Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance, today announced that it 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,” said 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.”
The NIH grant comes on the heels of several key milestones achieved by Selux. 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 breakthrough NGP technology works for all sample types and utilizes phenotypic AST — the only method that provides full actionable results indicating which therapies will effectively treat a patient’s infection.
With a comprehensive antibiotic menu that far surpasses the capabilities of current legacy AST systems, NGP can provide accurate, same-shift results for up to 50 antibiotics simultaneously. As a result, physicians can prescribe optimal treatment 3-5 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,” said Lufkin. “The NGP transformation is most significant for multi drug resistant (MDR) infections, which currently require 4+ 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.”
About the Selux Next-Generation Phenotyping Platform
The proprietary Selux technology uniquely provides targeted therapy results days faster than the current standard of care providing actionable information to inform patient treatment for all Infectious Diseases. Selux’s NGP platform provides unprecedented speed-to-results and breadth of menu while meeting the accuracy, throughput, and cost effectiveness requirements of clinical microbiology laboratories and integrated healthcare systems.
Caution – The Selux platform is an investigational device, limited by federal law to investigational use
Acknowledgment
This platform has been funded in whole or part with federal funds from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201800013C.
About Selux Diagnostics
Selux Diagnostics is transforming patient care by offering <24-hour personalized antimicrobial therapy results for all Infectious Diseases patients. This advance will save lives, shorten hospital stays, and combat the growing antibiotic resistance epidemic by decreasing the overuse of broad-spectrum agents. The 5-year-old company is based on the opposite side of Boston, MA, from where it originated in a co-founder’s attic. Learn more at www.seluxdx.com.
