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T2 Biosystems (TTOO) Announces Collaboration With CDC To Detect Emerging Superbug Candida Auris



9/6/2017 10:39:43 AM

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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

LEXINGTON, Mass., Sept. 06, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced that the Centers for Disease Control and Prevention (CDC) has agreed to utilize the T2Dx Instrument in their laboratory for testing and monitoring the emergence and outbreaks of the superbug Candida auris in hospitals around the country. The T2MR platform may also be expanded for the detection of future superbug threats.

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 United States and Europe.

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 Cornelius Clancy, MD, Director of the Mycology Program and Chief of the Infectious Diseases Section at VA Pittsburgh Healthcare System. “I am excited that the proven T2MR platform is being applied to solve this urgent public health need.”

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 the United States. According to the European Centre for Disease Prevention and Control, hospital outbreaks have occurred in the United Kingdom and Spain. Because Candida auris can be resistant to most treatment options and can spread so quickly, these hospital outbreaks have been difficult to contain by even the most enhanced control measures.

To date, T2 Biosystems has demonstrated the following performance in the detection of Candida auris:

  • 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 T2 Biosystems using organisms from the FDA-CDC Antimicrobial Resistance Isolate Bank.

“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 John McDonough, president and chief executive officer of T2 Biosystems. “Candida auris could become a major outbreak without the appropriate tools to control it and we are pleased to use our platform to contribute to containing this emerging healthcare threat by enabling rapid species level identification. The T2MR platform is well-positioned to rapidly combat emerging superbugs and we are excited to collaborate with the CDC on the most pressing challenges in healthcare.”

T2 Biosystems is also conducting a study in Europe that has demonstrated the ability to detect Candida auris directly in patient blood specimens. Both the clinical and environmental surveillance sample and whole blood sample tests are designed to work on the T2Dx Instrument that currently runs tests to detect other Candida species, getting results in 3 to 5 hours, without the need for blood culture. The T2Dx Instrument also runs the T2Bacteria Panel which is CE marked and commercially available in Europe, and available for use today in the United States as a Research Use Only product.

About T2 Biosystems
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today. The T2Sepsis SolutionTM is a unique approach that combines the best standard of care for the management of sepsis patients with T2 Biosystems’ products, including the T2Dx® Instrument and T2Candida® Panel, and the T2Bacteria® Panel, which is commercially available in Europe and other countries that accept the CE mark and available for research use only in the U.S. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. Hospital customer experience has demonstrated faster time to effective treatment, shortened ICU and hospital lengths of stay, reduced use of unnecessary antifungals, and millions of dollars in savings. T2 Biosystems has an active pipeline of future sepsis products including additional species and antibiotic resistance, as well as tests for Lyme disease and hemostasis. 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 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


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