Multiple New Studies Demonstrate T2 Biosystems’ Diagnostics Improve Detection of Sepsis Causing Pathogens Over Blood Culture-based Diagnostics

LEXINGTON, Mass., March 28, 2018 --

T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development and commercialization of innovative medical diagnostic products, announces the publication of four new, peer-reviewed studies that demonstrate the clinical and performance advantages of the T2Dx^® Instrument over blood culture. The T2Dx Instrument runs the T2Candida^® and T2Bacteria^® Panels, which detect and identify pathogens that cause sepsis. Sepsis is a life-threatening illness that kills 250,000 Americans and an estimated 6 million people globally each year, and is the most expensive hospital-treated condition in the U.S., with costs exceeding $27 billion. The studies were conducted in the United States and Europe and all published today in the Journal of Antimicrobial Chemotherapy.

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

• Positive results more than 4.5 times faster: Positive results for a bacterial infection with T2Bacteria were available in 5.5 hours, compared to a mean time of 25 hours for blood culture. Every hour of providing targeted therapy to patients faster can reduce patient mortality rates by 7.6%.
• Negative results 20 times faster: A negative result took 120 hours (5 days) for blood culture, compared to 6.1 hours with the T2Bacteria Panel.  
• Excellent accuracy: The T2Bacteria Panel had 89.5% sensitivity and 98.4% specificity in comparison with clinical criterion of a true infection. The authors point out that blood culture-based diagnostics have a sensitivity as low as 65% for the first blood culture draw.
• Potential impact on therapy: The authors found that 66.7% of the clinically infected patients missed by blood culture and correctly identified by T2Bacteria were being inappropriately treated at the time of the T2Bacteria result.

“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 Maurizio Sanguinetti, M.D., 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: 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: Due to the more targeted use of antifungal drugs, the average duration of antifungal therapy with T2Dx testing was reduced by 4 days and therapy was discontinued after a single dose or avoided altogether in 58.4% of patients, leading to significant pharmacy savings and with no adverse impact on patient mortality. The authors estimate savings in antifungal costs after T2Candida testing was introduced at an average of $280 per patient tested.

Finally, two studies from Gregorio Marañón Hospital in Madrid, Spain 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 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.” 

About Sepsis
Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs exceeding $27 billion. Sepsis claims more lives annually than breast cancer, prostate cancer, and AIDS combined and is the #1 most prevalent and costly cause of hospital readmissions. The pathogens that cause sepsis infections are difficult to detect and can be deadly even at very small concentrations in the bloodstream. With sepsis, one hour of delayed treatment increases mortality risk by nearly 8%.

About T2 Biosystems
T2 Biosystems, an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, improves patient care and reduces the cost of healthcare by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx Instrument, T2Candida Panel, and the T2Bacteria Panel and are powered by the proprietary T2 Magnetic Resonance technology, or T2MR^®. 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. For more information, please visit www.t2biosystems.com.

Contact information:

Media Contact:
Amy Phillips, Feinstein Kean Healthcare
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412-327-9499

Investor Contact:
Chris Brinzey, Westwicke Partners
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339-970-2843