The FDA has granted T2 Biosystems, Inc. “Breakthrough Device” designation for the T2Resistance Panel, a new 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,” said Sandy Estrada, PharmD, vice president, medical affairs at T2 Biosystems and president of Florida Health-System Pharmacists (FSHP) organization. “These conventional methods, including blood cultures and antimicrobial susceptibility testing (AST), take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need.”
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 days 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.
