General Overview

WOUNDCHEK™ Laboratories is focused on the development of novel wound diagnostic products to help improve outcomes in wound care. Currently, the cost of ineffective treatment is estimated to be more than $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. 

Mission

The company’s vision is to provide clinicians with better, accurate, timely, actionable, and easy to access information, leading to improved 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

Activities

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 market.

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 chronic inflammation?

  • Is there an active bacterial pathogenesis?

 

ISO 13485:2016 certified quality management system.

Bacterial Virulence

Bacterial proteases have been described as the most important class of virulence factors and play a key role in the establishment of wound infections, ultimately impeding the healing response and keeping the wound in a chronic state1Koziel J, Potempa J. Protease-armed bacteria in the skin. Cell Tissue Res. 2013; 351(2): 325-37.. They are produced by both Gram-negative and Gram-positive bacteria associated with chronic wound colonization2Wysocki AB, Bhalla-Regev SK, Tierno PM, Steven-Riley M, Wiygul R. Proteolytic Activity by Multiple Bacterial Species Isolated from Chronic Venous Leg Ulcers Degrades Matrix Substrates. Biol Res Nurs. 2012; 15(4): 407-415..

The detection of bacterial protease activity in a chronic wound would be indicative of the presence of bacterial virulence which is a precursor to clinical signs and symptoms of infection3Thomson PD, Smith DJ. What is infection? Am. J. Surg. 1994; 167(No. 1A): 7S-10S.,4Dow G, Browne A, Sibbald RG. Infection in chronic wounds: Controversies in diagnosis and treatment. Ostomy Wound Management 1999; 45 (8): 23-40. .

Bacterial virulence is undesirable since, at this stage, the wound is in a part of the wound infection continuum that typically requires intervention.

WOUNDCHEK™ Bacterial Status — Now available in countries accepting CE mark or FDA clearance!

PRODUCT CODE

DESCRIPTION

CONTAINS

360006

WOUNDCHEK™ Bacterial Status
Test Kit

6 tests (all material needed)

360010

WOUNDCHEK™ Bacterial Status
Control Kit

3 positive & 3
negative control swabs

The Only Test to Detect EPA

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.

WOUNDCHEK™ Protease Status product sizes — Now available in countries accepting CE mark!

PRODUCT CODE

DESCRIPTION

CONTAINS

350006

WOUNDCHEK™ Protease Status
6 Test Kit

6 tests (all material needed)

350010

WOUNDCHEK™ Protease
Status Control Kit

3 elevated result and
3 low result control swabs

Videos

Woundchek Protease Status Specimen Collection Video (the Serena Method)

Woundchek Protease Status Test Procedure Video

 

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

Evidence

  • Posters/Articles icon
  • Consensus Documents
  • Symposiums

Posters & Articles

Serena TE, et al, 2016. Defining a new diagnostic assessment parameter for wound care: Elevated protease activity, an indicator of nonhealing, for targeted protease-modulating treatment

Lazaro J., et al, 2016. Elevated levels of matrix metalloproteinases and chronic wound healing: an updated review of clinical evidence

Izzo I., et al, 2014. High matrix metalloproteinase levels are associated with dermal graph failure in diabetic foot ulcers

 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

pdf icon Anichini, R. et al. 2013. Detecting and treating Elevated Protease Activity (EPA) in chronic diabetic wounds

pdf icon Duteille, F. 2013. Evaluation of the use of point-of-care test for proteases to identify patients with increased risk of skin graft failure

pdf icon Nherera, L. et al. 2013. Quantifying the economic value of diagnostics in wound care in the UK

pdf icon International case series: Using Promogran/Promogran Prisma on wounds with elevated protease activity: case studies. London: Wounds International, 2013.

pdf icon 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

pdf icon Serena, T. et al. 2011. Protease activity levels associated with healing status of chronic wounds

pdf icon Snyder, R. et al. 2011.The importance of proteases in wound healing and wound assessment

Symposia

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

Evidence

  • Posters/Articles icon
  • Consensus Documents
  • Symposiums

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

Videos

Woundchek Specimen Collection Video (the Serena Method)

Woundchek Bacterial Status Test Procedure Video

Areas of Interest

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).

  • Jack Wilkens

    Jack Wilkens

    Chief Executive Officer

  • Simon Bayliff

    Simon Bayliff

    Vice President, R&D

  • Malcolm Williams

    Malcolm Williams

    Chief Financial Officer

  • Patrick Brosnan

    Patrick Brosnan

    Scientist

  • Gill Witherington

    Gill Witherington

    Administrator

  • Richard Collette

    Richard Collette

    Commercial

  • Jack Wilkens

    Jack Wilkens

    Chief Executive Officer

  • Leon Okurowski

    Leon Okurowski

     

  • Bill Umphrey

    Bill Umphrey

     

Jack Wilkens
Chief Executive Officer

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.

Simon Bayliff
Vice President, Research & Development

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.

Patrick Brosnan, BSc
Scientist

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. 

Gill Witherington
Administrator

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.

Malcolm Williams
Chief Financial Officer

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.

Bob Dicheck
Regulatory

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.

Richard Collette
Commercial

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.

Jack Wilkens
Chief Executive Officer

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.

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
Company, a public company.

Prior to joining U.S. Boston,
Mr. Okurowski served in the
United States Navy as a
submarine officer.

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,
Mr. Umphrey served in the
United States Navy as a
submarine officer.

Events icon Events

Date: Dec 2, 2019

FDA clears WOUNDCHEK™ Bacterial Status for use by wound care professionals


Woundchek Laboratories are excited to announce that the FDA has cleared Bacterial Status for use in the USA by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds.  Bacterial Status results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the assessment of risk for non-healing chronic wounds such as wound age, wound size, and vascular status.

Read More

Bacterial Status is intended for use in adult patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where patients are asymptomatic for clinical signs of infection.  The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are > 6 months of age that are < 1cm2 in size.

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Icon Address Contact Us

WOUNDCHEK™ Laboratories

CIE Bld.,
151 Martine St., Fall River,
Massachusetts, 02723,
United States of America
T: 888 685 0060

Airebank Mill
Gargrave; BD23 3RX
North Yorkshire
United Kingdom
T: +44 (0) 1756 639111

Icon EmailE: info@woundchek.com

Technical Helpline:
Americas: 888 685 0060
ROW: +800 1558 8551

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