T2 Biosystems Initiates Studies to Add Acinetobacter Baumannii to the FDA-Cleared T2Bacteria Panel
T2 Biosystems (NASDAQ:TTOO) announced the initiation of studies to expand its FDA-cleared T2Bacteria® Panel to include the detection of Acinetobacter baumannii, a pathogen linked to severe bloodstream infections in critically ill patients.
Acinetobacter infections are prevalent in healthcare settings and are resistant to many antibiotics. The T2Bacteria Panel, able to provide rapid pathogen detection in whole blood within 3 to 5 hours, is currently FDA-cleared to identify other sepsis-causing pathogens. This expansion aims to enhance patient care and improve treatment outcomes for those at risk.
- Initiation of studies to expand T2Bacteria Panel to include Acinetobacter baumannii.
- T2Bacteria Panel provides rapid detection of pathogens in 3 to 5 hours.
- None.
LEXINGTON, Mass., Oct. 20, 2022 (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 initiated studies to expand the number of pathogens detected on the FDA-cleared T2Bacteria® Panel to include the detection of Acinetobacter baumannii.
A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to fulminant septic shock. A. baumannii infections typically occur in people in healthcare settings and pose risk to those who are on ventilators; have devices such as catheters; have open wounds from surgery; are in intensive care units; or have prolonged hospital stays. In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of
“We are excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel. In the U.S., Acinetobacter infections rarely occur outside of healthcare settings and can disproportionally impact those with weakened immune systems, chronic lung disease, or diabetes,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Acinetobacter can be resistant to many antibiotics, including carbapenems, which highlights the importance of rapid detection and targeted antimicrobial treatment.”
The T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in 3 to 5 hours, without the need to wait days for a positive blood culture. The FDA-cleared T2Bacteria Panel currently detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli, and the CE marked version detects the aforementioned pathogens plus A. baumannii.
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, T2Bacteria® Panel, T2Candida® Panel, T2Resistance® Panel, and T2SARS-CoV-2™ Panel and are powered by the Company’s proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat Panel, T2Cauris™ Panel, T2Lyme™ Panel, as well as additional 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 T2 Biosystems’ to expand the number of pathogens detected on the T2Bacteria Panel, the benefits of T2 Biosystems’ technology, or the impact that rapid detection of pathogens can have on the lives of patients, 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
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