NIBSC

Affiliate Organisation

The National Institute for Biological Standards and Control (NIBSC, UK)

NIBSC

The National Institute for Biological Standards and Control (NIBSC, UK) is a global leader in the characterisation, standardisation and control of biological medicines. NIBSC plays a major role in assuring the quality of biological medicines worldwide through the provision of biological reference materials, by testing products and carrying out research. Our expert scientists also provide advice on a routine basis and in response to emergencies.

NIBSC is the only producer of World Health Organization (WHO) international standards for genomic diagnostics, and is the only European producer of human genomic DNA reference materials for in vitro diagnostic use. WHO international standards are intended for use as primary reference materials in the calibration of secondary reference materials, kits, and assays; our CE-marked genomic reference materials are intended as ‘run-controls’ in diagnostic assays. The NIBSC programme was initiated with the development of genomic reference materials for qualitative genomic diagnostic assays, but in recognition of the increasing requirement for quantitative assays, particularly for cancer diagnostics where biomarker levels determine treatment and prognosis, the need for quantitative standards to both calibrate and determine assay sensitivity is critical, evidenced by the establishment of WHO international reference panels for BCR-ABL and JAK2 V617F.

NIBSC is keen to work with external parties to develop genomic reference materials where needed and unavailable.

For more information, please visit NIBSC genomic reference materials.