Exhibit 99.1
MEDIA RELEASE
T2 Biosystems Announces Granting ofCE-Mark for T2Resistance™ Panel
The T2Resistance Panel is the only direct-from-blood diagnostic designed to detect genetic markers
associated with antibiotic-resistant bloodstream infections
LEXINGTON, Mass., November 20, 2019 (GLOBE NEWSWIRE)—T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, andCARB-X, a globalnon-profit partnership dedicated to accelerating R&D innovation to address the rising global threat of drug-resistant bacteria, today announced the granting of aCE-Mark to the T2Resistance™ Panel. WithCE-mark, T2 Biosystems has met the requirements of theIn-Vitro Diagnostics Directive (98/79/EC) and can market the T2Resistance Panel within the European Economic Area (EEA).
The panel, which was developed with support fromCARB-X, was the first diagnostic tograduate fromCARB-X’s portfolio and is now the firstCARB-X-powered product to be approved for use in human whole blood specimens from patients. The T2Resistance Panel 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 diagnostic test that can detect all of these resistance markers directly from whole blood—in three to five hours.
“Fighting antimicrobial resistance not only requires the development of rapid diagnostics, like the T2Resistance Panel, but also requires access to these innovations so they can make a positive impact on as many patients as possible,” said John McDonough, chairman and chief executive officer of T2 Biosystems. “We are grateful that with the invaluable help ofCARB-X’s funding, patients in Europe can start benefitting clinically from the early detection of antibiotic-resistant bloodstream infections.”
To receiveCARB-X funding, T2 Biosystems had to demonstrate to an advisory panel consisting of global experts in the antimicrobial resistance (AMR) and diagnostic fields that the innovation had the potential to significantly accelerate and improve the detection and diagnosis of serious drug-resistant bacterial infections, and to contribute to the global fight against drug-resistant bacteria.
“We’re proud that we were able to help T2 deliver its technology to market as part of our effort to support the development of rapid diagnostics, antibiotics, vaccines and other products from around the world to address drug-resistant bacteria,” said Kevin Outterson, Executive Director ofCARB-X, which is based at the Boston University School of Law. “This represents a huge step forward for patients, and a critical milestone forCARB-X. Rapid diagnosis of drug-resistant infections is essential to improve appropriate treatment for patients, and to save lives.”CARB-X is a consortium led by Boston University and funded by a global partnership.
Drug-resistant infections are responsible for an estimated 700,000 deaths worldwide each year, according to the World Health Organization (WHO). Existing diagnostics to detect antibiotic resistance markers primarily rely on blood cultures, which can take days, and do not provide results when patients need them most. As a result, physicians are often unable to treat infections quickly with the appropriate antibiotics, leading to poor patient outcomes, higher mortality, and the overuse of antibiotics empirically.