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Towards new diagnostic standards - Development of a Protein Based Diagnostic Assay and of a Novel Anti-Abortion Drug Target (PIBF)

Final Report Summary - PIBF (Towards new diagnostic standards - Development of a Protein Based Diagnostic Assay and of a Novel Anti-Abortion Drug Target)

The objective of this cooperative research project was to develop a single, inexpensive in vitro immunodiagnostic assay kit for the measurement of the protein called Progestrone induced blocking factor (PIBF) in urine and blood samples that can be potentially used in the diagnostics of pathological pregnancy and cancer.

Earlier studies revealed that the concentration of PIBF in the urine and blood of healthy pregnant women increases during pregnancy and decreases rapidly during delivery. PIBF levels in biological fluids from women with pregnancy complications were significantly lower and PIBF concentrations were related topregnancy outcome. Concerning the role and impact of PIBF in the early gestational period on and In Vitro Fertilization no study has been performed. Since at present no marker is available to predict pregnancy outcome, one of our aims was to set up an ELISA test for measuring PIBF in urine and serum samples.

In this project, an inexpensive, simple, one-plate ELISA assay kit for the measurement of PIBF protein in serum and urine samples has been developed. This test has limited sensitivity and precision due to the biological diversity of the tested protein, but was proved to have very good inter-laboratory reproducibility. A very large batch of GMP grade reagents, including the same batch of polyclonal antibody has been produced for further manufacturing of the same kit sufficient for millions of clinical measurements. Studies on clinical samples have confirmed the potential role of PIBF in certain pathological pregnancies, and the expression of PIBF by cancer cells and elevated serum and urine levels of PIBF in certain cancer patients. The final clinical value of the PIBF ELISA test in the diagnostics of pathological pregnancy and cancer, and the determination of the size of the market for this kit requires further studies. Our results indicate that similarly to other clinical markers, including the other marketed tumour marker tests, PIBF test alone does not provide sufficient specificity and sensitivity to be used as a single screening diagnostic method. The developers of this kit, however, hope that in combination with other diagnostic tests, this assay will contribute to the higher diagnostic standards of pathological pregnancies and malignant tumours, and will provide diagnostic information for individualized, PIBF-based targeted therapies of both groups of patients.