T2 Biosystems, Inc. announced that its T2ResistanceTM Panel, which received Breakthrough Device Designation from the Food and Drug Administration (FDA) earlier this year, is now available as a research use only (RUO) test in the United States. The T2Resistance Panel also remains on track to receive CE-Mark for commercial availability in Europe by the end of 2019.
The T2Resistance Panel RUO identifies 13 of the most serious resistance genes on the antibiotic-resistance threat list published by the Centers for Disease Control and Prevention (CDC), including genes indicating resistance to common empiric antibiotic therapies such as carbapenems, vancomycin, penicillin and more. It is the first system that can detect resistance markers directly from whole blood—in three to five hours.
The panel utilizes the same T2Dx Instrument as the T2Bacteria and T2Candida Panels – the only FDA-cleared panels that can detect sepsis-causing pathogens directly from a patient’s blood sample, without the need to wait for a blood culture. A positive blood culture takes one to five or more days before subculture and antimicrobial susceptibility testing (AST) or genomic testing can commence, which is the current pathway to identifying antibiotic resistance. Additionally, it can take four blood culture sets to detect what T2MR technology can detect in a single blood draw. In contrast, the T2Bacteria and T2Candida Panels’ sensitivity and ability to provide results faster are key advantages that enable positive changes in clinical decisions and outcomes.
Recently, T2 Biosystems was awarded a milestone-based contract of initial value of $6 million with a potential value of up to $69 million, if all contract options are exercised, from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services’ (HHS). Additionally, the Company’s T2Bacteria Panel was the first in-vitro diagnostic test to receive approval for a New Technology Add-on Payment (NTAP) by the United States Centers for Medicare & Medicaid Services (CMS).
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