About The ROCA Test

involving over 4,300 women at an estimated >10% lifetime risk of developing ovarian cancer. All women participating in this study received ROCA every 4 months, and a transvaginal ultrasound if ROCA was abnormal. At the time of recruitment, women were asymptomatic women between 35 and 85 years old.¹

These results, published in the Journal of Clinical Oncology, showed:

• A highly significant reduction in the proportion of women being diagnosed with macroscopic metastatic disease outside the pelvis (from 95% to 37%).
• A significantly lower proportion of women requiring neoadjuvant chemotherapy (5% vs. 44%).
• A very high proportion (95%) with zero residual disease post-surgery, despite the lower use of neo-adjuvant chemotherapy. Zero residual disease status is one of the strongest predictors of prognosis in ovarian cancer.
• Only 21% of women undergoing surgery required anything more than a simple hysterectomy and omentectomy, compared with clinically presenting cases, where surgery is usually more complex and frequently involves other procedures such as bowel resection.

Qualitative data from the UK cohort suggests that surveillance itself may prompt women to focus on their risk of cancer and push them towards the risk-reducing surgery which they need.² Therefore, another important secondary benefit of surveillance may be that it encourages uptake of a proven cancer prevention strategy.

A parallel US publication demonstrated similarly encouraging earlier stage diagnosis, despite the small number of incident cancers.³

The results reported in UKFOCSS have been replicated in a NHS implementation study for women at high risk of ovarian cancer, and specifically those who carry a genetic mutation in one of the two BRCA genes. This study is called ALDO (Avoiding later Diagnosis of Ovarian cancer) the results from which are published in the Journal of Medical Genetics⁴.

The study recruited 875 female BRCA1/2-heterozygotes at 13 UK centres and via an online media campaign, with 767 undergoing at least one 4-monthly surveillance test with the ROCA Test. Surveillance performance was calculated with modelling of occult cancers detected at the time of risk reducing salpingo-oophorectomy (RRSO). The incremental cost-effectiveness ratio (ICER) was calculated using Markov population cohort simulation.

The study identified 8 women with ovarian cancer (OC) during 1277 women screen years: 2 occult OCs at RRSO (both stage 1a), and 6 surveillance-detected; 3 of 6 (50%) were ≤stage 3a, and 5 of 6 (83%) were completely surgically cytoreduced.

Modelled sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for OC were 87.5% (95% CI, 47.3 to 99.7), 99.9% (99.9–100), 75% (34.9–96.8) and 99.9% (99.9–100), respectively.

The predicted number of quality-adjusted life years (QALY) gained by surveillance was 0.179 with an ICER cost-saving of -£102,496/QALY here

The conclusion was OC surveillance for women deferring RRSO in a ’real-world’ setting is feasible and demonstrates similar performance to research trials; it down-stages OC, leading to a high complete cytoreduction rate and is cost-saving in the UK National Health Service (NHS) setting. While RRSO remains recommended management, ROCA-based surveillance may be considered for female BRCA-heterozygotes who are deferring such surgery.