T2 Biosystems Receives FDA Clearance to Market T2Candida Panel for Pediatric Patients Page 1

Expands available market to over 200 children’s hospitals in the United States

LEXINGTON, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida Panel for pediatric patients. The Company expects to immediately begin marketing and selling the T2Candida Panel under the expanded pediatric claim.

The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood, in just 3-5 hours, without having to wait days for a positive blood culture. The T2Candida Panel runs on the FDA-cleared T2Dx Instrument and simultaneously detects five Candida species including, Candida albicans, Candida tropical, Candida parapsilosis, Candida frizzAnd Candida glabrataAccording to the U.S. Centers for Disease Control and Prevention (CDC), the five species detected by the T2Candida Panel account for a whopping 95% of all Candida bloodstream infections in the US

“This FDA clearance marks another important milestone in our commitment to expanding the clinical utility of our sepsis test panels and enables our commercial team to immediately begin marketing and selling our test to more than 200 children’s hospitals in the U.S.,” said John Sperzel, chairman and CEO of T2 Biosystems. “Studies show that the T2Candida panel Candida species significantly faster and with greater sensitivity, compared to blood culture-based diagnostics, and we believe the new claim for pediatric testing will enable clinicians to improve outcomes and reduce costs by achieving faster, targeted antifungal treatment for their pediatric patients.”

According to the Journal of Fungia peer-reviewed scientific journal that provides an advanced forum for studies related to pathogenic fungi, Candida species are a significant contributor to morbidity and mortality in hospitalized children. In addition, children with invasive candidiasis place a significant burden on the U.S. health care system, with an average increased hospital stay of 21 days and approximately $92,000 in additional hospital charges.