WOUNDCHEK™ Laboratories has received market clearance from
Health Canada for WOUNDCHEK™ Protease
Status, the world's
first and only point
of care test to
detect EPA in
chronic wounds.
WOUNDCHEK™ Protease Status receives market clearance in Australia
WOUNDCHEK™ Laboratories to exhibit at WUWHS, Florence, Italy, 25-29 September, 2016
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Previously the Diagnostic division of Systagenix, WOUNDCHEK™ Laboratories is focused on the development of novel wound diagnostics products to help improve therapeutic outcomes in wound care. Currently, the cost of ineffective treatment is estimated to be $20-25 billion¹Data based on savings calculated with the WOUNDCHEK economic model, UK version, with AQP VLU data inputs. – Nherera L. et al. Quantifying the economic value of diagnostics in wound care in the UK. Poster, EWMA 2013. annually. Clinical experts agree the use of point of care wound diagnostic devices could reduce the cost of ineffective treatment and delayed healing by being able to target the right therapy, on the right patient, at the right time, and for the right length of time²World Union of Wound Healing Societies (WUWHS). Principles of best practice: Diagnostics and wounds. A consensus document. London: MEP Ltd, 2008.. A resulting financial benefit to health care systems can be achieved through significant reduction of the expenses associated with poor targeting of treatment, delayed healing, and avoidable complications. WOUNDCHEK™ Laboratories launched the world’s first and only point of care test to detect EPA (elevated protease activity) in chronic wounds in 2012, and over the past several years has become a recognized leader in wound diagnostics.
The company’s vision is to provide clinicians with better, accurate, timely, actionable, and easy to access information, leading to improved therapeutic outcomes through point of care wound diagnostics. WOUNDCHEK™ Laboratories aims to be the leading and dominant enterprise in wound diagnostics by providing medical professionals with the diagnostic information to:
Identify wounds which are not healing
Intercept issues and early warnings that cause poor wound healing or initiate wounds
Aid in determination of best therapeutic routes
Monitor the effectiveness of a course of treatment
Based in the UK and the USA, WOUNDCHEK™ Laboratories' staff are focused on product development, clinical research, and working with its distribution partners to develop the emerging wound diagnostics markeg.
Our research is centred on two critical questions, identified by clinical experts as primary pieces of diagnostic information needed to direct treatment pathways in the majority of chronic wounds:
Does the wound have Elevated Protease Activity?
Is there an active infection?
WOUNDCHEK™ Protease Status, the world’s first and only point of care test to detect EPA (elevated protease activity), was launched in 2012 and cleared for sale in Europe, the Middle East, South Africa, and Canada.
ISO 9001:2008 and ISO 13485:2003 certified quality management system.
The strategy of WOUNDCHEK™ Laboratories is to be the leading and dominant enterprise in wound care diagnostics by providing medical professionals with the diagnostic information to:
Identify wounds which are not healing
Intercept issues and early warnings that cause poor wound healing or initiate wounds
Aid in determination of best therapeutic routes
Monitor the effectiveness of a course of treatment
Clinical experts identified numerous markers that could form the basis of new diagnostic tools for use in wound care1World Union of Wound Healing Societies (WUWHS). Principles of best practice: Diagnosis and wounds. A consensus document. London: MEP Ltd, 2008.(see slide above).
Developed to aid wound assessment and help clinicians target advanced wound care therapies more effectively, WOUNDCHEK™ Protease Status is able to detect EPA (elevated protease activity). As there are no visual cues for EPA, wounds with EPA have so far gone undetected1Snyder R. et al. A survey: The importance of proteases in wound healing and wound assessment. Poster, Wounds UK 2011..
WOUNDCHEK™ Protease Status will help clinicians establish within minutes which wounds may most benefit from a protease modulating therapy, ensuring appropriate and targeted use of these therapies.
