Next-generation sequencing panel for solid tumour cancers in children

Regulatory information

Laboratories running NGS panel tests must meet United Kingdom Accreditation Service (UKAS) Clinical Pathology Accreditation (CPA) or ISO15189:2012 (Medical laboratories – Requirements for quality and competence) standards.

The Royal Marsden NHS Foundation Trust that currently offers this test meets the standards (CPA number 2898), with ISO15189:2012 inspection due in December 2017.

All equipment, including the Illumina Miseq and Nextseq500 sequencers are kept in service contract and routine maintenance is logged as per ISO regulation. The Nextseq500 sequencer is CE marked to Electromagnetic Compatibility (EMC) Directive 2014/30/EU, Low Voltage Directive 2014/35/EU and Radio Equipment Directive (RED) 2014/53/EU.