T2 Biosystems today announced it won FDA clearance for its T2 Bacteria panel for detecting bacterial species in human blood from patients with suspected bloodstream infections, and announced plans for an upcoming offering.
The Lexington, Mass.-based company said that it won approval for the detection of specific sepsis-causing bacterial pathogens as acquired from a whole blood specimen.
The system takes five hours to analyze whole blood specimens, the company said, which is more than two and a half days faster than most blood-culture dependent tests, as indicated from over 1,400 pivotal trials conducted in the US, T2 said.
“The T2Bacteria Panel’s rapid results and high sensitivity make it a valuable tool for the diagnosis and management of suspected bloodstream infections. This is an important breakthrough as bacterial infections are a major cause of poor patient outcomes and high hospital costs. This is a game-changer,” Dr. W. Peacock of the Baylor College of Medicine said in a prepared statement.
T2 Biosystems said that all other FDA-cleared diagnostic tests designed to detect bacteria in blood require a positive blood culture sample prior to bacterial species identification, which can delay results by up to five days.
“The FDA’s market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections. This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality,” prez & CEO John McDonough said in prepared remarks.
The company also said that it is launching an underwritten registered public offering of approximately 5.7 million shares of its common stock, with a 30-day underwriter’s option to purchase an additional 847,500 shares of its common stock.
At its closing price of $8.06 yesterday, the offering would be worth approximately $45.5 million. Leerink Partners is acting as the joint book-running manager for the offering, with Cannacord Genuity acting as the passive book-running manager, according to a press release.
In March, T2 Biosystems released results from four studies of its T2Dx blood diagnostics system designed to detect pathogens that cause sepsis, touting clinical and performance advantages when compared to traditional blood cultures.
