Selux Diagnostics, Inc. 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).
Funding supports commercialization after recent completion of clinical trial and FDA submission |
[19-October-2021] |
BOSTON, Oct. 19, 2021 /PRNewswire/ -- 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 Caution - The Selux platform is an investigational device, limited by federal law to investigational use Acknowledgment About Selux Diagnostics CONTACT: “Selux’s Next-Generation Phenotyping (NGP) platform uniquely holds the potential to transform patient care and combat the antibiotic resistance epidemic. by enabling personalized antimicrobial therapies to be administered to patients within a day, cutting 2+ days off the current treatment paradigm,” said Steve Lufkin, CEO of Selux. View original content to download multimedia:https://www.prnewswire.com/news-releases/selux-diagnostics-awarded-2-8-million-grant-from-nih-for-commercialization-of-its-ngp-platform-301403109.html SOURCE Selux Diagnostics, Inc. |