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DESCRIPTION |
CONTAINS |
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WOUNDCHEK™ Protease Status |
12 tests (all material needed) |
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WOUNDCHEK™ Protease |
3 spare reagent bottles |
Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States
View Instructions For Use (pdf)
Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States
Frenthoff, E. et al. 2015. Testing and treating for elevated protease activity (EPA) in wound care clinics improves clinical outcome at no additional cost
Uccioli, L. et al. 2014. The presence of elevated protease activity (EPA) influences the integration of dermal grafts in diabetic foot ulcers
Gibson, M. et al. 2013. Testing chronic wounds for EPA. The benefits of testing all wounds, whether assessed as healing or non-healing
Ivory, 2013. The cost implications of implementing Woundchek Protease Status into clinical practice
Ivory, 2013. Assessing chronic non healing wounds for elevated protease activity
Anichini, R. et al. 2013. Detecting and treating Elevated Protease Activity (EPA) in chronic diabetic wounds
Dissemond, J. et al. 2013. EPA made easy
Duteille, F. 2013. Evaluation of the use of point-of-care test for proteases to identify patients with increased risk of skin graft failure
Nherera, L. et al. 2013. Quantifying the economic value of diagnostics in wound care in the UK
International case series: Using Promogran/Promogran Prisma on wounds with elevated protease activity: case studies. London: Wounds International, 2013.
Young, T. 2012. Using a protease test to inform wound care treatment decisions
Haycocks, 2012. Assessing chronic diabetic foot wounds for elevated protease levels
Hodgson, 2012. Clinical skills of tissue viability nurse versus Woundchek to detect elevated protease activity (EPA)
Serena, T. et al. 2012 Preliminary results: Testing for elevated protease activity in clinical practice
Johnstone, 2012. Case Studies: Testing for and treating EPA
Cullen, B. et al 2012. Targeted use of Collagen/ORC improves clinical outcome
Serena, T. et al. 2011. Protease activity levels associated with healing status of chronic wounds
Snyder, R. et al. 2011.The importance of proteases in wound healing and wound assessment
Diabetic Foot Ulcers: Prevention, Care and Treatment Spanish Diabetes Foundation, 2014
Die tolle eines proteasen schnelltests in der wunddiagnostik DACH, 2013
Using a diagnostic tool to identify elevated protease activity levels in chronic and stalled wounds USA, 2013
Protease diagnostic in wound care UK, 2012
Role of proteases in wound diagnostics International, 2012
Significato e valutazione delle proeasi nel processo di riparazione tessutale Italy, 2012
The role of a point-of-care protease activity diagnostic test in Canadian clinical practice Canada, 2012
World Union of wound healing societies consensus document International 2012
Dr. Läuchli, Dr. Anichini, Dr. Dowsett, and Prof. Duteille, EWMA 2013 EPA, guiding treatment decisions for improved clinical results and cost effective care
Dr. Serena, Dr. Fletcher, and Dr. Läuchli, EWMA 2012 Testing for EPA, the arrival of wound diagnostics
Dr. Thoms, Training Event 2012 Proteases: Background, Assessment, and Treatment of EPA in chronic wounds (in German)
Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States
Bacteria are in a pathogenic state when they are either in the process of, or they are capable of, causing disease, i.e. infection. One measure of pathogenicity is the production of enzymatic virulence factors called bacterial proteases1Lebrun I, Marques-Porto R, Pereira AS, Pereira A, Perpetuo EA. Bacterial toxins: an overview on bacterial proteases and their action as virulence factors. Mini-reviews in medicinal chemistry 2009; 9 (7): 820-8.. A number of known proteases have been characterised from some of the frequently reported bacteria in chronic wounds2Koziel J, Potempa J. Protease-armed bacteria in the skin. Cell Tissue Res. 2012; 351(2): 325-37.,3Potempa J, Pike RN. Corruption of innate immunity by bacterial proteases. J. Innate Immun. 2009; 1: 70-87.. The impact of bacterial proteases has been documented in a range of acute and chronic medical conditions, including cystic fibrosis, eye infections and wound infections3Potempa J, Pike RN. Corruption of innate immunity by bacterial proteases. J. Innate Immun. 2009; 1: 70-87.,4Twining SS, Kirschner SE, Mahnke LA, Frank DW. Effect of P aeruginosa elastase, alkaline protease, & exotoxin A on corneal proteinases and proteins. Invest. Ophthalmol. Vis. Sci. 1993; 34(9): 2699-712..
