LEXINGTON, Mass., Feb. 07, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that the U.S. Department of Health and Human Services (“HHS”) and the Steven & Alexandra Cohen Foundation (“Cohen Foundation”) have selected T2 Biosystems as a Phase 2 winner in the LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics. As a Phase 2 winner, T2 Biosystems will receive $265,000.
T2 Biosystems’ solution, 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. T2 Biosystems has previously received Breakthrough Device Designation from the U.S. Food and Drug Administration and received a patent from the U.S. Patent and Trademark Office, both covering the T2Lyme Panel.
“We are thrilled to announce that we have been selected as a Phase 2 winner in the LymeX Diagnostics Prize,” stated John Sperzel, Chairman and CEO of T2Biosystems. “We appreciate the continued leadership from HHS and the Cohen Foundation to support innovation and advance next generation Lyme diagnostics, and we are grateful to receive this support to advance our T2Lyme Panel for the detection of early Lyme disease.”
There is a critical need for new Lyme disease diagnostics. With an estimated 476,000 cases annually, Lyme disease is by far the leading vector-borne disease in America. The current diagnostic process, a two-tiered antibody testing algorithm originally developed in 1994 for disease surveillance and not as a stand-alone diagnostic test, relies on the presence of antibodies and can only be used accurately four to six weeks after infection. Early diagnosis of Lyme disease is critical. If left untreated, the debilitating disease can become harder to eradicate and spread throughout the body.
From January to September 2023, 10 entities participated in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections in people. The Phase 2 virtual accelerator offered access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the cohort progress toward FDA review.
Phase 2 awarded $2 million in prizes based on the teams’ interim and final submissions. Each team’s final concept paper described how they are developing their diagnostic, included clinical and patient input, and proposed a roadmap from laboratory to market that includes FDA review. The competition judging panel—composed of experts in areas such as vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology—evaluated eligible submissions according to official Phase 2 evaluation criteria.
Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Steven & Alexandra Cohen Foundation, at least $7 million in additional LymeX prizes are projected to be available in proposed future phases.
Visit LymeXDiagnosticsPrize.com for more information and subscribe to the competition newsletter to receive future updates.
About Lyme Disease:
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.
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 through the rapid detection of bacterial and fungal pathogens which allow faster targeted antimicrobial treatment. T2 Biosystems’ products are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance® Panel, expanded T2Bacteria Panel to add Acinetobacter baumannii, the Candida auris test, and the T2Lyme™ Panel. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our plan to develop and commercialize a diagnostic test for the detection of early Lyme disease, the capability of the T2Lyme Panel to detect early Lyme disease, the market opportunity for a diagnostic test for early Lyme disease, status of product development pipeline, product demand, and commitments or opportunities, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
