T2 Biosystems Announces Issuance of U.S. Patent for Direct Detection of Lyme Disease

Rhea-AI Summary

T2 Biosystems (NASDAQ:TTOO) has received U.S. Patent 11,326,213 for its T2Lyme™ Panel, which enables rapid detection of Lyme disease-causing bacteria from blood samples in just 3 to 5 hours. This innovation addresses a critical need as current FDA-cleared tests are inadequate for early detection, often leading to delayed treatment. Approximately 476,000 people are treated for Lyme disease annually in the U.S., highlighting the market potential for fast and accurate diagnostics. T2's patent portfolio now includes 46 U.S. patents, reinforcing its commitment to advancing healthcare diagnostics.

Positive

• U.S. Patent 11,326,213 granted for T2Lyme™ Panel enhances rapid Lyme disease diagnosis.
• T2Lyme™ Panel can identify pathogens from blood in 3 to 5 hours, significantly faster than traditional methods.
• Strengthens T2 Biosystems' patent portfolio to 46 U.S. patents, indicating robust innovation.
• Addresses critical healthcare need with no existing FDA-cleared options for early Lyme detection.

Negative

• None.

LEXINGTON, Mass., May 20, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Patent and Trademark Office has issued patent number 11,326,213 (the ‘213 Patent), “NMR Methods and Systems for the Rapid Detection of Tick-Borne Pathogens”. The ‘213 Patent covers the T2Lyme™ Panel, which identifies the bacteria that cause Lyme disease directly from a patient’s blood in 3 to 5 hours. The T2Lyme Panel runs on the T2Dx Instrument^®, the same instrument currently used to run the FDA-cleared T2Bacteria^® and T2Candida^® Panels.

Lyme disease is a debilitating disease caused by the bacteria Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. 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. Each year, approximately 30,000 cases of Lyme disease are reported to the Centers for Disease Control (“CDC”) by state health departments and the District of Columbia, however, recent estimates suggest that approximately 476,000 people are treated for Lyme disease each year in the United States.

Currently, there are no FDA-cleared diagnostic tests for the sensitive detection 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.

“The ’213 Patent, combined with our existing patent portfolio of 46 U.S. patents and 16 U.S. patent applications, as well as 73 international patents and patent applications, demonstrates the strength of our technology to identify a range of pathogens directly from whole blood in 3 to 5 hours, which allows clinicians to ensure patients receive the appropriate therapy faster, and prevents the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “This U.S. patent further demonstrates our commitment to advance the development and commercialization of innovative diagnostic products for critical unmet needs in healthcare.”

About T2 Biosystems:

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx^® Instrument, the T2Bacteria^® Panel, the T2Candida^® Panel, the T2Resistance^® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR^®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers.

Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406

FAQ

What is the significance of the U.S. Patent 11,326,213 for T2 Biosystems?

The patent protects the T2Lyme™ Panel, which allows for the rapid detection of Lyme disease-causing bacteria within 3 to 5 hours, addressing an unmet medical need.

How does the T2Lyme™ Panel improve Lyme disease diagnostics?

It enables quicker diagnosis compared to traditional methods, which may require weeks for antibody development, leading to timely treatment.

What is the market potential for the T2Lyme™ Panel?

With approximately 476,000 cases treated annually in the U.S., the T2Lyme™ Panel has significant market potential for effective Lyme disease diagnostics.

What is the technology behind T2 Biosystems' diagnostic products?

The products, including the T2Lyme™ Panel, utilize proprietary T2 Magnetic Resonance (T2MR) technology for rapid pathogen detection.

How many patents does T2 Biosystems currently hold?

T2 Biosystems has a total of 46 U.S. patents and 73 international patents, reflecting its innovative diagnostic technology.