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T2 Biosystems, Inc. (NASDAQ: TTOO) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s T2Lyme™ panel.
“We are thrilled with the FDA’s decision to grant Breakthrough Device Designation to 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 enable clinicians to ensure patients receive the correct treatment sooner and prevent the negative impact of a delay in the administration of ‘appropriate treatment and overuse of antibiotics,’ said John Sperzel. , Chairman and CEO of T2Biosystems. “This achievement follows the U.S. Patent and Trademark Office’s decision 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 operate on the FDA-cleared T2Dx® instrument and simultaneously detect bacteria that cause Lyme disease: Borrelia burgdorferi, Borrelia afzeliiand Borrelia garini. The T2Lyme panel is intended to test people with signs and symptoms of Lyme disease and to aid in the diagnosis of early Lyme disease.
Currently, there are no sensitive FDA-approved 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 to detect 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-approved diagnostics if a patient has recently been infected.
According to the US 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, the infection can spread to the joints, heart, and 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 disease in the northern hemisphere. Borrelia burgdorferi is most commonly associated with Lyme disease in North America, while Borrelia afzelii and Borrelia garini cause most Lyme infections in Europe and Asia.
The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-based combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-combination products that are subject to review as part of a premarket approval (PMA) application, premarket notification (510(k)) or a request for De Novo classification (De Novo request). This program is intended to help patients gain faster access to these medical devices by accelerating their development, evaluation and review, while preserving legal standards of PMA approval, 510(k) clearance and marketing De Novo, in accordance with FDA guidelines. protection and promotion of public health.