GNOMX Corp. Awarded Phase 1 BARDA DRIVe Contract to Develop Immune Dysregulation Host-based Assay for Predicting Sepsis Patient Readmission Risk

Newswise — GNOMX Corp. has been awarded a $749,700 contract by the Division of Research, Innovation, and Ventures (DRIVe) within the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) of the U.S. Department of Health and Human Services. The contract will support the development of an immune dysregulation host-based assay on a CLIA lab-compatible PCR instrument to predict risk of post-discharge deterioration and hospitalization readmission of sepsis patients. 

The contract was awarded under BARDA DRIVe’s Host-Based Diagnostics program that focuses on developing diagnostic tools that harness a patient’s systemic response to infection to inform on clinical outcome and help guide patient management. Sepsis, the body’s extreme reaction to an infection, represents the overall most costly diagnosis in the United States health care system, being responsible for an estimated $62 billion in hospitalization costs in 2021. Approximately 1.7 million people in the US develop sepsis annually resulting in 350,000 deaths. According to an article published in the American Journal of Critical Care1 an estimated 24% of sepsis patients are readmitted to the hospital within 30 days of being discharged.1   The inability to predict and prevent these largely unreimbursed readmissions adversely impacts patient outcomes and creates a major financial burden for hospital systems. 

“Under the BARDA DRIVe contract, GNOMX will be applying our proprietary epigenetic/AI technology to address this gap,” said J. Mark Junewicz, CEO and co-founder of GNOMX.  “We look forward to commencing work on this groundbreaking technology to reduce sepsis patient hospital readmissions, improving patient outcomes and reducing health care costs.” 

“GNOMX’s technology, through this BARDA DRIVe contract, will help bring this needed assay into the clinic, with the goals of improving patient outcomes, reducing hospital readmissions, and decreasing hospital expenses,” said co-founder Stuart Sealfon, MD, Sarah B. and Seth M. Glickenhaus Professor and Chair Emeritus of the Department of Neurology, and Director of the Center for Translational Systems Biology at the Icahn School of Medicine at Mount Sinai, and GNOMX Chief Scientific Officer and Scientific Founder. Dr. Sealfon emphasized that “sepsis readmissions are costly to hospitals because they can reduce their reimbursement rates.” 

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50124C00038. 

GNOMX epigenetic diagnostic platform includes technology developed by Mount Sinai faculty and was optioned by Mount Sinai to GNOMX. Mount Sinai and Mount Sinai faculty, including Dr. Sealfon, have a financial interest in this technology and in GNOMX pursuant to the Mount Sinai Intellectual Property Policy. Mount Sinai is represented on the GNOMX Board of Directors by Felipe Araujo, PhD, Managing Director of Business Development and Licensing within Mount Sinai Innovation Partners. 

About GNOMX 

GNOMX Corp. (“GNOMX” or the “Company”) was founded in New York, NY in October 2022 to translate capabilities developed through $46 million of foundational research supported by the Defense Advanced Research Projects Administration (DARPA) into a new generation of innovative blood tests for infectious disease and other conditions. The Company’s core technologies are exclusively licensed from a research consortium led by the Icahn School of Medicine at Mount Sinai, including Princeton University, Yale School of Medicine, and University of Pittsburgh School of Medicine. GNOMX’s mission is to provide earlier, more accurate infectious disease diagnostics, prognosis and treatment guidance, and reduce misdiagnosis, unnecessary testing, morbidity, mortality, and care costs. 

GNOMX’s technology is capable of providing specific infection diagnosis (including time since infection), multiple target diagnosis, and antibiotic sensitivity. The Company’s test development engine also requires reduced sample numbers for new test development. GNOMX has developed proof-of-principle data with greater than clinical grade accuracy for Long COVID, acute Lyme disease and sepsis. All are huge unmet medical needs with no currently reliable diagnostics. Discussions are underway with established test providers to implement the Company’s tests and accelerate regulatory approval and market entry. 

¹ American Journal of Critical Care (Volume 33, Issue 5 September 1, 2024