T2 Biosystems, Inc. announced that it has signed a non-binding letter of intent to enter into a strategic partnership with ECO Laboratory. Together, the company plan to launch the T2Lyme Panel as a Laboratory Developed Test (LDT), for the detection or early Lyme disease, and build the premier Lyme testing laboratory in the United States. The T2Lyme Panel is a direct-from-blood molecular diagnostic test designed for the early detection of Borrelia burgdorferi, the bacterium that causes Lyme disease in the United States.

Lyme disease is the leading vector-borne disease in America, with an estimated 3.4 million tests performed each year. The current diagnostic process is a two-tiered antibody test algorithm that relies on the presence of antibodies and can only be used accurately four to eight weeks after infection. If left untreated, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively.

Although early symptoms of Lyme disease are similar to the flu, Borrelia burgdorferi infections can lead to chronic, debilitating disease. To address this critical unmet need, the company has developed a highly sensitive diagnostic test for the detection of early Lyme disease, with an analytical sensitivity that is in line with the company's FDA-cleared sepsis tests. The company believe the company's test will detect Lyme disease within the first 30 days after infection, compared to antibody tests that can take 30-60 days after infection.

The company is finalizing internal validation and verification, and the company expects to be in position for a product launch during the third quarter of 2024. The Company expects to announce details regarding the strategic partnership with ECO Laborator when the definitive agreement has been executed.