FDA Grants Breakthrough Device Designation for the T2Resistance Panel

This is important for our readers who practice in the ICU.

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

The 13 genes identified with 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.

“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 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,” said Sandy Estrada, PharmD, the vice president of medical affairs at T2 Biosystems and president of the Florida Society of Health-System Pharmacists.

The T2Resistance panel—which is expected to be available for research use only in the United States and receive CE Marking for commercial availability in Europe later this year—can provide results in three to five 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 T2 Biosystems 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.

The T2Resistance panel uses 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.

Several of the genes detected by the panel are listed on the CDC’s Urgent Threat list for antibiotic resistance.