T2 Biosystems Presents Data on T2Bacteria Panel for Sepsis Prevention Opportunities at ASM

T2 Biosystems, Inc., an emerging leader in the development of innovative diagnostic products for critical unmet needs in healthcare, announced late-breaker posters and data presented at the American Society for Microbiology (ASM) Microbe conference on June 7-11 that demonstrate the T2Bacteria® Panel’s accuracy and speed, which may enable more rapid treatment of patients with bloodstream infections in order to prevent sepsis. FDA clearance of the T2Bacteria Panel was announced on May 29, 2018, making the T2Bacteria Panel the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood.

“The strong customer data and conclusions expressed by clinicians at ASM Microbe on T2Bacteria are encouraging and allows us to further strengthen the momentum generated by FDA clearance two weeks ago,” said John McDonough, president and chief executive officer, T2 Biosystems. “We are already seeing excitement in the market, as healthcare providers recognize the potential of the T2Bacteria Panel to prevent the progression of bloodstream infections to sepsis. The ASM Microbe conference, which is one of our largest customer meetings of the year, was an important and successful step to raise awareness around the T2Bacteria Panel.”

For the first time in the U.S., the T2Bacteria pivotal clinical trial data was presented, representing a large study of over 1,400 patient samples collected across 11 hospital and hospital systems across the U.S. The investigators concluded:

• T2Bacteria demonstrated excellent accuracy, including overall sensitivity of 90% and overall average specificity of 98%.
• T2Bacteria detected 69 patient infections that were not detected by the concurrent blood culture.
• Blood culture species identification results took an average of 3 days while T2Bacteria took an average of only 5.4 hours in the clinical trial, providing results more than 2.5 days faster.
• 66% of patients in the clinical trial with a bloodstream infection confirmed by T2 and blood culture could have benefited from earlier appropriate antibiotics based on the rapid T2Bacteria result.
• T2Bacteria also had a noted advantage in detecting infected patients on antibiotics who were missed by blood culture.

“T2 panels afford clinicians the first direct from blood diagnostics for the detection of sepsis-causing pathogens,” said clinical trial investigator Cornelius J. Clancy, MD, Associate Professor of Medicine, Infectious Diseases Division and Director, Mycology Program, University of Pittsburgh; Chief of Infectious Diseases Section, VA Pittsburgh Health Care System. “Earlier species ID results from T2Bacteria and T2Candida provide critical and timely information that can aid in providing the best care for my patients. The T2Bacteria pivotal clinical trial data corroborate findings from the T2Candida Direct2 study by demonstrating the limitations of blood culture and the potential impact of the T2 platform.”

A separate evaluation of T2Bacteria by clinicians at Ochsner Medical Center found:

• T2Bacteria detected 14 infections missed by a paired blood culture – but proven to be a true infection by other cultures.
• T2Bacteria identified every infection detected by blood culture of the target species (100% sensitivity).
• T2Bacteria was highly accurate in identifying samples without an infection, with 99% average specificity.

The authors concluded that the advantages of T2Bacteria over blood culture could make it a valuable tool to enable faster time to targeted antibiotic therapy and reduced use of unnecessary antibiotics.

In a late-breaker poster from Northwestern University, clinicians found the T2Bacteria Panel was highly accurate compared to blood culture and detected 18 clinically important urinary and respiratory infections that were missed by blood culture. The authors concluded that T2Bacteria may improve patient care by providing clinicians rapid and actionable information for treating patients.

Finally, another late-breaker poster from the Centers for Disease Control and Prevention (CDC) on their validation of the Research Use Only diagnostic for the detection of the emerging superbug Candida auris, found that the T2 Magnetic Resonance (T2MR®) provided extremely accurate diagnostic results from patient skin samples. The poster concludes that T2MR could be used to provide a more rapid response to future outbreaks.