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T2 Biosystems Announces FDA 510(k) Submission to Expand Use of the FDA-Cleared T2Candida Panel to Include Pediatric Testing

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T2 Biosystems, a leader in rapid sepsis detection, submits FDA premarket notification for pediatric testing expansion of its FDA-cleared T2Candida Panel. The panel can detect sepsis-causing Candida pathogens directly from blood in just 3-5 hours, with a higher detection rate and faster species identification compared to blood culture. The submission marks an important milestone in the company's commitment to expanding the clinical utility of its sepsis test panels.
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The submission of a 510(k) premarket notification by T2 Biosystems to the FDA for the expansion of its T2Candida Panel to include pediatric testing is a significant development in the field of medical diagnostics. The T2Candida Panel's ability to rapidly detect sepsis-causing Candida directly from blood samples is a critical advancement, particularly as it pertains to pediatric care. The current standard of blood cultures can take days to yield results, which is detrimental in sepsis management where every hour counts. The potential pediatric application of this technology could drastically reduce diagnosis time, thereby enabling quicker treatment interventions and potentially improving patient outcomes.

From a medical research perspective, the reported sensitivity and specificity of the T2Candida Panel in studies suggest that it could become a preferred method for diagnosing invasive candidiasis in children. The economic implications are also notable, with the potential to significantly reduce hospital stays and associated costs by an average of $92,000 per case. These figures are substantial when considering the scale of pediatric admissions for invasive candidiasis annually. The long-term impact on healthcare expenditure could be transformative, especially if similar outcomes are replicated across other institutions and geographies.

Examining the economic implications of the T2Candida Panel's expanded use, the potential to decrease the length of hospital stays by an average of 21 days presents a compelling cost-saving opportunity for healthcare systems. The direct costs associated with extended hospital stays are significant, encompassing not only the care required for the individual patient but also the opportunity costs related to bed availability and resource allocation. By reducing the time to diagnosis and subsequent treatment initiation, the T2Candida Panel could alleviate some of the financial burden on healthcare facilities.

Furthermore, the increased detection rate of the T2Candida Panel compared to traditional blood cultures could lead to a decrease in morbidity and mortality rates among pediatric patients. This improvement in patient outcomes has the potential to enhance the reputation and competitiveness of healthcare providers that adopt this technology, which could indirectly influence market dynamics within the healthcare sector. The broader adoption of this panel could also drive down costs through economies of scale, making it a more accessible option for a wider range of healthcare facilities.

The strategic move by T2 Biosystems to seek FDA clearance for pediatric testing of its T2Candida Panel could have a significant impact on the company's market position. This expansion into pediatric diagnostics opens up a new demographic and could lead to increased market penetration and revenue streams. Given the high prevalence of invasive Candida infections and the critical need for rapid diagnosis in pediatric care, the market demand for such a diagnostic tool is likely to be robust.

Investors should monitor the FDA's decision closely, as a favorable outcome could catalyze T2 Biosystems' stock performance. The company's ability to capitalize on this potential new indication may also hinge on its marketing strategy and partnerships with hospitals and clinics. Successful dissemination and adoption of the T2Candida Panel in the pediatric space could serve as a bellwether for the company's future innovations and their potential market impact. It is crucial to consider the competitive landscape as well, noting how T2 Biosystems' technology stacks up against emerging diagnostic technologies and existing standard practices.

LEXINGTON, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the use of its FDA-cleared T2Candida® Panel to include pediatric testing.

The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the FDA-cleared T2Dx® Instrument and simultaneously detects five Candida species – including Candida albicansCandida tropicalisCandida parapsilosisCandida krusei, and Candida glabrata. According to the U.S. Centers for Disease Control and Prevention, up to 95% of all invasive Candida infections in the U.S. are caused by the five Candida species detected by the T2Candida Panel.

According to the Journal of Fungi, a peer-reviewed scientific journal that provides an advanced forum for studies related to pathogenic fungi, Candida species are a major contributor to morbidity and mortality in hospitalized children. Additionally, children with invasive candidiasis present a significant burden to the U.S. healthcare system, with a mean increased hospital length of stay of 21 days and approximately $92,000 in excess hospital costs.

"This FDA submission marks another important milestone in our commitment to expand the clinical utility of our sepsis test panels and we look forward to working through the premarket review process to obtain clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Candidiasis disproportionally affects critically ill children, and we believe a pediatric testing claim for our FDA-cleared T2Candida Panel will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.”

A Journal of Clinical Microbiology (2022) study conducted at the Bambino Gesù hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture. The study also found a higher detection rate with the T2Candida Panel as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by the T2Candida Panel and missed by blood culture. In addition, a prospective observational study published in Clinical Infectious Diseases (2022) evaluated the performance of four pre-blood culture tests for detecting the presence of invasive candidiasis in pediatric patients and found that the T2Candida Panel had the highest sensitivity and specificity of all four assays among five hundred patients enrolled. T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.

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, the T2Biothreat™ 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 T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. 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 the ability of the T2 Candida Panel to detect Candida species in pediatric patients, the likelihood that the FDA will approve the expanded use of the T2Candida Panel, and the ability of the T2Candida Panel to allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients, as well as statements that include the words “expect,” “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, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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 


T2 Biosystems announced the submission of a 510(k) premarket notification to the U.S. FDA to expand the use of its FDA-cleared T2Candida Panel to include pediatric testing.

The T2Candida Panel can detect sepsis-causing Candida pathogens directly from blood, including five Candida species - Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.

The submission is important as it marks a milestone in T2 Biosystems' commitment to expanding the clinical utility of its sepsis test panels.

The T2Candida Panel provides faster species identification results and has a higher detection rate compared to blood culture, leading to improved outcomes and reduced costs for pediatric patients.

The study found that pediatric patients suspected of fungal bloodstream infections tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture, with a higher detection rate and additional probable or possible fungal bloodstream infections detected.

The study evaluated the performance of four pre-blood culture tests for detecting the presence of invasive candidiasis in pediatric patients and found that the T2Candida Panel had the highest sensitivity and specificity among five hundred patients enrolled.
T2 Biosystems Inc

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t2 biosystems is developing innovative diagnostic products to improve patient health. with two fda-cleared products targeting sepsis – the cause of one out of two hospital deaths - and a range of additional products in development, t2 biosystems is an emerging leader in the field of in vitro diagnostics. our initial development efforts target sepsis, hemostasis, bacteria and lyme disease, which are areas of significant unmet medical need. the company is utilizing its proprietary t2 magnetic resonance platform, or t2mr®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. at t2 biosystems, we know that our passion to advance the medical diagnostic landscape relies on our ability to attract and retain the very best people in the world – and to encourage them to flourish. we invite you to apply for one of our open positions at www