Health Canada Approval and CE Mark - Procalcitonin Test Response Biomedical Corp (RBM:TSX) - News Alert
Response Biomedical Receives Health Canada Approval and CE Mark for the RAMP® Procalcitonin Test for Sepsis
Response Biomedical Corp. ("Response" or "the Company") (TSX:RBM)(OTCQB:RPBIF), has received Health Canada approval and CE Mark for a new RAMP(r) diagnostic test that measures the levels of Procalcitonin ("PCT"). PCT is a biomarker elevated in the blood of patients suffering from sepsis, also known as blood poisoning. Physicians today use PCT to distinguish bacterial sepsis from other causes of similar symptoms(1,2). The RAMP(r) Procalcitonin test is a rapid diagnostic assay that provides quantitative results in 15 minutes directly from a small blood sample.
Sepsis is a global problem, afflicting nearly 30 million people annually(3). The incidence of sepsis continues to increase by 2% - 9% per year(4,5). Despite advances in critical care medicine, sepsis is the leading cause of death in intensive care units in the US and is listed as one of the most expensive conditions treated in US hospitals, with costs exceeding $20 billion annually(6,7). Early detection and treatment of sepsis has been proven to improve patient outcomes and reduce healthcare costs(8,9). The traditional methods of sepsis diagnosis can take 24 hours or more, lack sensitivity and specificity and frequently do not correlate to the level of severity of the illness(10 ).
"The addition of the PCT test to the RAMP(r) platform supports our focus to provide high quality acute care tests to help improve patient outcomes," said Dr. Barbara Kinnaird, Chief Executive Officer of Response. "This new test demonstrates Response's ability to leverage its platform technology and to provide new revenue opportunities on the installed base of RAMP(r) readers. The achievement of our Health Canada approval and CE Mark for the RAMP(r) Procalcitonin test allows us to begin registrations and sales in select countries," noted Dr. Kinnaird.
About Response Biomedical Corp.
Response develops, manufactures and markets rapid on-site diagnostic tests for use with its RAMP(r) platform for clinical, biodefense and environmental applications. RAMP(r) represents a unique paradigm in diagnostics that provides reliable, quality results in minutes. The RAMP(r) platform consists of a reader and single-use disposable test cartridges and has the potential to be adapted to any medical and non-medical immunoassay based test currently performed in laboratories. Response clinical tests are commercially available for the aid in early detection of heart attack, congestive heart failure, bacterial sepsis, thromboembolism, influenza A and B and RSV. In the non-clinical market, RAMP(r) tests are currently available for the environmental detection of West Nile Virus and Dengue Fever antigen and for Biodefense applications including the rapid on-site detection of anthrax, smallpox, ricin and botulinum toxin. Response is a publicly traded company listed on the TSX under the trading symbol "RBM" and quoted on the OTCQB under the symbol "RPBIF". For further information, please visit the Company's website at
www.responsebio.com.
Forward-Looking Statements
This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about Response Biomedical Corp. Examples of forward-looking statements in this press release include statements regarding our belief that the incidence of sepsis continues to increase by 2% - 9% per year, that the addition of the PCT test to the RAMP(r) platform supports our focus in providing high quality acute care tests to help improve patient outcomes, that this new test is a demonstration of our ability to leverage our platform technology and to provide new revenue opportunities on the installed base of RAMP(r) readers, and that having both Health Canada approval and CE Mark allows us to begin registrations and sales into select countries. These statements are only predictions based on our current expectations and projections about future events. Although we believe the expectations reflected in such forward-looking statements, and the assumptions upon which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct and if such expectations are not met, our business may suffer.
Readers should not place undue reliance on these statements. Actual events or results may differ materially. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many factors may cause the Company's actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our annual report on Form 10-K, our quarterly reports on Form 10-Q, our Current Reports on Form 8-K, our Annual Information Form and other filings with the Securities and Exchange Commission and Canadian securities regulatory authorities.
The forward-looking statements contained in this news release are current as of the date hereof and are qualified in their entirety by this cautionary statement. Except as expressly required by applicable securities laws, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Uzzan et al. Procalcitonin as a diagnostic test for sepsis in critically
ill adults and after surgery or trauma: a systematic review and meta-
analysis. Crit Care Med 2006. 34:1996-2003
2 Schuetz et al. Procalcitonin for diagnosis of infection and guide to
antibiotic decisions: past, present and future. BMC Medicine 2011. 9:107-
15
3 Fleischmann et al. Global burden of sepsis: a systematic review. Critical
Care 2015, 19(Suppl 1): P21.
4 Angus et al. Epidemiology of severe sepsis in the United States: Analysis
of incidence, outcome, and associated costs of care. Crit Care Med 2001.
29(7): 1303-1310.
5 Martin G. Sepsis, severe sepsis and septic shock: changes in incidence,
pathogens and outcome. Expert Rev Anti Infect Ther 2012. 10(6):701-706.
6 Muller et al. Calcitonin precursors are reliable markers of sepsis in a
medical intensive care unit. Crit Care Med 2000. 28(4): 977-983.
7 Torio et al. National Inpatient Hospital Costs: The Most Expensive
Conditions by Payer, 2011. HCUP Statistical Brief #160. August 2013.
Agency for Healthcare Research and Quality, Rockville, MD.
8 Kumar et al. Duration of hypotension before initiation of effective
antimicrobial therapy is the critical determinant of survival in human
septic shock. Crit Care Med 2006. 34:1589-1596.
9 Shorr et al. Economic implications of an evidence-based sepsis protocol:
can we improve outcomes and lower costs? Crit Care Med 2007. 35(5):1257-
1262.
10 McGee et al. Procalcitonin: clinical utility in diagnosing sepsis. Clin
Lab News 2009. 35(7).
FOR FURTHER INFORMATION PLEASE CONTACT: Response Biomedical Corp. W.J. (Bill) Adams Chief Financial Officer 604-456-6010
ir@responsebio.com www.responsebio.com SOURCE: Response Biomedical Corp.
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