Panel is the only direct-from-blood diagnostic designed to detect genetic markers associated with antibiotic-resistant bloodstream infections
Panel is the only direct-from-blood diagnostic designed to detect genetic markers associated with antibiotic-resistant bloodstream infections
September 30, 2019 07:30 ET | Source: T2 Biosystems, Inc.
LEXINGTON, Mass., Sept. 30, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, announced today that its T2ResistanceTM Panel, which received Breakthrough Device Designation from the Food and Drug Administration (FDA) earlier this year, is now available as a research use only (RUO) test in the United States. The T2Resistance Panel also remains on track to receive CE-Mark for commercial availability in Europe by the end of 2019.
The T2Resistance Panel RUO identifies 13 of the most serious resistance genes on the antibiotic-resistance threat list published by the Centers for Disease Control and Prevention (CDC), including genes indicating resistance to common empiric antibiotic therapies such as carbapenems, vancomycin, penicillin and more. It is the first system that can detect resistance markers directly from whole blood—in three to five hours.
“With the T2Resistance Panel’s RUO availability, researchers will be able to demonstrate, understand the value, and the potential benefits of rapid detection of the genes associated with antibiotic resistance, including the reduction of unnecessary antibiotic use, which is a key driver of resistance,” said John McDonough, chairman and chief executive officer at T2 Biosystems. “This milestone takes us even closer to bringing this important technology to market for clinical use, which will have the potential to further help improve patient outcomes associated with bloodstream infections and sepsis.”
The panel utilizes the same T2Dx® Instrument as the T2Bacteria® and T2Candida® Panels – the only FDA-cleared panels that can detect sepsis-causing pathogens directly from a patient’s blood sample, without the need to wait for a blood culture. A positive blood culture takes one to five or more days before subculture and antimicrobial susceptibility testing (AST) or genomic testing can commence, which is the current pathway to identifying antibiotic resistance. Additionally, it can take four blood culture sets to detect what T2MR® technology can detect in a single blood draw. In contrast, the T2Bacteria and T2Candida Panels’ sensitivity and ability to provide results faster are key advantages that enable positive changes in clinical decisions and outcomes.
“By providing identification and genotypic antibiotic resistance marker results in only a few hours from a blood sample, clinicians will be able to more effectively treat their potentially bacteremic patients at risk of resistant infections, and avoid unnecessary therapies that further promote antibiotic resistance,” said Dr. George Pankey, Director of Infectious Disease Research at Ochsner Clinic Foundation. “The T2Resistance Panel promises to be a powerful stewardship tool when clinically available, as it will help ensure that patients are on the most appropriate therapy, and identify those patients with resistant bloodstream infections faster than any other diagnostic.”
Recently, T2 Biosystems was awarded a milestone-based contract of initial value of $6 million with a potential value of up to $69 million, if all contract options are exercised, from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services’ (HHS). Additionally, the Company’s T2Bacteria Panel was the first in-vitro diagnostic test to receive approval for a New Technology Add-on Payment (NTAP) by the United States Centers for Medicare & Medicaid Services (CMS).
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, which was recently announced as the first and only in-vitro diagnostic test to receive approval for a New Technology Add-on Payment (NTAP) by CMS, 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.
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 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.
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