundation based in the U.K.; with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). T2 Biosystems owns exclusive worldwide distribution and intellectual property rights to the T2Resistance™ Panel.