Abcodia Licenses the ‘Risk of Ovarian Cancer Algorithm’
Abcodia Licenses the ‘Risk of Ovarian Cancer Algorithm’ (Roca) Developed at Massachusetts General Hospital and Queen Mary, University of London
• Abcodia granted a world-wide exclusive license to ROCA®; potential for a major advance in screening for ovarian cancer.
• ROCA® is a diagnostic test that compares a woman’s individual longitudinal pattern of the CA-125 blood test over time, with the known profiles of thousands of women prior to diagnosis of ovarian cancer and women without ovarian cancer, to provide an accurate risk of having the disease.
• ROCA® has been developed and tested in studies involving over 200,000 women in the UK. Results of a recent study at the MD Anderson Cancer Center in the USA provide further evidence of high performance.
Abcodia, the biomarker validation company with a focus on screening for cancer, today announced that it has entered into an agreement for an exclusive world-wide commercial license to the Risk of Ovarian Cancer Algorithm (ROCA) developed at Massachusetts General Hospital (MGH) and Queen Mary, University of London.
ROCA has the potential to be a major breakthrough for the early diagnosis of ovarian cancer. The diagnosis of ovarian cancer is usually made when the disease has spread outside the ovaries and as a result the outcome is poor. In the 80% of cases of ovarian cancer in which diagnosis occurs in the later stages, the 5-year survival rate is less than 20%. If diagnosed early, 5-year survival exceeds 85%. Hence the need for early diagnosis, in the hope that current treatments will be more effective. Around the world, an estimated 200,000 new cases of ovarian cancer are diagnosed in women each year and there are over 125,000 deaths.
ROCA is a test being validated for the screening of ovarian cancer. It was invented by Professor Ian Jacobs, Dean & Head School of Medicine, Faculty of Medical & Human Sciences, University of Manchester, and formerly of Queen Mary, University of London, and Dr Steven Skates of the Biostatistics Center, MGH, who together studied longitudinal patterns of CA125 in multiple cohorts of post-menopausal women to develop a statistical algorithm efficiently combining information in age and serial CA125 levels. ROCA has since shown excellent specificity, Positive Predictive Value (PPV) and sensitivity in large studies including UKCTOCS (UK Collaborative Trial of Ovarian Cancer Screening) and UKFOCSS (UK Familial Ovarian Cancer Screening Study).
A recent study1 by the MD Anderson Cancer Center in normal risk postmenopausal women reported a specificity of 99.9% and a PPV of 40% for ROCA when ultrasound was used as a secondary test. This confirms, in a USA population, results previously reported by the larger UKCTOCS trial involving 202,000 normal risk postmenopausal women. The published results from UKCTOCS2 indicate that, as well as achieving high specificity and PPV, ROCA can achieve a sensitivity of 89% for screen detection of ovarian cancer. UKCTOCS is a randomised trial comparing screening with standard care, and in 2015 will provide results on the impact of screening with ROCA on mortality and survival from ovarian cancer. The final data from UKCTOCS will be of great importance in guiding future clinical use of the ROCA in clinical practice.
Commenting on the recent MD Anderson publication, Professor Ian Jacobs, also Director of the UKCTOCS trial, said: “I am delighted to see the outcome of the MD Anderson 11 year study. The results reassuringly confirm in a USA setting those reported from the UKCTOCS prevalence study published in 2009. We now await further data from UKCTOCS in 2015 to establish whether the encouraging specificity and sensitivity data translate into improvements in survival and mortality which through early detection can help women affected by ovarian cancer.”
Dr Julie Barnes, Abcodia’s CEO, said: “The licensing of ROCA is a significant opportunity for Abcodia and we now intend to work with the co-founders to actively plan a commercialisation path that will in due course enable ROCA to be made available to women in Europe, US and around the world. We are currently in active discussions with partners in different territories to support our mission. Based on the reports to date, and in particular the sensitivity, specificity and PPV data, we will begin to explore ways in which the ROCA could be implemented in clinical practice. The eventual clinical use will of course be informed and guided by the outcome of UKCTOCS and other clinical trials.”
 Lu KH, Skates S, Hernandez MA, et al. A 2-stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early-stage incident cancers and demonstrates high positive predictive value. Cancer. EPub 26 Aug 2013
2 Menon et al. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) Lancet Oncol; 10: 327–40. 2009.
Note to Editors:
1. ABOUT ABCODIA
Abcodia is a specialist company engaged in the developing biomarkers for the early detection of cancer. The company has developed deep expertise in the methods and technology relevant to the discovery and validation of biomarkers that can be detected well before the symptomatic presentation of cancer. Through an exclusive commercial license to the UKCTOCS biobank, the company is able to use samples from this population cohort to develop a pipeline of diagnostic products for the early detection of a range of cancers. Abcodia has received investment from Albion Ventures and UCL Business.
2. ABOUT UKCTOCS
UKCTOCS is the UK Collaborative trial of Ovarian Cancer Screening. It is coordinated by the Gynaecological Cancer Research Centre at the Institute of Women’s Health, UCL
Please contact Press Officer Ellee Seymour on +44 7939 811961
Posted: September 2013