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Name

Prediction and therapy control of large vessel vasculitis

Organization name

ascenion GmbH

Profile

Challenge

Vasculitis represents a heterogeneous group of disorders leading to inflammatory destruction of blood vessels. Initial classification of vasculitis types may be achieved by the location, or the type or size of the blood vessels predominantly affected. However, the provision of diagnostic markers, particularly for early diagnosis, as well as for the identification of the status of disease and for the stratification of therapy regimen remains a challenge.

In the recent past, autoantibodies have been proven useful for classification of small vessel vasculitis. ANCAs (anti neutrophil cytoplasmic antibody) are found in patients with Wegener’s granulomatosis (WG), Microscopic polyangitis (MPA) and Churg Strauss syndrome (CSS). However, no autoantibodies specific for large vessel vasculitis types have been revealed yet.

Giant-cell arteritis (GCA) (also known as Morbus Horton or Arteriitiscranialis) is the main primary systemic vasculitis with a prevalence of 1:500 to 1:1000 in people older than 50 years in Germany. Thirty to sixty percent of patients with GCA are concomitantly affected with polymyalgia rheumatica (PMR). Until now, biopsy analysis of the temporal arteries remains the gold standard in diagnosing GCA. Since complete remission is achievable in case of early diagnosis, there is a continuing need for new and more specific molecular markers, in particular for large vessel vasculitis.

Technology

A newly developed test system identifying the presence of antibodies against ferritin or immunoreactive peptides thereof is indicative for the presence or the risk of development of large vessel vasculitis types like giant-cell arteritis (GCA), polymyalgia rheumatica (PMR) and GCA-related Takayasu’s arteritis. In addition, the system may be used for therapy regimen definition and monitoring. The marker has a diagnostic sensitivity of up to 93 %.

Commercial Opportunity

In-licensing opportunity for a diagnostic test based on patient blood samples.

Developmental Status

ELISA prototypes are available and have been conducted in patient population.

Patent Situation

A European patent application has been filed January 2011, followed by a PCT application in 2012.

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