BOSTON—Selux Diagnostics Inc. recently announced the award of an additional $9.6 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Selux plans to use the funding to advance the development of its Next-Generation Phenotyping (NGP) technology, a rapid and precise antimicrobial susceptibility test (AST), through clinical trials.
“Selux’s Next-Generation Phenotyping platform offers uncompromised accuracy, an unprecedented speed-to-results and breadth of antibiotic menu, and it does so without sacrificing performance. It provides AST results within a clinically relevant time, so clinicians have access during a patient’s most critical phase ... clinicians can now treat a patient’s infection with a personalized antibiotics regimen in one day,” Steve Lufkin, CEO of Selux Diagnostics, tells DDN. “Effectively, when the ID becomes available, the clinicians will simultaneously receive the AST results—whether from an isolated colony or from a positive blood culture.”
“The Selux NGP platform delivers the capability of identifying which personalized antibiotics will effectively treat a patient’s infection—and it does so one to four days faster than the current standard of care. It fully meets all accuracy, throughput and cost effectiveness requirements of clinical microbiology laboratories and integrated healthcare systems,” Lufkin adds. “The platform provides a menu of 60+ antibiotics per sample—five times more antibiotics than current AST technology—and, due to its ready expansion room, will seamlessly incorporate newly approved drugs. [It] will transform infectious disease patient care by expediting cures, improving patient outcomes, and reducing hospital stays and hospital-acquired infections. Truly transforming the way we prescribe and treat infectious disease patients requires that we improve AST diagnostics.”
The $9.6-million award is the third funding tranche Selux has received from BARDA as part of the company's milestone-based contract, which is worth up to $45 million. Selux has received $30.4 million in funding to date.
“BARDA has offered strong support in the development of the Selux NGP platform, and has led the way in the successful government-private sector collaboration to solve one of the world’s toughest health challenges—antibiotic resistance,” noted Lufkin. “This leadership is especially vital now, as new data indicate the antibiotic resistance crisis is even more threatening than previously understood.”
“Although of course impacted by the COVID environment, we are currently in clinical trials and we recognize those are more critical now, considering we have patients dying of secondary infections,” says Lufkin. “We have high expectations for success. Upon finishing clinical trials, we will proceed with commercialization to bring the technology to market for use in hospitals and health systems. We are advancing as quickly as possible with the full support of BARDA and our private investors, who recognize Selux’s potential to transform infectious disease patient care and combat the global crisis of antibiotic resistance.”
In November 2019, the Centers for Disease Control (CDC) released “Antibiotic Resistance Threats in the United States,” a study which found that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and 35,000 deaths in the U.S. every year. The study discovered that the mounting global threat of antibiotic resistance is much worse than previously known, with new data revealing that there have been “nearly twice as many annual deaths from antibiotic-resistant infections as CDC originally reported in 2013.” Experts predict that without a major change in today’s treatment paradigm, deaths from superbugs will surpass deaths from cancer by 2050.
“I think it’s exciting that we may be on our way to addressing the global crisis in antimicrobial resistance. Between a recent new study revealing the global antibiotic resistance crisis is much worse than we thought, and the secondary bacterial infections we are seeing caused by COVID-19, efforts to drive AST innovation are more urgent than ever. I think people are starting to understand that we must preserve the efficacy of broad-spectrum antibiotics by shifting toward personalized antibiotic therapies,” Lufkin concludes. “Assuming success of our current NGP platform through clinical trials, we are excited to look ahead to research a new rapid, high-throughput, low-cost, patient-centered blood culture method.”