Selux Diagnostics Inc., which specializes in personalized diagnostics to combat superbug infections and fight antibiotic resistance, has received a $2.8 million award from the U.S. National Institutes of Health (NIH) to help the company commercialize its Next Generation Phenotyping (NGP) platform for rapid antimicrobial susceptibility testing (AST). Having recently completed its first clinical trial and submitted the results to the U.S. Food and Drug Administration (FDA), Selux will use the NIH grant to fund three projects that advance the commercial readiness of the Selux NGP platform.

“Selux NGP is the only single-platform technology capable of delivering rapid AST results across a broad antibiotic menu for all sample types,” says Steve Lufkin, CEO of Selux. “By providing funding for Selux to scale manufacturing to lower costs and perform a multi-center study to compare NGP performance against legacy systems, this NIH funding will help Selux transform patient care for infectious diseases by positioning NGP as the dominant AST platform of the future.”

Last month, Selux received Breakthrough Device Designation from the FDA for positive blood culture and sterile body fluid sample indications for NGP. The Breakthrough Devices Program provides patients and providers with timely access to medical devices by speeding up their development, assessment, and review process while preserving statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. In June, Selux submitted the results of its first clinical trial to the FDA for 510(k) clearance.

Selux’s NGP technology is designed to work for all sample types and uses phenotypic AST—the only method that provides full actionable results indicating which therapies will effectively treat a patient’s infection, according to the company.

With a comprehensive antibiotic menu, NGP is designed to provide accurate, same-shift results for up to 50 antibiotics simultaneously. According to the company, this allows physicians to prescribe optimal treatment three to five days sooner, reducing hospital stays and de-escalating the cycle of antibiotic overuse and resistance.

“Selux’s NGP platform uniquely holds the potential to transform infectious diseases patient care and combat the antibiotic resistance epidemic by enabling personalized antimicrobial therapies to be administered to patients within one day,” Lufkin says. “The NGP transformation is most significant for multi-drug resistant (MDR) infections, which currently require four-plus days before AST results are available. The Selux platform quadruples the number of antibiotics tested in parallel for each sample over legacy AST platforms, thereby providing rapid results for MDR-infected patients.”

For more information, visit Selux.

Featured Image: Selux’s Next Generation Phenotyping (NGP) platform for rapid antimicrobial susceptibility testing (AST) is in the process of being commercialized thanks, in part, to a grant from the NIH. Photo: Selux Diagnostics