Systagenix announces CE mark and first commercial shipment of WOUNDCHEK™ Protease Status, making it the world’s first poin

GATWICK, England--(BUSINESS WIRE)-- Wound care clinicians’ calls for better diagnostic tools to aid wound assessment have today been answered with the CE marking of WOUNDCHEK™ Protease Status, the world’s first rapid, point-of-care diagnostic test developed specifically for chronic wounds. WOUNDCHEK™ Protease Status has the potential to revolutionise wound care by enabling early, targeted intervention and cost-effective use of advanced therapies designed to modulate protease activity. Systagenix is initially introducing the test across Europe, South Africa and the Middle East and can confirm that commercial shipment of the first WOUNDCHEK™ Protease Status test kits has commenced.

WOUNDCHEK™ Protease Status, the world’s first rapid, point-of-care diagnostic test developed specifi ...

WOUNDCHEK™ Protease Status, the world’s first rapid, point-of-care diagnostic test developed specifically for chronic wounds from Systagenix (Photo: Business Wire)

Developed by Systagenix Wound Management in collaboration with Alere, and designed to form part of routine wound assessment, WOUNDCHEK™ Protease Status is easy-to-use and provides results in just 15 minutes at the point of care. This enables the test to immediately influence treatment decisions and help clinicians target advanced wound care therapies more effectively by identifying when elevated protease activity (EPA) exists in chronic wounds.

Although widely understood and recognized as a key marker in wound healing1, today EPA in chronic wounds goes undetected, as there are no visual cues for it2. A recently published study showed that chronic wounds with EPA have a 90% probability they will not heal without appropriate intervention3. The estimated 30 million chronic wounds treated each year account for approximately 3% of total health expenditure4. Until now, with almost 30% of non-healing wounds having EPA, the absence of a test could result in ineffective treatment choices, leading to significant cost to healthcare providers.

Professor Keith Harding, School of Medicine, Cardiff University, UK, and chair of the International consensus ‘The role of proteases in wound diagnostics’, commented: “Evaluation and assessment are the first steps every wound care clinician should take when presented with a chronic, hard-to-heal wound, but up until now we have not benefitted from innovation in this field. With the introduction of WOUNDCHEK™ Protease Status, Systagenix has been bold enough to invest in the field of diagnostics, and I applaud them for doing so. The effective use of a point-of-care test for protease activity has the potential to revolutionise wound care globally. This makes the WOUNDCHEK™ Protease Status test result invaluable information that clinicians will need to have on hand when evaluating and assessing chronic wounds.”

Louise Hambrook, Systagenix Global Category Director for Diagnostics added: “We’re delighted that leading clinicians are recognising the potential impact WOUNDCHEK™ Protease Status will have on the way wound care is provided. The damaging effect of EPA on wound healing has been widely documented over the years, but it is only now that we can appreciate and begin to identify its full impact. Clinicians can now detect its presence so that they can treat it accordingly. Knowing which wounds have EPA will allow clinicians to target their therapy choices, resulting in more cost-effective allocation of scarce resources, which in turn will benefit patients.”

As the implementation of point-of-care testing is new to many wound care clinicians, Systagenix is investing heavily in training prospective users and is pleased to introduce a new online training tool. Further details on WOUNDCHEK™ Protease Status, including the recent publications by Dr. Serena et al., Dr. Snyder et al., and Dr. Cullen et al. and information on how the test works, can be found on the Systagenix website:

Established in 2008, following the acquisition of Johnson & Johnson’s advanced wound care business, Systagenix supplies over 20 million advanced wound dressings per month into over 100 countries worldwide.

Disclaimer: WOUNDCHEK HAS NOT BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION FOR USE IN THE UNITED STATES. Statements concerning performance are limited to jurisdictions covered by the CE Mark.

Notes to Editors:

1. World Union of Wound Healing Societies. Principles of best practice: A consensus document: MEP Ltd. London, 2008.

2. Snyder, R. et al. A survey: the importance of proteases in wound healing and wound assessment. Poster, Wounds UK 2011.

3. Serena, T. et al. Protease activity levels associated with healing status of chronic wounds. Poster, Wounds UK 2011.

4. Posnett J, Franks PJ (2007) The cost of skin breakdown and ulceration in the UK. In: The Smith and Nephew Foundation (2007) Skin Breakdown – The Silent Epidemic. Smith and Nephew Foundation, Hull.

Further references:

  • Cullen, B. et al. Early Adoption of Collagen/ORC Therapies Improves Clinical Outcome. Poster, Wounds UK 2011.
  • International consensus. The role of proteases in wound diagnostics. An expert working group review. London: Wounds International, 2011.

Photos/Multimedia Gallery Available:


VSPR for Systagenix
Vicky Stoakes
+44 (0)7747 534 519
[email protected]

KEYWORDS:   United Kingdom  Europe

INDUSTRY KEYWORDS:   Health  Hospitals  Medical Devices  Pharmaceutical  Medical Supplies  Nursing


WOUNDCHEK™ Protease Status, the world’s first rapid, point-of-care diagnostic test developed specifically for chronic wounds from Systagenix (Photo: Business Wire)