Companion Diagnostics: CDx - Improving therapy success

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Companion Diagnostics

The holy grail of medicine is the truly personalized treatment of every patients, providing the best possible therapy option. However, even if because of technical, ethical or financial reasons the realization is not to be expected soon, Companion Diagnostics or short CDx can be an important improvement in medicine already today.

Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution.  –  Albert Einstein

At PLS-Design, CDx is envisioned to be used for therapy stratification and monitoring of insect venom allery patients. Insect venom allergy is not as common as hay fever, but approximately every fourth person in Germany is sensitized against hymenoptera venom (honey bee and wasp). Most people will only experience mild symptoms, but the special reason to improve immunotherapy options is that up to 5% of the population will suffer serious anaphylactic shock reactions if stung by an insect. In certain patient groups the risk is even higer, e.g. mastocytosis patients. If not treated immediately, the vascular reactions can be fatal. It is not so much the actual incidence, but the fear of encountering insects, that is tremendously reducing the quality of life for many patients.

Today’s option of treatment is hyposensitization with natural venom extracts. Since it is a natural product not all allergens will be present in the same concentrations in all preparations. It could be shown that some allergens are underrepresented in some products. On the other hand, since it is an composition of several allergens the patient is also given antigens he/she is not allergic to. In the course of the therapy it can even happen that a de novo sensitization takes place. Instead of being healed from allergy the patient aquires a new allergy. In general the aim of any specific immunotherapy is to reduce the symptoms. In case of insect venom allergy patients, reducing the symptoms to harmless level would be an success. The logical first step is to identify the exact pattern of the allergic reaction against the numerous antigens in insect venom.

PLS-Design has cloned and expressed an array of recombinant insect venom allergens, for testing the reactivity pattern of patients (see also “Recombinant Allergens”). If a patient is monosensitized against one allergen, e.g. it must be verified that the therapy product is providing this allergen in sufficient amounts to induce the hyposensitization.

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