The National Institute for Health and Clinical Excellence (NICE) guidelines for early detection of ovarian cancer: the pivotal role of the clinical laboratory.

The National Institute for Health and Clinical Excellence (NICE) has recently reviewed optimal means of early recognition and initial management of ovarian cancer, the leading cause of gynaecological death in the UK. The NICE guidelines state that general practitioners should measure serum CA125 in women presenting with persistent and continuous symptoms suggestive of ovarian cancer (e.g. abdominal distension, early satiety and loss of appetite or pelvic pain). If CA125 is ≥35 kU/L, the general practitioner should arrange an ultrasound scan of the abdomen and pelvis to enable calculation of the risk of malignancy score (RMI). Women with an RMI score of ≥250 should then be referred to a specialist multidisciplinary team. Successful implementation of these guidelines requires close liaison between primary care and laboratory medicine to ensure that CA125 is requested as a diagnostic aid only for women meeting the criteria stated in the guidelines. Preanalytical criteria must also be met and it is essential that both requestors and patients be aware of other possible causes of increases in CA125, as well as the fact that it is not raised in all patients with ovarian cancer. Guidance is being prepared to enable appropriate interpretation and implementation of the NICE guidelines. Continuous audit of the outcomes will also be essential to determine the effectiveness of this approach to early detection of ovarian cancer.