Theranostics: Combining unique diagnostics followed by a targeted therapy
Sepsis affects approximately 1,000,000 patients in the U.S. alone each year and millions worldwide. The ability to rapidly and accurately diagnose and treat this deadly disease remains one of the biggest challenges faced by healthcare professionals today. Using a unique and innovative theranostics approach, Spectral Diagnostics is committed to decreasing the unacceptably high mortality rates caused by sepsis. By combining complementary diagnostics and therapeutics, or theranostics, Spectral’s vision is to provide products that will enable vastly improved outcomes of patients with severe sepsis.
It is widely known that endotoxin is a trigger of sepsis. As leaders in the area of endotoxin and its role in sepsis, Spectral is currently conducting a Phase III clinical trial for its lead product, Toraymyxin, for the treatment of patients with septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes circulating endotoxin from the bloodstream, which may result in a significant reduction in mortality. Subjects will be selected based on clinical criteria for septic shock and are categorized as endotoxemic based on the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the measurement of endotoxin. This is the first time that a theranostic approach, the combination of a diagnostic followed by a targeted therapy, will be used in the area of clinical trials for sepsis. The EUPHRATES pivotal trial, (Evaluating Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) plans enrollment of approximately 360 subjects at 50 sites throughout the U.S. and Canada. An interim analysis of data for the trial is targeted when enrollment reaches 184 subjects.
Spectral strives to exceed the highest ethical, financial and scientific standards in all our operations and activities. By maintaining excellent relationships within the clinical community, as well as with customers and business partners, Spectral aims to win the battle against sepsis mortality with the first ever theranostic – EAA™ and Toraymyxin.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI and the OTCQX under the symbol DIAGF.
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