Direct-from-blood multiplex PCR targeting over 95% of sepsis-causing pathogens
Every hour of delayed antibiotic administration increases the risk of death from septic shock by 7.6%
We have developed a molecular diagnostics platform that reduces the turnaround time to identify the pathogen from days to hours
The current standard of care is flawed
Blood culture-based pathogen identification has demonstrated limitations
We know that administering treatment early can save lives in Sepsis, but blood culture has limitations meaning that valuable time is lost waiting for results. This leads to critical patient management decisions being made with "diagnostic blindness."
Resulting in inadequate responses
Studies have shown:
Initial therapy is inadequate for 1 out of 5 septic patients
Overtreatment may be associated with a 20% increase in odds of death
Undertreatment may be associated with a 40% increase in odds of death
Source: Rhee et al. Prevalence of Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated with Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA April 2020
About Safeguard Biosystems
Safeguard Biosystems is a molecular diagnostics platform which has developed a product to identify an extensive menu of the most prevalent bacterial and fungal analytes. Our product identifies the organisms present in a sample, direct from a single 4 ml blood sample, without the need for culture.
Our product uses a proprietary multiplexed PCR that delivers reliable and accurate results within hours directly from a 4 ml whole blood sample, without the need for culture. Compare this to the current 'gold standard' of blood culture which can take at least 1-3 days for a positive culture and up to 5 days for a negative call.
Our system enables physicians rapidly to diagnose the pathogens and prescribe appropriate antimicrobial therapy for singular or poly-microbial infections.
Safeguard’s technology has been validated as a Laboratory Developed Test (LDT) by New York State's Department of Health, and is ISO 13485 certified.
The platform has also been adapted to detect pathogens in dairy cattle directly from milk - ensuring safe dairy food and healthy herds - through the DairyGuard product
Safeguard’s Multiplex Approach – Direct from Blood
Jon Coller, Chief Strategy Officer
Jon Coller joined Safeguard in 2024, having spent 7 years in strategy & operations roles, most recently at McKinsey & Company working strategic issues across growth and commercial optimization in medical devices & public health. Prior to this, he worked at Kraft Heinz developing the alternative protein strategy.
Dr Holger Klapproth, Chief Scientific Officer
Dr Holger Klapproth has over 20 years R&D experience in microarrays and Joined Safeguard in 2007. He also leads the research group at Albert Ludwigs University in Freiburg, Germany. His scientific creativity is demonstrated by the more than 80 patent families he invented or co-invented.
Michael Locke, Head of Regulatory Affairs & Quality Management
Michael Locke has been in the IVD medical device sector for 20+ years, has held senior level management positions, as a Global Director of Regulatory Affairs, Quality Management & Clinical Affairs. Michael is responsible for Regulatory Affairs and Quality Compliance with his extensive experience in global regulations/standards to include MDD/IVDD, MDR/IVDR, US FDA CFR, CMDR/CMDCAS, ISO and UKCA.
Scientific Advisory Board
Dr. Mervyn Singer, Professor of Intensive Care Medicine at University College London. His primary research interests are sepsis and multi-organ failure, infection, shock and haemodynamic monitoring. He is Secretary (formerly Chair) of the International Sepsis Forum and led the ‘Sepsis-3’ international task force that re-defined sepsis in 2016.
Dr. Natan Keller, former Head of Infectious Disease Laboratory, Sheba Medical Center, Israel
Dr. Arthur Rubenstein MBBCh, Professor of Medicine at University of Pennsylvania, and was former Dean of School of Medicine University of Pennsylvania. He was also former Director of LabCorp and Dean of Medicine at the Mount Sinai School of Medicine in NY
Dr. Mel Weinstein, Professor of Pathology & Laboratory Medicine and Co-Director, Microbiology Laboratory at Robert Wood Johnson University Hospital, New Jersey
Fran White, President, Regulatory & Clinical Affairs at MDC Associates. Ms. White is a highly regarded IVD FDA regulatory expert.
Dr. Stephen Young, Director of Research and Clinical Trials at TriCore Reference Laboratories, New Mexico