T2 Biosystems, Inc., a provider of rapid detection of sepsis-causing pathogens and antibiotic resistance genes, 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,” says John Sperzel, chairman and CEO of T2 Biosystems. “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.
Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are proteins present in the blood when the body is responding to a specific infection. In the case of Lyme disease, antibodies can take several weeks to develop, so patients may test negative using current FDA-cleared diagnostics if a patient has been recently infected.
Lyme disease is a bacterial infection caused by the genes Borrelia and is transmitted to humans through the bite of infected ticks. It is considered the most common vector borne illness in the United States. Borrelia burgdorferi is spread by deer ticks (Ixodes scapularis) in the northeastern, mid-Atlantic and north-central regions of the U.S., and by the western blacklegged tick (Ixodes pacificus) on the Pacific Coast. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans may get Lyme disease each year in the United States. Typical symptoms include fever, headache, fatigue, and skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system.
