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Gregorio Marañón Hospital in Madrid, Spain

Two 2018 studies from Gregorio Marañón Hospital in Madrid, Spain reported findings of the ability of the T2Candida® Panel to predict patient outcomes:

 

  • Strong indicator of complications: Positive T2Candida Panel results identified patients who had an over 30x increased likelihood of developing health complications, including mortality.
  • Strong indicator of poor outcomes: The T2Candida Panel is a better predictor of patients at risk of having poor outcomes than existing diagnostic tests. A negative T2Candida Panel result may significantly shorten the duration of antifungal therapy for 67% of patients.
  • Improved distinction between complicated and uncomplicated infection: The T2Candida Panel distinguishes between complicated and uncomplicated infection better than available diagnostic tests.

 

“The predictive value of the T2Candida Panel represents an important advance in our understanding of the clinical uses of T2Dx diagnostics. A T2Candida Panel positive demonstrated a 30x increase in the likelihood of a complicated infection and showed significant advantages over beta-D-glucan, blood culture and CAGTA,” said Patricia Muñoz, M.D., Ph.D., Division of Clinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Madrid, Spain. “Together, these studies demonstrate that the T2Dx Instrument is a powerful stewardship tool that can help inform clinicians when they can safely reduce the use of antimicrobial drugs – or when a patient needs more aggressive treatment.”

T2Candida data published in 2019 from a high-risk ICU population at Righospitalet in Denmark found “T2Candida was superior to blood culture and mannan antigen and may improve diagnosis.”

The study found 10/11 T2Candida positives were supported by culture isolates. The authors point out that T2Candida performance maybe even better but bias is introduced by the imperfect gold standard.

The paper shows T2Candida positivity for an average of 3 days longer than blood culture. The authors discuss how T2Candida may be able to support stewardship efforts because the resolution of symptoms and T2Candida negativity may be able to reduce the appropriate duration of therapy to shorter than the standard 14 days.

A graph of the species that the T2Candida is able to identify

Read the poster presented at ASM Microbe (2016) in Boston, MA, by investigators from Statens Serum Institut.

Prof. Maurizio Sanguinetti, MD of Gemelli Hospital, Italy presented at the GREAT conference how T2Bacteria can help critical care and emergency medicine clinicians to:

  • Rapidly diagnose and treat some of the most common and deadly pathogenic organisms.
  • Demonstrate how rapid diagnostics can be a “game changer” in the microbiology lab.

The delay of microbial culture results often make them unhelpful for the clinician, but T2Bacteria achieves the “need for speed” in the clinical setting. Prof. Sanguinetti presented Gemelli Hospital’s T2Bacteria data published in the Journal of Antimicrobial Chemotherapy demonstrating:

  • Positive results more than 4.5 times faster than blood culture
  • Negative results more than 20 times faster than blood culture
  • 66.7% of the clinically infected patients missed by blood culture were correctly identified by T2Bacteria and these patients were being inappropriately treated at the time of the T2Bacteria result.

A powerful case study from Spain was published in the peer-reviewed Medical Mycology Case Reports. The study details how the T2Candia Panel contributed to the healthy discharge of a 1-year-old transplant patient suspected of sepsis by providing infection results far earlier than blood culture and leading to more targeted antifungal therapy. The T2Candida Panel provided “optimal management of candidemia in this patient” and led to targeted therapy in hours of the first blood draw (while blood culture was sterile).

A chart showing how the T2Candida was able to identify pathogens faster than blood cultures

Fig. 1. Timeline of candidemia diagnosis and candidemia clearance through simultaneous blood cultures and T2Candida® tests.

Falces-Romero I., et al. Medical Mycology Case Reports, 2018.

Located in Pittsburgh, Pennsylvania, UPMC is an over 8,000 bed, a not-for-profit health system that includes 40 hospitals.

Why T2?

“The results from the T2Bacteria pivotal clinical trial were impressive, demonstrating excellent performance and advantages over blood culture,” said Minh-Hong Nguyen, MD, director, Antimicrobial Management Program and director, Transplant Infectious Diseases, UPMC. “T2Bacteria’s detection of bloodstream infections and fast species identification at high sensitivity will expedite life-saving interventions such as the targeting of therapy within hours of blood draw.” 1

“I was pleased to see that T2Candida has become a standard during any discussion regarding rapid diagnostics and antimicrobial stewardship,” said Dr. Clancy. “I believe that the hospitals using it are seeing strong value for their patients as well as better management of the drugs that lead to high resistance and costs.” 2

MICU pilot program

Led to 47% reduction in antifungal expenditure; Median days of therapy pre-intervention vs. post-intervention: 26 days vs. 15.5 days (p=0.005)

T2Bacteria Covers 71% of Gram-negative bacteria at hospital presentation and detects >50% of all BSI

​​……………………………………….

1. Nguyen, MH, T2 Biosystems Press Release, 2018
2. Clancy, N, T2 Biosystems Press Release, 2017
3. Shields R, et al. Poster Presentation, IDWeek, 2018

Located in Detroit, Michigan, Henry Ford Health System is an over 2,300-bed, not-for-profit hospital system.

Why T2?

