T2 Biosystems, a company developing innovative diagnostic products to improve patient health, has announced that results from its pivotal trial evaluating its lead products, the T2Candida® Panel and the T2Dx® Instrument were published online in the journal Clinical Infectious Diseases (CID). The results will also appear in a forthcoming print issue of the journal.
T2Candida and T2Dx were cleared for use by the U.S. Food and Drug Administration (FDA) on September 22, 2014, for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. Candida is the most lethal form of common blood stream infections that cause sepsis, a potentially life-threatening illness in which the body has a severe, inflammatory response to a bacterial or fungal infection. T2Candida and T2Dx are designed to detect Candida species directly from a whole blood specimen in three to five hours, providing a fast, sensitive and simple alternative to existing diagnostic methodologies, including blood culture, which can take up to six days or more to deliver results. T2Candida and T2Dx are the first diagnostic products powered by T2MR®, an innovative and proprietary magnetic resonance-based diagnostic technology platform that does not require blood culture and sample purification or preparation.
“The ability to determine the presence or absence of Candida within hours – compared to days – is paradigm changing for patients at risk for these infections,” said Eleftherios Mylonakis, M.D., Ph.D., FIDSA, Chief, Division of Infectious Diseases, Rhode Island Hospital and The Miriam Hospital and Dean’s Professor of Medical Science, Alpert Medical School of Brown University, Providence, RI, and lead author of the study. “It will allow us to move from a ‘best-guess’ approach in treating high-risk patients, such as cancer and transplant patients and patients in the Intensive Care Unit, to a more informed approach where we can quickly direct the best course of therapy potentially improving patient outcomes and saving lives.”
Key Study Findings
This multi-center study enrolled and collected blood specimens from 1,801 hospitalized patients between ages 18 and 95 years old who had a blood culture ordered as part of routine care. In the pivotal trial, T2Candida and T2Dx demonstrated:
- Overall sensitivity of 91.1%
- Overall specificity of 99.4%
- The mean time to positive result for T2Candida was 4.4 hours, compared to 129 hours for blood culture and species identification.
- The mean time to negative result for T2Candida was 4.2 hours, compared to at least 120 hours for blood culture.
In one case described in the paper, T2Candida detected a Candida infection that blood culture missed in 12 successive tests. Seven days after the T2Candida result was obtained, physicians performed an invasive procedure to obtain a tissue culture, which proved that the T2Candida result accurately identified a case of intra-abdominal candidiasis, a strain of Candida.
Cornelius J. Clancy, an investigator in the study who presented this case at IDWeek 2014, stated, “Blood culture, the current standard of care for the diagnosis of Candida infections, is known to have poor sensitivity overall and has 38% sensitivity in proven and probable cases of invasive candidiasis. In our case, the T2Candida Panel has shown that it can rapidly identify intra-abdominal candidiasis where twelve serial blood culture results were negative. In many patients at risk for candidiasis, the collection of tissue samples for diagnosis is not possible due to their underlying medical conditions. Achieving the level of sensitivity demonstrated in this case, without requiring an intra-abdominal sample, has the potential to positively impact the practice of medicine for these patients.”
“Candida represents a significant public health issue; the average patient spends approximately 40 days in the hospital at a cost of approximately $130,000 per patient, and mortality rates have remained high and unchanged for the past two decades,” said John McDonough, president and CEO of T2 Biosystems. “With T2Candida and T2Dx, we have the opportunity to make a significant impact on the way physicians are able to diagnose and treat this condition – potentially reducing costs, length of stay and mortality rates, while also potentially eliminating the use of harsh antifungal medicines that are unnecessarily administered to patients awaiting blood culture results. We are encouraged by the publication of these peer-reviewed data and enthusiastic about the opportunity for T2MR to make an important impact on the management and prognosis of this disease.”
Pure Communications Inc.