T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Company’s T2Lyme™ Panel.
“We are pleased with the FDA’s decision to grant Breakthrough Device Designation for the T2Lyme Panel, as it brings us one step closer to providing clinicians with a valuable tool to detect Lyme disease earlier. Similar to the value proposition of our sepsis panels, we believe the T2Lyme Panel will allow clinicians to ensure patients receive the appropriate therapy faster, and prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics,” stated John Sperzel, Chairman and CEO of T2Biosystems. “This achievement follows the decision by the U.S. Patent and Trademark Office to grant T2 Biosystems a patent covering the T2Lyme Panel, ‘NMR Methods and Systems for the Rapid Detection of Tick-Borne Pathogens’ and we look forward to further advancements with our T2Lyme Panel.
The T2Lyme Panel is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2Dx® Instrument and simultaneously detect the bacteria that cause Lyme disease: Borrelia burgdorferi, Borrelia afzelii, and Borrelia garinii. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease.
Currently, there are no sensitive FDA-cleared diagnostic tests for the detection of early Lyme disease. Laboratory diagnosis of Lyme disease has traditionally used a two-tier process of enzyme immunoassay and western blot for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are specific proteins produced by the body in response to an 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.
According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year. 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.
Lyme disease is a bacterial infection caused by Borrelia pathogens and is transmitted to humans through the bite of infected ticks. It is considered the most common vector borne illness in the Northern Hemisphere. Borrelia burgdorferi is most commonly associated with Lyme disease in North America, while Borrelia afzelii and Borrelia garinii cause most Lyme infections in Europe and Asia.
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.