LEXINGTON, Mass.—As fall begins, it signals the end to what was a busy—and productive—summer for diagnostic product company T2 Biosystems Inc. The company has reported that in the first half of the year, it signed exclusive distribution agreements with five new partners, which enabled T2 to introduce its rapid diagnostic tests into new markets in Greece, Ireland, Estonia, Saudi Arabia and South Africa, marking 32 countries in which its products are now available outside of the United States.
“Our groundbreaking diagnostic panels rapidly detect sepsis-causing bacterial and fungal pathogens directly from whole blood, providing clinically actionable information that can enable changes in patient outcomes. With rapid results, clinicians can ensure their patients are on early and effective therapy, including the de-escalation of unnecessary therapy, which can help address concerns with antimicrobial resistance and hospital costs,” said John McDonough, president and CEO of T2 Biosystems. “Sepsis represents a major threat to global health, and these new distribution agreements will enable more patients and clinicians to have access to the benefits of T2 technology. We look forward to adding partners in new geographies in the second half of the year and beyond.”
And those new geographies are being added at a fairly steady pace. On Aug. 16, T2 announced a deal that expands the number of countries offering its products to 35, thanks to a distribution agreement that gives it egress into Australia, Fiji and New Zealand. Late last month, the company added yet another agreement that will help it move into Puerto Rico and the U.S. Virgin Islands.
T2 develops rapid, direct-from-blood diagnostics such as the T2Bacteria Panel, T2Candida Panel and T2Resistance Panel. The company’s T2MR technology is capable of identifying five biothreat pathogens, including Bacillus anthracis (anthrax), Burkholderia spp., Rickettsia prowazekii, Francisella tularensis and Yersinia pestis. In addition, the platform can detect these pathogens in whole blood, environmental samples, other biofluids and swab samples. The T2Bacteria Panel is the first and only FDA-cleared test for identifying sepsis-causing bacteria in the blood, and can provide answers in three to five hours. This panel, like others, is run on T2 Biosystems’ T2Dx Instrument, which is powered by miniaturized magnetic resonance (T2MR) technology.
According to McDonough, “The T2Bacteria and T2Candida panels are the first-and-only FDA-cleared tests that can provide direct-from-blood, rapid diagnostics for patients suspected of blood stream infection or sepsis. This patent-protected technological innovation is a major accomplishment, particularly when considering the decades of attempted development efforts from over a half-dozen other companies that did not yield FDA-cleared tests. Since introducing our T2Bacteria Panel at last year’s meeting, we are proud to share that we’ve altered the course of clinical treatment in meaningful ways, making a significant impact on healthcare facilities and the patients they treat.”
Among the data shared at ASM Microbe 2019, T2 noted that meta-analysis of 70 studies has found that 46.5 percent of patients are on the wrong antibiotic therapy regimen with empiric therapy (i.e. no identification of specific bacterial species, a “best guess” approach), while more than 90 percent of patients are on an effective regimen after species identification with tests such as T2Bacteria or T2Candida.
The T2Resistance Panel looks for 13 resistance genes from both gram-positive and gram-negative pathogens in the blood, and initial data has shown that the test can identify such genes in an average of 5.3 hours, compared to an average of 30 hours (and a maximum of 95 hours) with traditional methods. According to the company, this panel is anticipated to be available for research use only in the United States by the end of the year, and to receive CE-mark for commercial availability in Europe in the same time frame.
Dr. Tom Lowery, T2’s chief scientific officer, shared feasibility data at ASM Microbe 2019 that suggests that T2’s T2MR technology could detect more than 250 pathogen species, which covers approximately 99 percent of blood-borne pathogens that cause bloodstream infections and sepsis. In addition, this platform could also have the ability to detect resistance markers for all blood-borne antibiotic resistance threats identified by the U.S. Centers for Disease Control and Prevention.
At the Fifth Annual Biodefense World Summit 2019, Lowery presented data showing that T2Candida auris, for research use only, was able to detect all four known clades of Candida auris in five hours, compared to the 14 days it takes with blood cultures.
T2Bacteria clinical data showed that the diagnostic test could “substantially benefit patients suspected of sepsis in both the emergency department and intensive care unit by providing information that enables significant reductions in time to effective therapy, de-escalation of unnecessary therapy, and avoidance of premature discharges and readmissions to the emergency department.”
“Our unique technology is a proven weapon in the fight against the spread of these dangerous biological agents, providing earlier detection and reducing the unnecessary use of inappropriate antibiotic therapy, which is a driver of drug-resistance in these organisms. We also are excited with the potential to expand our technology for the detection of Candia auris, which is already available as a research-use-only product, and other pathogens that are relevant to the field of biodefense,” said McDonough at the time.