CE Mark For WOUNDCHEK™Protease Status, First Point-of-care Diagnostic Test for Chronic Wounds

“Evaluation and assessment are the first steps every wound care clinician should take when presented with a chronic, hard-to-heal wound”


In a press release issued today Systagenix Wound Management has announced that it has gained CE mark status for its WOUNDCHEK™ Protease Status diagnostic tool to aid wound assessment.

The company claims this is the first rapid, point-of-care diagnostic test developed specifically for chronic wounds.


According to a company press release, Elevated Protease Activity (EPA) in chronic wounds leads to a 90% probability they will not heal without appropriate intervention. Despite being recognised as a key indicator of wound healing potential EPA is difficult to diagnose visually and frequently goes undetected. The company believes that with 30% of non healing wounds showing EPA there is a massive financial benefit to be had by improving diagnosis in order to then make effective treatment choices, not least the administration of advanced therapies designed to modulate protease activity.

Systagenix has collaborated with partner company Alere in the design of  the test, which 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 EPA exists in chronic wounds.

Clinician comments 

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.”

Company comments 

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.”


Now that it has CE mark approval, 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. 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 introducing a new online training tool.

Note: WOUNDCHEK has not been approved by FDA for use in USA. As such, statements concerning performance are limited to jurisdictions covered by the CE Mark.

We say

Another example of a new technology with the potential to help patients and save money. It’s going to need more clinical evidence than the small number of poster presentations appended on the press release, with extensive clinical trials no doubt in the pipeline before FDA approval and before it sees widespread clinical adoption.

Source: Systagenix