The T2Resistance™ Panel detects gram-negative and gram-positive resistance genes direct from whole blood in 3 to 5 hours on the T2Dx instrument because there is no need to wait for a blood culture. It is expected to be available for research use only (RUO) in the U.S. and CE marked by the end of 2019.
Rapid detection of resistance markers: The T2Resistance Panel detects 13 resistance genes from both gram-positive and gram-negative pathogens. These include detection of the most clinically important carbapenem resistance genes (KPC, OXA-48, NDM, VIM, IMP), which are listed on the CDC Urgent Threat list for antibiotic resistance; detection of CTXM-14 and CTXM-15, a major source of extended spectrum beta lactamases (ESBLs); detection of the AmpC beta-lactamase genes (CMY, DHA); detection of vanA/B resistance genes, which are responsible for vancomycin resistant gram-positive enterococcus; and the detection of the methicillin resistance genes mecC and mecA, which cause methicillin resistant Staphylococcus aureus (MRSA). The Panel utilizes the same T2Dx® Instrument as the T2Bacteria® and T2Candida® Panels – the first and only FDA-cleared panels for detection of sepsis-causing bloodstream infections direct from a patient’s blood sample, with no need to wait for a blood culture – the only FDA cleared products that eliminates waiting for a blood culture.
The growing threat of resistant bloodstream infections: Antibiotic resistance is recognized by the WHO as ‘one of the biggest threats to global health, food security, and development today’. Current diagnostics are ill-equipped to deal with this threat as they require a positive blood culture–which takes 1 to 5 or more days–before subculture and antimicrobial susceptibility testing (AST) or genomic testing can be performed. Additionally, it can take 4 blood culture sets to detect what T2MR can detect in a single blood draw.
Accelerated identification to combat antibiotic resistance: Direct-from-blood rapid diagnostics have the potential to prevent the spread of multidrug-resistant organisms and improve patient outcomes by enabling rapid identification of the genes and species associated with antibiotic resistance – enabling the reduction of unnecessary antibiotic use which is the primary cause of resistance. Most importantly, these tests can enable more patients to get on the right targeted therapy quicker, potentially reducing mortality and hospitalization cost. Finally, these tests could also be used to accelerate clinical trials for new antibiotics and reduce the time to commercial availability.
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