New data shows use of T2 Biosystem’s diagnostic panel for rapid detection of sepsis, caused by Candida, could save hospitals millions of dollars annually

With sepsis claiming 500,000 lives1 in the U.S. each year and costing hospitals and healthcare systems more than $23.7 billion,2 healthcare organizations are looking for ways to provide better and faster care to their patients while controlling costs.

Many studies have demonstrated that patient mortality from sepsis is reduced by 8% for every hour the timing of administration of the appropriate drug is accelerated and that the average hospitalization cost per patient can be reduced by over $20,000 when targeted therapy is administered within the 24 hours immediately following the onset of symptoms. For decades, the industry has sought ways to more rapidly and accurately diagnose patients with hospital acquired bloodstream infections so physicians can more quickly initiate appropriate treatment.

Among the most common sepsis-causing pathogens is the yeast pathogen Candida, which can lead to severe complications and even death if not treated rapidly. Candida is typically detected with a blood culture that can take up to 6 days to provide results.3 However, a new technology – developed by T2 Biosystems – that does not require a blood culture can provide accurate results in an average of 4.3 hours,4 enabling physicians to quickly initiate appropriate therapy or discontinue unnecessary anti-microbial therapy.

Now, new data from 4 U.S. hospitals provide evidence that this sepsis pathogen detection panel, called the T2Candida® Panel, can significantly reduce healthcare costs. Highlights include the reduction in time to appropriate therapy of 34 hours, the reduction in average patient ICU length of stay of 7 days and gross pharmacy savings of $400-500 per patient.5,6,7 This article explains how the T2Candida® Panel can help deliver meaningful improvements in patient outcomes and improve hospital financial results, including one hospital where over $2 million in annualized cost savings were realized in 6 months from 55 candidemic patients.

Candida infections costly to treat
Candida is the fourth leading hospital-acquired bloodstream infection,8 responsible for more than 135,000 cases per year.9 It is also the most lethal,10 with a 40 percent mortality rate.11 Patients with a weakened immune system (i.e., those undergoing cancer treatment, those receiving immunosuppressive therapy following an organ transplant, and severely ill patients in intensive care units) are at highest risk.12 Patients with a Candida infection typically spend an average of 40 days in the hospital 13, including nine days in intensive care,14 resulting in an average cost per hospital stay of $130,000 per patient.15

Hospital labs typically use a blood culture to detect Candida and identify the type of species, but blood culture has several limitations. Not only does blood culture typically take 2 to 6 days for species identification or a negative result, but it has a low sensitivity, missing 40 to 50 percent of infections.16 While waiting for blood-culture-based diagnostic results many hospitals initiate antifungal treatment empirically. An estimated 40 percent of high-risk symptomatic patients are on this empiric therapy for 1 to 15 days regardless of whether they have a Candida infection.17

 

Early detection is critical
In patients with sepsis, a timely diagnosis is critical as each hour of delayed treatment increases the risk of mortality by 8 percent.18 Candida mortality can be reduced from 40 percent to 11 percent if patients are treated with appropriate antifungal therapy within 12 hours of showing symptoms.19,20 A study published in the American Journal of Respiratory and Critical Care Medicine found that providing targeted antifungal therapy within 24 hours of the presentation of symptoms decreased the length of hospital stay by approximately 9 days21 and decreased the average cost of care by approximately $30,000 per patient.22

High specificity and sensitivity of T2Candida Panel
In 2014, the U.S. Food and Drug Administration cleared the T2Candida® Panel, becoming the first diagnostic to detect five clinically-relevant species of Candida directly from whole blood with no blood culture: C. albicans, C. tropicalis, C. parapsilosis, C. krusei and C. glabrata. The T2Candida® Panel works by breaking apart the Candida cells, releasing the DNA, making numerous copies of the target DNA, and detecting the amplified DNA using magnetic resonance technology, all without purifying the target from the blood sample. In the pivotal clinical trial, the T2Candida® Panel demonstrated a specificity of 99.4 percent and a sensitivity of 91.1 percent.23

Real-world financial impact of T2Candida Panel in hospital setting
Findings from studies recently conducted at 4 U.S. hospitals, or hospital systems of varying size, have demonstrated that the use of the T2Candida Panel for rapid sepsis-causing pathogen detection can reduce the healthcare costs associated with Candida infection by helping medical professionals make targeted treatment decisions earlier. The data were presented during the Infectious Diseases Society of America's (IDSA) IDWeek 2016.

