In a recent release, T2 Biosystems and CARB-X, a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria, announced that the T2Resistance Panel is the first diagnostic to graduate from CARB-X’s portfolio. The graduation marks an important milestone on the path toward approval for use on patients in hospitals in the U.S., Europe, and elsewhere around the globe.
In 2017, CARB-X awarded T2 Biosystems $2.0 million to support the development of the T2Resistance Panel, designed to detect 13 resistance genes from both gram-positive and gram-negative pathogens directly from a whole-blood specimen, without the need to wait for blood cultures. The panel was granted Breakthrough Device designation by the Food and Drug Administration (FDA) earlier this year and is expected to be available for research use only (RUO) in the U.S. by the end of Q3 2019 and receive CE-Mark for commercial availability in Europe by the end of 2019.
“Addressing the global superbug crisis requires urgent development of innovative diagnostics, like T2’s technology, as well as new drugs and vaccines. This is the first diagnostic to graduate from CARB-X’s portfolio, and we are excited that we could help T2 with funding and support to develop this technology,” said Kevin Outterson, Executive Director of CARB-X, which is based at the Boston University School of Law. “The T2Resistance Panel will provide healthcare professionals with a new rapid test, a first of its kind, to provide timely and accurate detection of drug-resistant infections and inform treatment decisions to ensure patients are given the most appropriate care.”
“We are incredibly grateful to CARB-X for the funding and support they provided to our team in the development of the T2Resistance Panel over the past year and a half,” said John McDonough, chairman and chief executive officer of T2 Biosystems. “Rapid identification of the genes and species associated with antibiotic resistance can help enable the reduction of unnecessary antibiotic use, which is the primary cause of resistance. Being the first diagnostic to graduate from CARB-X’s portfolio is a significant milestone in the development of technology that has such capabilities.”
The T2Resistance Panel identifies 13 of the most serious superbugs and 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.