The detection of bacterial protease activity in a chronic wound would be indicative of the presence of bacterial pathogenesis which is a precursor to clinical signs and symptoms of infection5Thomson PD, Smith DJ. What is infection? Am. J. Surg. 1994; 167(No. 1A): 7S-10S.,6Dow G, Browne A, Sibbald RG. Infection in chronic wounds: Controversies in diagnosis and treatment. Ostomy Wound Management 1999; 45 (8): 23-40..
Bacterial pathogenesis is undesirable since, at this stage, the wound is in a part of the wound infection continuum that typically requires intervention.
WOUNDCHEK™ Bacterial Status - Coming Soon!
Serena, T. et al. 2015. Bacterial proteases: A marker for a 'state of pathogenesis' in chronic wounds
Serena, T. et al. 2015. Bacterial protease activity in chronic wound fluid, a potential indicator of pathogenicity even in the absence of overt signs of infection.
Benson, R. et al. 2013. Bacterial protease activity, an indicator of bacterial pathogenicity in chronic wounds even in the absence of overt clinical signs.
The Use of a point-of-care test for bacterial protease activity in chronic wounds Wounds International 2015, Vol 6 Issue 4
Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States
Jack Wilkens
Chief Executive Officer
Simon Bayliff
Vice President, R&D
Malcolm Williams
Chief Financial Officer
Patrick Brosnan
Scientist
Gill Witherington
Administrator
Bob Dicheck
Regulatory
Richard Collette
Commercial
Jack Wilkens
Chief Executive Officer
Leon Okurowski
Bill Umphrey
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Jack Wilkens Former Systagenix Vice President of Diagnostics Development, CEO of RevDia, which specializes in infectious disease point of care diagnostic testing. Prior to RevDia, he was Chief Operating Officer for Inverness Medical Innovations (now Alere - ALR-NYSE), a world leader in point of care rapid diagnostics. He has also held senior management positions with Unipath, IMI, Sterling Diagnostics / AGFA and Polaroid Corporation. Mr. Wilkens has a BS in Chemical Engineering and an MBA. |
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Simon Bayliff Simon is a Biochemistry & Physiology graduate with nearly 30 years' experience developing products in the Medical Device and In-Vitro Diagnostic fields. He has worked in 'start-up' environments and for companies including Abbott Laboratories and Johnson & Johnson. |
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Patrick Brosnan, BSc Patrick has worked in wound care for the past five years, with Systagenix. He worked for four years as an R&D scientist and more recently has moved into the clinical side of the company, helping run, monitor and analyse trials in USA. Patrick graduated from The University of Manchester in 2008 with a BSc (hons) in Biology. |
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Gill Witherington Gill has worked in admin for 13 years in Gargrave, firstly for Johnson & Johnson, which then became Systagenix Wound Management for the Research & Development Department and has to be able to deal with a vast range of tasks. |
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Malcolm Williams Malcolm is a fellow of the chartered institute of management accountants (UK) as well as having an honours degree in accountancy and finance. He spent 22 years with Johnson and Johnson working mainly in medical devices and diagnostics. Latterly he was the international finance director for Ortho Clinical Diagnostics covering Europe, Africa and Asia. He now works for several start up businesses. |
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Bob Dicheck Bob Dicheck is an experienced regulatory and quality management professional, who has been involved in U.S. and international regulated industries for more than 30 years. Previously he was Vice President of Quality & Regulatory Affairs for Osmetech Molecular Diagnostics and Vice President Worldwide QA/RA at Unipath, Inverness Medical Innovations. Prior to that Bob held a variety of corporate and global franchise executive level QA/RA positions over 14 years within the Johnson & Johnson family of companies. |
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Richard Collette Richard Collette is an experienced Commercial Business Leader in international business development for medical products such as diagnostic imaging equipment, tele-care for chronic wound management, IVDs, and implantable devices covering the past 20 years. Most recently, he was President of the USA and Canada marketing, sales, distribution, and service operation for one of the leading suppliers of implants that restore hearing to those challenged with profound hearing loss. |
