NEW YORK (360Dx) – T2 Biosystems announced today that it has received market clearance from the US Food and Drug Administration for its T2Bacteria Panel.
The T2Bacteria panel detects species of bacteria in whole blood samples from patients with potential bloodstream infections in roughly five hours.
The firm's panel runs on the firm's FDA-cleared T2Dx instrument and identifies five of the most common and deadly sepsis-causing species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
"The FDA's market clearance of the T2Bacteria panel is a significant milestone for our company," T2 Biosystems CEO and President John McDonough said in a statement. "[The] technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality."
T2 Biosystems previously received market clearance for its T2Candida panel and has concluded preclinical work on its T2Lyme panel, both of which run on the T2Dx instrument. The firm plans to start an FDA clinical trial using the T2Lyme test later this year.
T2 Biosystems also recently was awarded a $2 million grant from CARB-X in order to expedite the development of a new test to detect bacterial pathogens and resistance markers.
Shares of T2 were down 8 percent at $8.13 in Tuesday afternoon trade on the Nasdaq, despite the FDA clearance. Leerink analyst Puneet Souda noted that the firm's shares had risen recently in anticipation of the approval, so he wasn't surprised by Tuesday's decline.