European and U.S. Patent Allowances Strengthen Immunexpress' Leading Position in Host-Response Sepsis Diagnostics
SEATTLE, Sept. 24, 2018 /PRNewswire/ -- Immunexpress, Inc., today announced the receipt of 'Notices of Allowance' from both the U.S. Patent and Trademark Office (USPTO) and the European Patent Office for the patent entitled "Biomarker identification" (U.S. Application No. 14/90012, EPO Application No. 14814334.0). These applications relate to SeptiCyte™ technology biomarkers used in differentiating infection-negative (SIRS) and infection-positive systemic inflammation (sepsis).
"These significant patent allowances cover the core biomarkers used to differentiate sepsis patients with SeptiCyte™ technology," commented Rolland D. Carlson, PhD, President and Chief Executive Officer of Immunexpress. "In combination with other granted Immunexpress patents, these patents reinforce the distinctiveness of the SeptiCyte™ technology for differentiating infection-negative and infection-positive systemic inflammation in patients suspected of sepsis. Gaining patent protection for specific biomarkers and biomarker combinations further distinguishes Immunexpress as the leader in host response analysis for sepsis diagnostics in both Europe and the U.S."
Annually, sepsis affects an estimated 20-30 million people worldwide1 and represents a major unmet medical need. According to the Agency for Healthcare Research and Quality, sepsis is the most expensive condition treated in U.S. hospitals2 with a mean cost per patient in 2014 of $US29,290. Similar mean hospital costs per stay for sepsis have been determined in Europe ($US37,424)3. In the U.S., between 2005 and 2014, the total annual cost of sepsis hospitalization increased from $22.2B to $38.1B4.
Immunexpress has been an early leading innovator in developing whole-blood, host gene expression biomarkers for differentiating systemic inflammatory conditions caused by infectious and non-infectious agents, resulting in the first FDA cleared product(SeptiCyte™ LAB) for differentiating sepsis from SIRS in early 2017.
These patent allowances protect a treatment method and a diagnostic method using specific biomarkers in whole blood samples from patients with systemic inflammation, adding to the current Immunexpress portfolio of 14 patent families. It significantly enhances Immunexpress' claims of the SeptiCyte™ technology, in particular, its application on the Biocartis Idylla™4 platform in the U.S. and Europe, which aims to rapidly provide clinicians with diagnostic information to aid in differentiating sepsis and non-infectious systemic inflammation (SIRS).
Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular markers from the patient's own immune system – the 'host response'. SeptiCyte™ LAB, recently cleared by the FDA, is the first of its kind in using the host immune system to differentiate systemic inflammatory response syndrome (SIRS) and sepsis. Detecting the host's response to infection has the potential to differentiate infection earlier, faster and more accurately than finding the invading pathogen because it is independent of whether or not the pathogen is present in the sample. Immunexpress' pipeline includes several sample-to-answer assays for near-patient testing.
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World Sepsis Day Factsheet 2018, available at https://www.world-sepsis-day.org/toolkits/.
Torio and Andrews, "National Inpatient Hospital Costs: The Most Expensive Conditions by Payer", 2011: Statistical Brief #160. In: "Healthcare Cost and Utilization Project (HCUP) Statistical Briefs, Rockville (MD)": Agency for Health Care Policy and Research (US) 2006-2013.
H. Arefian, et al., Hospital-related cost of sepsis: A systematic review, Journal of Infection, 1–11 (2016).
M. Rubens, et al., Increasing Sepsis Rates in the United States: Results From National Inpatient Sample, 2005 to 2014, J Intensive Care Med, 885066618794136 (2018).
Idylla™ is a registered trademark of the Biocartis Group.