T2 Biosystems Advances to the Phase 2 in HHS and the Steven and Alexandra Cohen Foundation’s LymeX Diagnostics Prize
T2 Biosystems (TTOO) has advanced to Phase 2 of the LymeX Diagnostics Prize, aimed at developing innovative Lyme disease diagnostics. Their T2Lyme Panel, designed for early Lyme disease detection, has received Breakthrough Device Designation from the FDA and is patented. This prize competition stands to enhance Lyme diagnostics by offering cash prizes and resources for teams working on next-generation solutions. With $9 million available in future prizes, the initiative aims to foster a broader market response to Lyme disease, which affects approximately 476,000 people annually in the U.S. The Phase 2 cohort will submit concept papers in October 2023.
- T2 Biosystems advanced to Phase 2 of LymeX Diagnostics Prize.
- The T2Lyme Panel received FDA Breakthrough Device Designation.
- Patent granted for T2Lyme Panel enhances competitive positioning.
- $9 million in projected future prizes from the LymeX initiative.
- None.
LEXINGTON, Mass., Feb. 06, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that it has advanced to the Phase 2 accelerator in the U.S. Department of Health and Human Services (“HHS”) and the Steven & Alexandra Cohen Foundation’s (“Cohen Foundation”) LymeX Diagnostics Prize. The goal of the multiphase LymeX Innovation Accelerator (LymeX) prize competition is to nurture the development of diagnostics toward Food and Drug Administration (FDA) review.
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. In the last six months, the T2Lyme Panel 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 advanced to the Phase 2 accelerator in the LymeX Diagnostics Prize,” stated John Sperzel, Chairman and CEO of T2Biosystems. “We appreciate the leadership from HHS and the Cohen Foundation to 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.”
The LymeX Diagnostics Prize Virtual Accelerator provides a pathway to nurture the development of the next generation of Lyme disease diagnostics toward FDA submission and market. The current two-tier serological testing system to detect Lyme disease relies on the presence of antibodies, which often take four to six weeks after infection to become detectable in humans. This testing with a significant lag time, called a seronegative window of infection, delays diagnosis. Delayed diagnoses prevent timely crucial treatment interventions.
By using a prize competition, rather than relying on traditional grantmaking, the LymeX Diagnostics Prize offers cash prizes alongside a range of non-monetary resources. The competition is designed to stimulate the market for Lyme disease diagnostics by bringing together a diverse group of experts to address an unmet societal need. The LymeX Diagnostics Prize Phase 1 inspired 52 teams to submit innovative concepts, which judges evaluated, and HHS awarded
The LymeX Diagnostics Prize Virtual Accelerator offers the cohort access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review. A selection of accelerator resources will be made available to the public on the competition website to support broader innovation in Lyme disease diagnostics and treatment.
In October 2023, the cohort will submit concept papers that detail solution refinement, clinical and patient input, and a roadmap from lab to market. The competition judging panel—composed of experts across sectors such as biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, exponential innovation, and ethics—will evaluate eligible submissions according to official Phase 2 evaluation criteria. Based on the judges’ evaluations, the panel will recommend up to five Phase 2 winners of the LymeX Diagnostics Prize.
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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 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.
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, timing of development of an LDT for 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, 2021, filed with the U.S. Securities and Exchange Commission, or SEC, on March 23, 2022, 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
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