Henry Ford Hospital
At Henry Ford Hospital, a large, Level 1 trauma hospital in Detroit, 142 patients were diagnosed with candidemia (Candida in the bloodstream) by the T2Candida® Panel, Beta-D glucan or blood cultures. 55 of those patients were detected with T2Candida. Compared to a prior cohort of patients diagnosed with just Beta-D glucan or blood culture, results showed that the use of the T2Candida Panel significantly improved the management of these patients and resulted in cost savings. Data highlights from this large study are statistically significant and include the following:
• Reduced the average time to Candida species identification by 16.5 hours (p=0.01)
• Reduced the average time to appropriate antifungal therapy by 13 hours (p=0.01)
• Reduced the median ICU length of stay (LOS) per patient by 7 days (p=0.009)
• Showed a trend in reducing total LOS by 4 days per patient (p=0.164)
• Resulted in a projected $2.3 million in total cost savings annually based on the actual LOS data

Lee Health System
The Lee Health System in Florida, the fourth largest public healthcare system in the U.S., conducted a 182-patient study, where 7 tested positive for Candida with the T2Candida® Panel. Results showed that early detection of Candida with the T2Candida® Panel enabled early, administration of the appropriate therapy. Data highlights include the following:
• T2Candida reduced average time to appropriate antifungal therapy by 34 hours (previously, time to appropriate therapy averaged 40 hours; with the T2Candida Panel, investigators reported an average of six hours)
• Unnecessary antifungal therapy was avoided in 41 percent of patients
• Unnecessary antifungal therapy was discontinued after 1 dose in another 15 percent of patients
• LOS reduction by an average of 7 days (13 days in post-T2Candida Panel test cohort vs 20 days in Candidemic patients in pre-T2Candida Panel group)
• Average antifungal savings of approximately $400 for every patient where antifungal use was reduced or eliminated.

Riverside Hospital
At Riverside Hospital, a 373-bed community hospital in Riverside, California, 59 at-risk patients were tested with the T2Candida Panel; 6 were positive and 53 were negative. Results showed that early detection of Candida with the T2Candida Panel allowed early, appropriate antifungal therapy. Data highlights include the following:
• Results were available in the hospital reporting system in an average of 6.3 hours
• 83 percent of patients who tested positive received appropriate therapy within 6 hours of the blood draw and 100 percent in under nine hours
• None of the 6 patients who tested positive had been an on an antifungal prior to testing
• Of the 8 patients with a negative result who had been on antifungal therapy, the therapy was discontinued.

Huntsville Hospital
At Huntsville Hospital, a 941-bed community hospital in Huntsville, Alabama, 160 patients at risk for invasive candidiasis were tested with the T2Candida Panel and results were compared with blood culture results. Results showed that the T2Candida Panel demonstrated superior sensitivity to blood cultures and provided a much faster time to antifungal treatment modification, resulting in cost savings. Data highlights include the following:
• The T2Candida Panel detected and identified 56 percent more positive patients than blood culture.
• For patients with a negative T2Candida Panel result, the average duration of antifungal therapy was 4 days, and the average time to de-escalate unnecessary treatment was 42.6 hours
• The reduction in Duration of Therapy and time to de-escalation in negative patients equated to gross pharmacy savings of about $500 per patient

Candida infections place a tremendous burden on the healthcare system, costing hospitals $130,000 per candidemic patient24 to care for these patients. In an effort to save lives and reduce costs, hospital executives are focused on identifying new technologies to detect Candida infection that are faster, easier to use and provide earlier, more accurate results. The T2Candida Panel delivers results in an average of 4.3 hours 25; with blood cultures, physicians spend days waiting for results. By providing rapid positive results, the T2Candida Panel enables clinicians to start specific, effective antifungal treatment as early as possible, which reduces costs, adverse outcomes and mortality rates. By providing rapid negative results, the test potentially can help clinicians avoid or discontinue unnecessary antifungal treatment, which reduces toxicity to the patient, lowers the risk of antimicrobial resistance in the hospital, and lowers antimicrobial costs. Now, with the results of the 4 recent in-hospital studies, there is new evidence showing that this improved diagnostic provides a strong economic return for hospitals.

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About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

Bio for Tom Lowery, Ph.D.
Dr. Tom Lowery is chief scientific officer for T2 Biosystems, a company in Lexington, Mass., that is developing innovative diagnostic products to improve patient health. He joined the company in 2007 and has held various technical leadership roles for assay, methods, reagents and detector development programs. Prior to joining T2 Biosystems, Dr. Lowery conducted research at the University of California, Berkeley, focused on developing magnetic resonance-based biosensors for molecular imaging. That work was funded by the UC Graduate Research and Education in Adaptive Biotechnology program. He has 49 issued or pending patents and has authored numerous articles and book chapters. His articles and research papers have been published in Science, Clinical Chemistry, Protein Science, Blood, Science Translational Medicine, the Proceedings of the National Academies of Sciences USA and Journal of the American Chemical Society. He graduated Summa Cum Laude with a B.S. in biochemistry and University Honors from Brigham Young University. He earned a Ph.D. in chemistry from the University of California, Berkeley.

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