Tailwinds’ Take: further confirmation of the effectiveness of T2’s system. We are highly confident in near-term approval. Even better, many predict slow uptake; we disagree and studies like this demonstrate why we think TTOO will surprise on the upside in terms of sales post approval.
LEXINGTON, Mass., Feb. 09, 2018 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (TTOO), a leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, is announcing the release of two new peer-reviewed publications that demonstrate the superior performance of the T2Candida® Panel over blood culture and the capability of the T2Sepsis Solution™ to enable faster targeted therapy for patients.
In a 14 center study called “DIRECT2,” one of the sites was led by investigators at the University of Pittsburgh Medical Center who published in the journal Clinical Infectious Diseases that strong data demonstrates the T2Candida Panel’s substantial advantages over blood culture for identifying Candida infections. The study also demonstrates the ability of the T2Candida Panel to identify clinically important infections missed by blood culture, while dramatically shortening the time to treat an infection with targeted therapy.
“There are many advantages to quickly diagnosing the specific type of infection a patient has,” said lead author of the DIRECT2 study Cornelius J. Clancy, M.D., associate professor of medicine in the University of Pittsburgh’s Division of Infectious Diseases, and director of the mycology program in a press release. “With an accurate diagnosis, we can start the patient on the correct medication for the type of infection he or she has, which will hopefully allow us to stop the infection before it spreads, but also keep us from giving the patient a drug that won’t work and potentially contributing to drug resistance. For candidemia, we know that the shorter the time to administering an active antifungal medication to a patient, the higher the survival rate.”
The DIRECT2 study finds strong, reliable performance of the T2Candida Panel on real patient samples:
- T2Candida Panel detected 89% of confirmed infections across a large patient population (N=152).
- T2Candida Panel detected almost twice as many confirmed infections as blood culture in patients receiving antifungal therapy. This indicates that the T2Candida Panel is a more effective diagnostic tool for patients treated with pre-emptive or empiric antifungal therapy.
- The median time to detection of Candida by diagnostic blood cultures and subsequent species identification was 3.4 days. In comparison, the T2Candida Panel provides diagnostic results in an average time of 4.4 hours.
In the DIRECT2 paper, the authors conclude that “T2Candida is an important advance in the diagnosis of candidemia. The panel is the first commercial application of T2MR technology in a diagnostic assay and it ushers in a new era in which rapid molecular testing for invasive candidiasis will serve as an adjunct to microbiologic cultures.”
The second study, called “STAMP” and published in the Journal of Clinical Microbiology, compared blood culture to the T2Candida Panel for monitoring the clearance of an infection when a patient is being treated with antifungal drugs. The study demonstrates that the T2Candida Panel can detect the ongoing presence of a Candida infection while blood culture often yields false negative test results because the administration of antifungal drugs can impede the growth of cells that blood culture requires to detect an infection. The authors concluded that the T2Candida Panel can be an effective tool for reliably identifying patients that have cleared an infection, which can reduce the unnecessary and expensive antifungal therapy.
The STAMP study evaluated running multiple diagnostic tests for patients with confirmed Candida infections who were receiving antifungal drugs. The study demonstrated that the T2Candida Panel outperforms blood culture for monitoring the clearance of Candida infections.
- The T2Candida Panel was positive in 23 patient samples, compared to only 7 for blood culture in cases of true infection.
- The T2Candida Panel identified every infection that was detected by blood culture and provided actionable results 3 days earlier than blood culture.
- The T2Candida Panel detected a Candida infection that blood culture missed in 1 patient during the study.
- Two consecutively negative T2Candida Panel results represent a better indicator of clearance of an infection in patients treated with antifungal therapy or where the source of infection was controlled.
- STAMP study data suggest that serial testing of patients with the T2Candida Panel may enable more timely management of infections, de-escalation of therapy, better source control and overall reduced costs of care.
“These studies add to the growing evidence that the T2Candida Panel is superior to blood culture and can be utilized by clinicians to provide both targeted therapy and de-escalation of therapy faster.” said Tom Lowery, Ph.D., chief scientific officer of T2 Biosystems. “The T2Sepsis Solution plays an important role in improving antimicrobial stewardship and improving patient outcomes in hospitals.”
About Candida infections
Candida is one of the deadliest sepsis-causing pathogens with a startling mortality rate of approximately 40 percent. It is one of the leading hospital-acquired bloodstream infections in the United States and half of Candida infections are misdiagnosed as being negative by blood culture. The patient and economic impacts of Candida are tremendous: patients average 40 days in the hospital at a cost of $130,000. Studies have shown that every hour of delayed treatment increases the risk of mortality by nearly eight percent. Blood culture-based diagnostic tests, which are the current standard of care, typically require one to six or more days to deliver a result as compared to the T2Candida Panel that provides accurate results in an average of 3 to 5 hours.
About T2 Biosystems
T2 Biosystems, a leader in the field of innovative medical diagnostics that solves critical unmet needs in healthcare, improves patient care and reduces the cost of healthcare by helping clinicians effectively treat patients faster than ever before. For more information, please visit www.t2biosystems.com.
About the T2Sepsis Solution
Sepsis, one of the deadliest and most expensive conditions in hospitals today, is the focus of the T2Sepsis Solution, a unique approach that combines the standard of care for the management of sepsis patients with T2 Biosystems’ products, including the T2Dx® Instrument and T2Candida Panel, and the T2Bacteria® Panel. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. It 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. T2Bacteria Panel is commercially available in Europe and other countries that accept the CE Mark and is available for research use only in the U.S.
Amy Phillips, Feinstein Kean Healthcare
Chris Brinzey, Westwicke Partners
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