Development of easy-to-use and reliable test to identify pregnant women at risk of causing FNAIT.

This project aims to develop the first easy-to-use and reliable test to identify pregnant, HPA-1a negative women at risk of causing FNAIT. General HPA-1 phenotyping will immediately enable obstetricians to improve FNAIT prevention and management strategies and the prophylactic treatment NAITgam may soon be available and eliminate the risk of FNAIT. These pro-active measures are, however, critically dependent on the availability of a reliable test for HPA-1 typing and early detection of HPA-1a antigen incompatibilities. Proof of Concept for HPA-1a typing has been obtained in the two dominating test formats for RhD typing of pregnant women, solid phase and gel card, which enables seamless integration of mandatory HPA-1a typing vis-a-vis RhD typing. The US-based world-leader in blood group typing, Immucor, which uses the solid phase platform, has now sublicensed the technology and will by 2017 commercialize the world's first test for high-throughput and cost-effective HPA-1a phenotyping. Additionally, Immucor has an obligation to globally supply the sublicensed monoclonal T1 HPA-1a antibody (GMP-grade), which also enables HPA-1a typing on the competing gel card platform.

Foetal/Neonatal Alloimmune Thrombocytopenia (FNAIT) is a serious bleeding disorder that most often is caused by the destruction of blood platelets in a foetus or newborn by maternal antibodies towards HPA-1a. Upon exposure to these antibodies, the foetus or newborn may become thrombocytopenic and suffer from excessive bleeding, e.g. intracranial haemorrhage which can result in lifelong disability or death. 2% of all mothers lack the HPA-1a allotype epitope and are at risk of developing a damaging immune r esponse against the platelets of their HPA-1a positive foetus. This project aims to develop the first easy-to-use and reliable test to identify pregnant, HPA-1a negative women at risk of causing FNAIT. General HPA-1 phenotyping will immediately enable ob stetricians to improve FNAIT prevention and management strategies and the prophylactic treatment Tromplate may soon be available and eliminate the risk of FNAIT. These pro-active measures are, however, critically dependent on the availability of a reliabl e test for HPA-1 typing and early detection of HPA-1a antigen incompatibilities.