Multiple studies show potential of T2’s diagnostics

LEXINGTON, Mass.—T2 Biosystems Inc., an emerging player in the development and commercialization of innovative medical diagnostic products, announced this spring the publication of four new, peer-reviewed studies that demonstrate the clinical and performance advantages of the T2Dx Instrument over blood culture.

T2Dx runs the T2Candida and T2Bacteria Panels, which detect and identify pathogens that cause sepsis, a life-threatening illness that kills 250,000 Americans and an estimated 6 million people globally each yea—it is the most expensive hospital-treated condition in the United States, with costs exceeding $27 billion.

A study conducted at Gemelli Hospital in Rome reported several highlights regarding usage of the T2Bacteria Panel on the T2Dx Instrument:

• Positive results more than 4.5 times faster—5.5 hours compared to a mean time of 25 hours for blood culture.

• Negative results 20 times faster—6.1 hours with the T2Bacteria Panel vs. 120 hours (5 days) for blood culture.

• Accuracy—T2Bacteria Panel had 89.5 percent sensitivity and 98.4 percent specificity

“Our study demonstrates that the T2Bacteria Panel has the speed and accuracy to detect deadly, sepsis-causing infections, leading to more targeted therapy for patients and improved stewardship for the hospital,” said Dr. Maurizio Sanguinetti of Gemelli Hospital. “T2Bacteria is a very important advance in the fight against sepsis, and we are excited to be among the first hospitals to demonstrate its value.”

A study conducted at Lee Health in Florida found:

• The T2Dx enables patients to receive targeted therapy 28 hours faster.

• Due to the more targeted use of antifungal drugs, the average duration of antifungal therapy with T2Dx testing was reduced by four days and therapy was discontinued after a single dose or avoided altogether in 58.4 percent of patients.

Finally, two studies from Gregorio Marañón Hospital in Madrid reported findings about the ability of the T2Candida Panel to predict patient outcomes:

• Strong indicator of complications—Positive T2Candida Panel results identified patients who had an over 30 times 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 percent of patients.

• Improved distinction—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,” said Dr. Patricia Muñoz of the Division of Clinical Microbiology and Infectious Diseases at Hospital General Universitario Gregorio Marañón. “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.”