U.S. Department of Health and Human Services and Steven and Alexandra Cohen Foundation Name T2 Biosystems a Phase 2 Winner in the LymeX Diagnostics Prize

Rhea-AI Summary

T2 Biosystems, Inc. has been selected as a Phase 2 winner in the LymeX Diagnostics Prize, receiving $265,000 to advance the T2Lyme Panel for the detection of early Lyme disease. The T2Lyme Panel is designed to run on the FDA-cleared T2Dx Instrument and detect Borrelia burgdorferi, the bacteria that causes Lyme disease. The current diagnostic process for Lyme disease relies on the presence of antibodies and can only be used accurately four to six weeks after infection, making early diagnosis critical. The competition judging panel evaluated submissions based on official Phase 2 evaluation criteria, and at least $7 million in additional LymeX prizes are projected to be available in proposed future phases.

Insights

Medical Research Analyst

The recognition of T2 Biosystems as a Phase 2 winner in the LymeX Diagnostics Prize signifies a notable advancement in the field of infectious disease diagnostics. The award, which comes with a $265,000 prize, underscores the potential of the T2Lyme™ Panel to address a significant unmet need in the early detection of Lyme disease. Current diagnostic methods, based on antibody detection, have limitations regarding the timeliness and accuracy of diagnosis, particularly in the early stages of infection. The T2Lyme Panel's direct-from-blood approach could circumvent these issues, offering a more immediate and accurate diagnosis that would enable timely treatment, potentially reducing the long-term health impacts and healthcare costs associated with late-stage Lyme disease.

From an industry perspective, the development and potential market entry of T2 Biosystems' T2Lyme Panel align with a broader trend towards precision medicine and personalized healthcare solutions. Given the high prevalence of Lyme disease and the shortcomings of existing diagnostic methods, the T2Lyme Panel could capture significant market share if it demonstrates superior performance in clinical trials and receives FDA approval. Moreover, the breakthrough device designation previously granted by the FDA may facilitate an expedited review process, potentially leading to quicker market access. The patent awarded to T2 Biosystems for the T2Lyme Panel further solidifies its competitive position by providing intellectual property protection.

Healthcare Economist

The economic implications of improved diagnostics for Lyme disease are substantial. Lyme disease, with an estimated 476,000 cases annually in the United States, represents a significant burden on the healthcare system. The direct and indirect costs associated with delayed or incorrect diagnoses are considerable, including prolonged courses of treatment, increased disability claims and reduced workforce productivity. The T2Lyme Panel's ability to provide early and accurate detection could therefore result in significant cost savings for both healthcare providers and payers by reducing the need for extended treatments and mitigating the progression of the disease.

Furthermore, the financial support from HHS and the Cohen Foundation not only validates the scientific and societal value of T2 Biosystems' innovation but also reflects a strategic investment in public health. The continued funding for the development of such diagnostic tools, as indicated by the $10 million pledge from the Cohen Foundation for future phases of the LymeX Diagnostics Prize, represents a commitment to addressing vector-borne diseases that have widespread health and economic consequences. The potential for additional prize funding could incentivize further innovation in the sector and stimulate competition, which may lead to a broader range of diagnostic solutions and cost efficiencies over time.

Market Research Analyst

The announcement that T2 Biosystems has been selected as a Phase 2 winner in the LymeX Diagnostics Prize could have positive implications for the company's market position and investor perception. The prize money, while not a transformative sum for a biotech company, provides non-dilutive funding that can support the continued development and potential commercialization of the T2Lyme Panel. The recognition by a panel of expert judges also serves as a third-party endorsement of the technology's potential, which can be influential in attracting additional investment and partnerships.

Investors and stakeholders will likely monitor the progress of the T2Lyme Panel closely as it moves towards FDA review. Success in the market will depend on several factors, including the demonstration of clinical utility, cost-effectiveness and integration into existing healthcare workflows. The company's ability to effectively market the T2Lyme Panel and secure reimbursement from insurers will be critical for widespread adoption. Additionally, the patent protection and breakthrough device designation may provide T2 Biosystems with strategic advantages in a competitive diagnostics market.

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

FAQ

What is the T2 Biosystems, Inc. ticker symbol?

The ticker symbol for T2 Biosystems, Inc. is TTOO.

What is the LymeX Diagnostics Prize?

The LymeX Diagnostics Prize is a prize competition to accelerate the development of Lyme disease diagnostics.

What is the T2Lyme Panel?

The T2Lyme Panel is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2Dx Instrument and detect Borrelia burgdorferi, the bacteria that causes Lyme disease.

What is the current diagnostic process for Lyme disease?

The current diagnostic process for Lyme disease relies on the presence of antibodies and can only be used accurately four to six weeks after infection.

What is the purpose of the Phase 2 virtual accelerator for the LymeX Diagnostics Prize?

The Phase 2 virtual accelerator is designed to help participants refine their concepts for detecting active Lyme disease infections in people, offering access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities.