The T2 Biosystems’ T2Dx<sup>®</sup> Instrument will be installed in the CDCs laboratory to test for and monitor hospital outbreaks of <i> Candida auris</i>. [T2 Biosystems]” width=”60%” height=”60%” /><br />
<span class=The T2 Biosystems’ T2Dx® Instrument will be installed in the CDCs laboratory to test for and monitor hospital outbreaks of Candida auris. [T2 Biosystems]

The U.S. Centers for Disease Control and Prevention (CDC) is to install T2 Biosystems’ T2Dx® Instrument in its laboratory to test for and monitor hospital outbreaks of the multidrug-resistant (MDR) fungal infection Candida auris, which is becoming a major health threat in hospital environments in the U.S. and on other continents.

CDC will use the T2 technology to monitor C. auris infections in hospitals around the country. The collaboration aims to validate use of the T2Dx system for identifying the infection in patient skin samples and hospital environmental samples, as well as validate a process for C. auris surveillance in healthcare facilities and help laboratories at the state and local levels to combat outbreaks. While the agreement with CDC focuses on evaluating the T2Dx technology for identifying C. auris, “the CDC has stated that the collaboration could expand to cover additional superbugs,” John McDonough, president and CEO at T2 Biosystems, indicated to GEN. The firm hasn’t disclosed how many of the T2Dx systems will be installed. “The CDC will use our instruments in their laboratory. We have not released additional information at this time.”

Discovered as recently as 2009, C. auris is an emerging MDR health threat that, unlike other strains of Candida, can spread rapidly in hospital environments, causing serious illness in hospitalized patients. The CDC suggests that more than one in three patients with invasive C. auris infection will die, and a number of strains are resistant to all three major classes of antifungal drugs.

Although very few cases of C. auris were identified in the U.S. prior to 2016, the CDC reported that the case count in 2017 had reached 112 by August 21. And at the end of 2016, the European Centre for Disease Prevention and Control had also confirmed the identification of hard-to-control outbreaks in the U.K. and Spain.

Fast identification and environmental surveillance are key to containing C. auris outbreaks. However, current methods used to detect the organism are slow and may incorrectly identify C. auris as a different Candida strain, GEN was told. “Blood culture is currently used at hospitals for patient testing, but it is too slow, and post-culture identification methods often misidentify C. auris as other Candida strains, a major issue,” McDonough explained. “The standard testing requires culturing samples, which can take up to 6 or more days, and Candida species have proven to be detected only about 50% of the time.…Home-brew PCR-based methods have been recently reported, but they lack the sensitivity to go direct-from-sample and require a positive blood culture sample.”

Some cases of C. auris are detected through culture based-diagnostics such as MALDI-TOF, or matrix-assisted laser desorption ionization–time of flight mass spectrometry, but again, the concern is that C. auris can’t be differentiated from other strains. Environmental testing is even more problematic, and takes even longer.  “This is an even slower process,” GEN was informed. “Testing of environmental and skin swabs requires 2 weeks of culturing prior to MALDI-TOF, which is a major bottleneck in infection control today.”

The T2Dx technology is already used commercially with the FDA-approved T2Candida® Panel, which can identify five other clinically relevant species of Candida (not including C. auris) in whole blood samples, within just 3 to 5 hours. T2 claims it has now demonstrated that the T2x Instrument can accurately detect C. auris in whole blood and in blood and environmental and skin swab elution buffers at levels of less than 10 CFU/mL. The technology can also identify all four known clades of C. auris, without cross-reactivity with other Candida species that are commonly misidentified using traditional methods.

“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,” McDonough stated. “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.”

The T2Dx instrument will be validated at the CDC laboratory to test for and monitor hospital oubreaks of  C. auris, and T2 projects that the technology could feasibly be used in hospitals directly. “We have already had hospitals reach out to us for potential use of the product,” McDonough acknowledged to GEN.

T2 is developing the T2MR technology for multiple applications. The firm’s T2Bacteria® Panel has been awarded a CE mark for commercial release in Europe and is available for research use in the U.S., where clinical development is ongoing. The firm is also developing a T2HemoStat™ Panel for hemostasis profiling and is working with Canon U.S. Life Sciences to develop the T2Lyme™ Panel for rapid diagnosis of Lyme disease. T2’s T2Sepsis Solution combines best standard of care with the T2Dx instrument, T2Candida Panel, and T2Bacteria Panel, for fast, accurate detection of sepsis-causing pathogens.