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T2 Biosystems Gets CE Mark for Direct-From-Blood Antimicrobial Resistance Panel

NEW YORK – T2 Biosystems said on Wednesday that it has received the CE-IVD mark for its T2Resistance Panel to detect genetic signatures of drug-resistant bacteria.

The T2Resistance Panel identifies 13 resistance genes that can confer resistance to typical empiric antibiotics, like carbapenems, vancomycin, and penicillin, directly from whole blood in three to five hours using the firm's T2Dx instrument. The panel was also been granted breakthrough device designation by the US Food and Drug Administration earlier this year.

Development of the panel was supported in part by a $2 million grant from CARB-X, a global non-profit led by Boston University and funded by a global partnership that includes the US Biomedical Advanced Research and Development Authority (BARDA).

"This represents a huge step forward for patients, and a critical milestone for CARB-X," said Kevin Outterson, executive director of CARB-X.

BARDA Director Rick Bright commented that reaching this milestone "demonstrates how essential public-private partnerships like CARB-X are in the global fight against antimicrobial resistant infections."

In founding CARB-X, BARDA and its partners "sought to stimulate a more robust pipeline for the innovative products needed to help save lives from some of the toughest infections ever known," Bright said, adding that BARDA continues to work with T2 on developing their diagnostics "to expand the platform's potential use in rapidly identifying a variety of biodefense-related infections to protect health security."

T2 was recently awarded funding from BARDA worth up to $69 million. Its resistance panel was also the first to obtain a New Technology Add-on Payment (NTAP) from the US Centers for Medicare & Medicaid Services.