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Ark Completes Development of oxLDL Diagnostic Kit

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Ark Therapeutics Group plc. has announced that it has completed the development and European CE marking of its oxidised low density lipoprotein antibody testing kit, oxLDL. 

The diagnostic kit will be used to predict whether an individual is at risk of having a heart attack.

Attempts to produce a reliable and easy to use test to measure oxLDL have not been successful to date, as the oxLDL molecule only exists for a very short time in the blood. 

However, as oxLDL is released into the blood, it rapidly produces an antibody response.  Ark’s test is a sensitive measure of the level of antibodies that are produced in response to oxLDL. 

The test also contains a control chemical to check whether a positive result is real or false. Clinical results to date using Ark’s test have shown that the test is applicable to approximately 75% of people and is highly predictive. 

In a study of patients with chest pain entering hospital for investigation, 81% of the patients who tested positive using Ark’s kit were subsequently confirmed as having a serious cardiovascular problem (heart attack or unstable angina).

C-reactive protein (CRP), one of the current ‘gold standards’ in predicting risk of cardiovascular problems, was predictive in only 29% of the cases in the same study. 

Professor John Martin, Chair of Cardiovascular Medicine at University College London and Chief Scientific Officer at Ark, commented, “This new diagnostic is highly predictive and has the potential to save many lives.” 

"It should prove a very useful addition to the overall cardiovascular risk testing approach."

Dr Nigel Parker, Chief Executive of Ark, added, "This is the second product that Ark has taken all the way through the development process to CE marking."

"We shall now be seeking specialist diagnostic partners to help us market the product and ensure that it realises its full commercial potential."