Real-world data to highlight substantial impact T2Bacteria® has made on patient outcomes
LEXINGTON, Mass., June 20, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, will share multiple updates regarding the clinical utility of its expanding portfolio of groundbreaking rapid diagnostics and technology during ASM Microbe 2019 in San Francisco, CA from June 19 to 24.
“The T2Bacteria® and T2Candida® panels are the first-and-only FDA cleared tests that can provide direct-from-blood, rapid diagnostics for patients suspected of blood stream infection or sepsis. This patent-protected technological innovation is a major accomplishment, particularly when considering the decades of attempted development efforts from over a half dozen other companies that did not yield FDA cleared tests. Since introducing our T2Bacteria Panel at last year’s meeting, we are proud to share that we’ve altered the course of clinical treatment in meaningful ways, making a significant impact on healthcare facilities and the patients they treat,” said John McDonough, president and chief executive officer of T2 Biosystems. “We look forward to our time at ASM Microbe 2019 as an opportunity to connect with the world’s leading microbiologists and communicate this impact, along with our plans for continuing on this disruptive path as we work to address unmet needs related to sepsis prevention in today’s healthcare environment.”
Throughout the show, T2 Biosystems will offer attendees multiple opportunities to experience new data that underscore the benefits experienced by facilities who have adopted T2 technology. Tom Lowery, PhD, chief scientific officer, T2 Biosystems, will present an Industry Education Workshop, Rapid, Direct-from-Blood Diagnostics that Enable Changes in Clinical Decisions, on Friday, June 21 from 12:00 – 12:45 pm in Theater North in the Exhibit Hall of The George R. Moscone Convention Center.
The presentation will highlight clinical updates regarding current and future applications of T2 technology, including:
- T2Bacteria provides actionable clinical information: New T2Bacteria Panel clinical data being generated by independent commercial users shows its ability to benefit tested patients in the emergency department by providing information that leads to more rapid time to delivery of effective therapy, de-escalation of unnecessary therapy, and helping avoid premature discharge and readmission to the emergency department.
- Meta-analysis of 70 studies highlights significant challenges of empiric therapy (without T2Bacteria and T2Candida): 46.5% of patients are on inappropriate antibiotic therapy with empiric therapy alone, while >90% are on effective therapy after accurate species identification, such as provided by T2Bacteria and T2Candida.
- T2Bacteria clinical patient selection algorithms demonstrate significant clinical impact: Dr. Lowery will review T2Bacteria patient selection algorithms implemented by T2Bacteria customers and summarize emerging clinical utility data of 120 clinical cases demonstrating significant clinical impact. He will also detail multiple cases demonstrating the impact and potential impact of T2Bacteria on clinical outcomes.
- T2Resistance™ Panel provides ≥ two day time advantage compared to conventional methods: The T2Resistance Panel, which was recently granted Breakthrough Device designation by the FDA, is designed to detect 13 resistance genes from both gram-positive and gram-negative pathogens direct from blood. Initial data demonstrates T2Resistance identifies these resistance genes with an average time of 5.3 hours compared to an average of 30 hours (and up to 95 hours) with conventional methods. The T2Resistance Panel is expected to be available for research use only (RUO) in the U.S. and receive CE-Mark for commercial availability in Europe by the end of 2019.
- T2MR® Technology has the potential to provide coverage for ≥99% of bloodstream infections: Dr. Lowery will present feasibility data demonstrating that the T2MR Technology has the capability to potentially detect >250 pathogen species, which would cover ≥99% of blood-borne pathogens responsible for bloodstream infections and sepsis. It has also demonstrated the ability to potentially detect resistance markers for all blood-borne antibiotic resistance threats identified by the Centers for Disease Control (CDC). These diagnostic capabilities could allow the Company to develop a panel that provides comprehensive coverage of bloodstream infections.
The Company will also participate in an Industry & Science Tech Talk on Saturday, June 22 at 11:00 am in the Innovation Zone (Booth #4811) and host multiple in-booth presentations, including Rapid Culture Independent Detection of Resistance Genes Direct from Whole Blood by T2MR® throughout the show in Booth #1443, where its products will be on display for the duration of the meeting.
T2 Biosystems is the company behind the T2Bacteria Panel, the first and only FDA-cleared test to identify sepsis-causing bacterial pathogens directly from whole blood in 3 to 5 hours without the need to wait for blood culture, allowing patients to be placed on targeted antibiotic therapy faster. The T2Bacteria Panel is one of several panels that are approved or in development that are run on the Company’s T2Dx® Instrument, which is powered by miniaturized magnetic resonance (T2MR®) technology.
About T2 Biosystems
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, 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, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
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 additional patients, timing of testing patients, anticipated product benefits, strategic priorities, product expansion or opportunities, growth expectations or targets, timing of FDA filings or clearances and anticipated operating expenses, 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, 2018, filed with the U.S. Securities and Exchange Commission, or SEC, on March 14, 2019, 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.
Gina Kent, Vault Communications
Zack Kubow, W2O Group
Source: T2 Biosystems, Inc.