T2 Plans to Commercialize Diagnostic Test for Early Lyme Disease

 T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today plans to complete development of, and commercialize, a diagnostic test for the detection of early Lyme disease, with the goal of initiating marketing and sales in the United States as a Laboratory Developed Test (LDT) in 2023.

“We believe there is a significant market opportunity for a sensitive diagnostic test to detect early Lyme disease, and initial performance data on the T2Lyme Panel is very encouraging. Our decision to advance toward commercialization in 2023 follows two recent achievements: the receipt of a patent from the U.S. Patent and Trademark Office and the receipt of FDA Breakthrough Device Designation, both covering the T2Lyme Panel,” stated John Sperzel, Chairman and CEO of T2Biosystems. “While we plan to commence marketing and sales as an LDT in 2023, we intend to subsequently initiate a U.S clinical trial for the purpose of pursuing FDA clearance of the T2Lyme Panel. We believe the T2Lyme Panel will potentially allow clinicians to ensure patients receive appropriate therapy faster, and prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics.”

The T2Lyme™ Panel is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2Dx® Instrument and to detect Borrelia burgdorferi, the bacteria that causes Lyme disease. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease.

https://finance.yahoo.com/news/t2-biosystems-announces-plan-commercialize-130000550.html