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Jack Wilkens Former Systagenix Vice President of Diagnostics Development, CEO of RevDia, which specializes in infectious disease point of care diagnostic testing. Prior to RevDia, he was Chief Operating Officer for Inverness Medical Innovations (now Alere - ALR-NYSE), a world leader in point of care rapid diagnostics. He has also held senior management positions with Unipath, IMI, Sterling Diagnostics / AGFA and Polaroid Corporation. Mr. Wilkens has a BS in Chemical Engineering and an MBA. |
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Leon Okurowski Mr. Okurowski is the Vice President of Pear Tree Advisors and the co-founder and Vice-President of the Pear Tree Funds. He is also Vice President and Treasurer for various U.S. Boston entities. Mr. Okurowski has over forty years experience in the finance and investment management business. Mr. Okurowski obtained his MBA from the Whittemore School of Business at the Univerity of New Hampshire, his MS in taxation from Bentley College, and a BS from the United States Naval Academy. He has served on the boards of several high-tech companies. He was a co-founder and served on theboard of Atlantic Bank and Trust Prior to joining U.S. Boston, |
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Bill Umphrey Mr. Umphrey is the Chairman and co-founder of the Pear Tree Funds, the President of Pear Tree Advisors, Inc., and the Chairman of U.S. Boston Capital Corporation. Mr. Umphrey founded the U.S. Boston's predecessor in 1969 and has over forty years of experience in the finance and investment management business. Mr. Umphrey obtained his JD from Harvard Law School, an LLM in taxation from Boston University of Law, a Masters in Personnel Administration fron George Washington Univeristy, and a BS with distiction from the United States Naval Academy in Annapolis, Maryland. Prior to founding U.S. Boston, |
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News
Date: Sep 8, 2016
Date: Dec 7, 2015
Date: May 14, 2015
Date: Apr 16, 2015
Date: Sep 8, 2016
WOUNDCHEK™ Laboratories announced today that WOUNDCHEK™ Protease Status, the world's first point of care wound diagnostic for chronic wounds, has received market clearance from the Australian Therapeutic Goods Administration.
WOUNDCHEK™ Protease Status receives market clearance in Australia
Fall River, MA, USA – September 5, 2016 – WOUNDCHEK™ Laboratories announced today that WOUNDCHEK™ Protease Status, the world’s first point of care wound diagnostic for chronic wounds, has received market clearance from the Australian Therapeutic Goods Administration. Intermed Medical Pty Ltd has been appointed as distributor for the product in Australia and New Zealand.
WOUNDCHEK™ Protease Status, already available in Europe, Canada & South Africa, detects a chronic inflammatory response in the wound, as indicated by elevated human protease activity (EPA) and was developed to help guide treatment decisions to enable improved outcomes and more cost effective care. “Protease activity is an essential part of wound healing. However, once out of control, and if left unchecked, proteases in wounds may cause sufficient damage.… to impair healing and destroy normal tissue.” (Wounds International Consensus “The role of proteases in wound healing”, 2011, pp1).
Also currently in clinical trial is a new point of care test to detect when bacteria in the wound have become pathogenic, as indicated by bacterial protease activity (BPA). This test will help identify wounds in which bacteria may be delaying healing, which could assist clinicians in determining when interventions to reduce bacterial burden are indicated, particularly in chronic wounds with no obvious signs of infection.
Jack Wilkens, CEO of WOUNDCHEK™ Laboratories, commented: “We are delighted with the news that our first product has been cleared for sale in Australia and will be distributed by Intermed Medical Pty Ltd, a company with a strong track record in marketing innovative wound care products. Currently, the global cost of ineffective treatment is estimated to be $20-25 billion annually. Our vision is to provide clinicians with accurate, timely, actionable, and easy to access information, leading to improved therapeutic outcomes and more cost effective care through point of care wound diagnostics.”
For more information, contact:
Richard Collette at WOUNDCHEK™ Laboratories on richard.collette@woundchek.com
Or
Australia: Ben Darling at Intermed Medical on ben.darling@intermedmedical.com.au
New Zealand: Ashley Witheford at Intermed Medical on ashley.witheford@intermed.co.nz
Contact UsWOUNDCHEK™ Laboratories
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