T2 Biosystems Announces Collaboration with CDC to Detect Emerging Superbug Candida auris
CDC to Utilize T2Dx Instrument for Testing of Patient Samples and Monitoring Hospital Environments
New Application of T2MR Technology for Detection of Candida auris in Patient Skin, Patient Blood and Hospital Environmental Samples Now Available for Investigational Purposes
The use of the T2Dx Instrument for the detection of Candida auris represents multiple, new applications of the T2MR platform, the first for testing patient skin and blood samples, and the second for environmental surveillance to monitor outbreaks and the spread of the superbug. These applications are now available as research tools for investigational purposes in
The goals of the CDC-T2 Biosystems collaboration are to use the T2Dx Instrument to:
- Validate the detection of Candida auris from patient skin samples and hospital environmental samples.
- Validate a process for surveillance of Candida auris in healthcare facilities from skin and environmental samples.
- Assist state and local public health labs in combating the outbreak.
“The development of a rapid diagnostic for Candida auris is needed to combat this emerging threat and to enable patients to receive life-saving medicines in the critical care window while also isolating infected patients to prevent the spread of this disease throughout the hospital,” said
Candida auris is a multi-drug resistant pathogen recognized by the CDC as a “serious global health threat” because it can be resistant to “all three major classes of antifungal drugs” and difficult to identify. The CDC has also reported that more than 1 in 3 patients with Candida auris infections have died. Unlike most other species of Candida, Candida auris can spread quickly in a hospital making rapid identification and hospital environment surveillance a critical component of containing these outbreaks. Existing laboratory methods that detect Candida auris, including blood culture, suffer from prolonged detection times and low accuracy, which exacerbates the challenge in the fight to contain the superbug. Recently, reported cases have surged internationally, and the CDC has reported a significant increase in infected patients in
To date,
- Detection in blood and environmental and skin swab elution buffer at <10 CFU/mL;
- Detection in whole blood specimens from patients known to be infected with Candida auris;
- Lack of cross-reactivity with Candida species commonly misidentified as Candida auris; and
- Detection of all four known clades of Candida auris.
The Candida auris test was developed by
“We are excited to extend our T2MR platform beyond patient testing to environmental surveillance, broadening the number of our applications that may lower mortality rates,” said
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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 goals, future aspects of the collaboration with the CDC, possible effects of Candida auris, anticipated product benefits, strategic priorities, product expansion, pipeline or opportunities, growth expectations and market opportunities. 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, 2016, filed with the U.S. Securities and Exchange Commission, or SEC, on March 15, 2017, 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, it disclaims any obligation to do so, even if subsequent events cause its views to change. 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.
Company Contact:Darlene Deptula-Hicks ,T2 Biosystems SVP & Chief Financial Officer ddeptula@t2biosystems.com 603-553-5803 Media Contact:Amy Phillips ,Feinstein Kean Healthcare amy.phillips@fkhealth.com 412-327-9499 Investor Contact:Chris Brinzey ,Westwicke Partners chris.brinzey@westwicke.com 339-970-2843