T2 Biosystems Achieves Key Milestone with 250,000th Novel Sepsis Test Shipped Globally

Rhea-AI Summary

T2 Biosystems (NASDAQ: TTOO) has announced shipping over 250,000 sepsis tests globally, demonstrating growing adoption of their direct-from-whole-blood technology. A meta-analysis of 14 controlled studies showed their tests provide results 77 hours faster than blood culture-based diagnostics, with patients receiving targeted therapy 42 hours sooner and experiencing shorter hospital stays (5.0 fewer ICU days, 4.8 fewer hospital days).

A March 2024 study in the Journal of Clinical Microbiology highlighted the T2Resistance Panel's performance with 94.7% sensitivity and 97.4% specificity, delivering results in 4.4 hours versus 58.3 hours for standard methods. The company's FDA-cleared products, including the T2Dx Instrument, T2Bacteria Panel, and T2Candida Panel, can detect pathogens directly from whole blood in 3-5 hours without waiting for blood culture results.

Positive

• Milestone achievement of 250,000 sepsis tests shipped globally
• Superior performance metrics: 77 hours faster detection, 42 hours faster therapy delivery
• Reduced hospital stays: 5.0 fewer ICU days, 4.8 fewer hospital days
• High accuracy of T2Resistance Panel: 94.7% sensitivity, 97.4% specificity
• Competitive advantage: Only FDA-cleared product for direct whole blood pathogen detection

Negative

• None.

Insights

Medical Research Analyst

The achievement of 250,000 shipped sepsis tests represents significant market penetration for T2 Biosystems' innovative diagnostic technology. Meta-analysis data showing 77 hours faster detection and 42 hours faster targeted therapy demonstrates compelling clinical advantages over traditional blood culture methods. The 94.7% sensitivity and 97.4% specificity of the T2Resistance Panel, coupled with rapid 4.4-hour turnaround time, positions the company's technology as potentially transformative in sepsis care. With sepsis mortality increasing 8% per hour of delayed treatment, this speed advantage could translate to meaningful clinical outcomes and market opportunities.

Market Research Analyst

While the 250,000 test milestone indicates growing market acceptance, TTOO's micro-cap status ($7.8M) suggests significant growth potential remains untapped. The company's unique ability to detect pathogens directly from whole blood, without waiting for blood cultures, creates a compelling competitive advantage in the sepsis diagnostics market. Coverage of 75% of bacterial and 95% of Candida bloodstream infections positions their panels as comprehensive solutions. The FDA clearance for their core products and CE marking for the T2Resistance Panel in Europe provides multiple revenue streams and market expansion opportunities.

Milestone demonstrates the growing customer adoption of the Company’s proprietary technology

LEXINGTON, Mass., Dec. 17, 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 surpassed the shipment of 250,000 sepsis tests, marking a significant milestone that underscores the growing customer adoption of the Company’s direct-from-whole-blood technology.

A meta-analysis of 14 controlled studies, published in a peer-reviewed medical journal, compared T2 Biosystems’ sepsis tests to blood culture-based diagnostics, and showed that T2 Biosystems’ products provided: faster time to detection (e.g., species identification 77 hours faster), faster targeted therapy (e.g., patients testing positive with T2 Biosystems receiving targeted antimicrobial therapy 42 hours faster), and reduced length of stay (e.g., 5.0 fewer days in the ICU and 4.8 fewer days in the hospital). In March 2024, the Company announced the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy (i.e., 94.7% sensitivity, 97.4% specificity), rapid turnaround time (i.e., results available in 4.4 hours versus 58.3 hours), and clinical impact (i.e., clinical interventions in 41% of patients in the study; 24 of 59 patients).

“We are honored that hospitals have chosen to use our direct-from-blood diagnostic tests to care for hundreds of thousands of patients with bloodstream infections or sepsis, enabling clinicians to achieve faster targeted antimicrobial treatment,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Alternative diagnostics that that are used to identify sepsis-causing pathogens and antibiotic resistance first require a positive blood culture, which can take days, and it is well-understood that the risk of death increases by up to eight percent per hour of delayed targeted antimicrobial treatment.”

T2 Biosystems has developed and commercialized the T2Dx^® Instrument, the T2Bacteria^® Panel, and the T2Candida^® Panel, the only FDA-cleared products able to detect bacterial and fungal sepsis-causing pathogens directly from whole blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The T2Bacteria Panel detects six bacterial species that account for nearly 75% of all bacterial bloodstream infections in the U.S, and the T2Candida Panel detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S. The Company is also marketing and selling the CE-marked T2Resistance^® Panel in select European markets, which detects thirteen antibiotic resistance genes directly from whole blood, in just 3-5 hours, and which has also received FDA Breakthrough Device designation.

The Company’s competitors that market FDA-cleared products to detect sepsis-causing pathogens and antibiotic resistance are currently dependent on positive blood culture results. When these firms market that their products provide species identification results in 1-3 hours, or antibiotic susceptibility results in 7 hours, it is important to understand that these turnaround times are only after waiting 1-5 days for a positive blood culture. Further, if blood culture produces false negative results due to poor sensitivity, these blood culture-dependent diagnostics provide little to no value.

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 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, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. 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 likelihood that the customer adoption of the Company’s direct-from-whole-blood technology will continue to grow and hospitals will continue to choose the Company’s direct-from-blood diagnostic tests to care for their patients with bloodstream infections or sepsis; and all other 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, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, 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

FAQ

How many sepsis tests has T2 Biosystems (TTOO) shipped globally as of December 2024?

T2 Biosystems has surpassed 250,000 sepsis tests shipped globally, marking a significant milestone in customer adoption.

What is the time advantage of T2 Biosystems' sepsis tests compared to traditional blood cultures?

T2 Biosystems' tests provide species identification 77 hours faster than traditional blood culture-based diagnostics and enable targeted antimicrobial therapy 42 hours sooner.

What are the accuracy rates of T2 Biosystems' T2Resistance Panel according to the March 2024 study?

The T2Resistance Panel showed 94.7% sensitivity and 97.4% specificity, with results available in 4.4 hours compared to 58.3 hours for standard methods.

How much shorter are hospital stays for patients using T2 Biosystems' sepsis tests?

Patients using T2 Biosystems' tests experienced 5.0 fewer days in the ICU and 4.8 fewer days in the hospital overall.

What percentage of bacterial bloodstream infections can the T2Bacteria Panel detect?

The T2Bacteria Panel detects six bacterial species that account for nearly 75% of all bacterial bloodstream infections in the U.S.