“This technology has shown it can expedite the detection of candidemia. As a result, patients receive more prompt and appropriate antifungal therapy.” – Rachel Kenney, PharmD, Henry Ford study co-author

Faster Targeted Therapy

The median time to appropriate antifungal therapy was reduced from 39 hours to 22 hours (P=0.003). Patients tested with the T2Candida were appropriately treated in a median of 5 hours, compared to 44 hours with blood culture1

Reduced Length of Stay

Henry Ford reported a reduced median ICU length of stay by 7 days and an overall 4 day reduction1

Improved Patient Outcomes

Reduction in occurrence of ocular candidiasis cases were (P<0.28)

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1.  Wilson N, et al. Journal of Antimicrobial Stewardship, 2017

Located in Fort Myers, Florida, Lee Health is the largest healthcare system in Southwest Florida consisting of four acute care and two specialty hospitals and over 1,400 beds.

Why T2?

“This data demonstrates that innovation at Lee Health is leading to improved care for our patients and also reducing costs,” said John Armistead, Lee Health System Director Pharmacy. “The testing is helping to get our patients suspected of sepsis on the right therapy faster.” 2

Faster Targeted Therapy

T2Candida enabled patients to receive targeted therapy 28 hours faster. Patients suspected of a Candida infection that were tested on the T2Dx received targeted therapy nearly 6 times faster, in only 6 hours compared to conventional practices that took 34 hours.

Improved stewardship and pharmacy savings

The major findings in this study are the decreased time to initiation of targeted antifungal therapy when a T2Candida-directed treatment strategy was employed versus that of a BC-directed therapy approach and the avoidance of empiric therapy in 58.4% (101/173) of T2Candida-negative patients.2

The decreased utilization of empirical micafungin therapy observed in Phase 2 would result in a total savings of $280 per tested patient in antifungal costs alone when compared with historical control data from Phase 1.2

Faster Results

In a separate study, the T2Bacteria Panel allowed testing from whole blood samples and provided final results within 4 hours. T2Bacteria Panel provided positive and negative results approximately 20 hours and 122 hours sooner than blood cultures, respectively (p<0.001). T2Bacteria Panel identified all organisms identified by blood cultures of the bacteria included on the panel.3

Stewardship Tool

In the same study, a total of 36 opportunities for de-escalation were identified, such a potential to de-escalate coverage for S. aureus and/or P. aeruginosa. The high negative predictive value of the T2Bacteria Panel suggests utility in guiding early antibiotic de-escalation of coverage for organisms not identified.3

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1. Lee Health System Press Release, March 28, 2018
2. Patch PM, et al. Journal of Antimicrobial Chemotherapy, 2018
3. Weisz E, et al. White Paper, 2018

Located in Huntsville, Alabama, Huntsville Hospital is a large community and teaching hospital with over 940 beds.1 ​

Why T2?

“With the T2Direct Diagnostics, our hospital is not only reducing the use of antifungal therapy, we’re also identifying far more infected patients than was possible with blood culture,” Dr. Jonathan D. Edwards, Pharm.D., BCPS (AQ-ID), BCGP, Huntsville Hospital1

Proven performance and detection of Candida infections missed by blood culture

The T2Candida® Panel demonstrated an overall sensitivity of 94.4% and identified 26 proven infections that were not detected by blood culture.2

Improved stewardship with narrowed, targeted therapy

Negative T2Candida Panel results contributed to the avoidance or de-escalation of antifungal therapy in 64% of these negative patients.

Pharmacy savings

T2 results decreased the average duration of therapy of micafungin by 2.1 days.2​

……………………………………….

1. Edwards J. Oral Presentation, ASM 2017
2. Hassoun A, et al. Utilization of the T2 Candida Panel for rapid Candida species detection in a large community hospital. Poster Presentation, IDWeek 2017

Located inNew Brunswick, New Jersey, Robert Wood Johnson Medical School is an over 750 bed, not-for-profit academic medical center.

The T2Direct Diagnostics™ led to reduced use of antifungals and cost savings at Robert Wood Johnson Hospital: Antifungal therapy was avoided or ceased in 67% of patients with a negative T2Candida result and resulted in cost savings due to reduced use of antifungal drugs.2

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1. Kirn T. Oral Presentation, ASM Microbe, 2017
2. Bhowmick T, et al. Poster Presentation, IDWeek, 2017

Located in Riverside, California, Riverside Community Hospital is an over 470-bed community hospital.

Why T2?

“We are proud to be the first and only acute care hospital in the Inland Empire to invest in this state-of-the-art technology to diagnose sepsis, a very urgent public health issue,” said Patrick Brilliant, president and chief executive officer of Riverside Community Hospital. “We are hopeful that with this technology in our facility, we will see an important change in our ability to diagnose and treat sepsis patients sooner and with the proper medications, ultimately saving lives.”1

Faster Targeted Therapy

83% of patients who tested positive received appropriate therapy within 6 hours of the blood draw and 100% in under 9 hours. 0 patients who tested positive had been on antifungals prior to testing

Reduced use of unnecessary antifungals

Therapy was discontinued for 100% of the patients who tested negative2

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1. Press Release, 2017, Riverside Community Hospital
2. Patel F and Young E. Poster Presentation, IDWeek, 2016
According to the CDC, of the 154 million prescriptions for antibiotics written in doctors’ offices and emergency departments each year, 30% are unnecessary.12

PUBLICATIONS

Over 200 studies published in peer-reviewed journals have featured T2MR in a breadth of applications.