T2 Biosystems Business Update
October 10, 2024
According to the CDC, antimicrobial resistance is an urgent global public health threat. To address the
threat caused by AMR, the Company has developed the T2Resistance Panel, a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx®
Instrument and simultaneously detects 13 antibiotic resistance genes, in just 3-5 hours, without the need to wait days for a positive blood culture.
In March 2024, the results of a new study were published in Journal of Clinical Microbiology highlighting the benefits of the T2Resistance Panel
compared to blood culture and standard microbiology methods, including high accuracy (i.e., 94.7% sensitivity, 97.4% specificity), rapid turnaround time (i.e., results available is 4.4 hours vs. 58.3 hours), and clinical impact (i.e., clinical
interventions in 41% of patients in the study, or 24 of 59 patients).
LETS MOVE TO THE PLAN TO COMMERCIALIZE THE T2BIOTHREAT PANEL
The T2Biothreat Panel is an FDA-cleared direct-from-blood molecular diagnostic test that runs on the
T2Dx Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax, tularemia, glanders, melioidosis, plague, and typhus.
These six pathogens have been identified as threats by the CDC and, if not treated promptly, can have mortality rates of 40-90%. Our clinical evaluation of the T2Biothreat Panel demonstrated positive percent agreement, or sensitivity, of 100% for all targets except Francisella tularensis, which was 94.3%, and negative
percent agreement, or specificity, of 100% for all six targets.
The National Biodefense Strategy and Implementation Plan includes an objective to
enhance preparedness to save lives through development, testing, evaluation, manufacturing, regulatory approval, distribution, and administration of countermeasures. The T2Biothreat Panel was designed for this purpose, in collaboration
with the U.S. Government, or BARDA, and we expect it to play a role in our nations effort to counter biological threats.
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