Learn about the terminology and performance measures to determine the accuracy of a diagnostic test.
|Product||Early Stage (Stage I and II)||Pre-menopausal Early Stage||Post-menopausal Early Stage|
What is the difference between OVA1 and ROMA?1,2,3
ROMA and OVA1 (MIA) have the same FDA intended use. Both tests are used to assess the cancer risk of adnexal masses prior to surgery and must be interpreted in conjunction with an independent clinical and radiological assessment and are not intended as a screening or stand-alone diagnostic assay. However, the performance of the two tests are different.
This can be demonstrated in a side-by-side view of individual validation studies and third party head-to-head comparisons.
|Product||Ov Ca Subtypes||(n)||Prevalence||Sensitivity||Specificity||PPV||NPV|
|ROMA (Moore et al. 2011)||All ovarian cancers||472||18.9%||80.9%||74.9%||42.9%||94.4%|
|OVA1 (Bristow et al. 2013)||All ovarian cancers||494||18.6%||92.4%||53.5%||31.3%||96.8%|
OVA1 (MIA) has strong evidence of high sensitivity across a broad range of subtypes. This is clearly characterized in non-epithelial ovarian cancers, LMPs, metastases and other malignancies.
Head-to-head comparison study4
Grenache et al. 2015 evaluated both OVA1 (MIA) and ROMA in all samples which included 31 surgically confirmed malignancies in 146 adnexal masses. The results showed that OVA1 (MIA) had higher sensitivity, which allows optimal distribution of cancers to specialists and confidence in managing negative tests as they were more likely benign cases.
|ROMA||Cancers Missed||Sample Size (n)|
|Advanced Ovarian Cancer||7%||54|
|High-grade Serous Subtype||6%||58|
|Clear Cell Subtype||30%||11|
- Moore RG et al., Obstet Gynecol. 2011 Aug;118(2 Pt 1):280-8.
- Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
- Longoria TC, et al., Am J Obstet Gynecol. 2014 Jan;210(1):78.e1-9
- Grenache DG, et al., Clin Chim Acta. 2015 Jan 1;438:358-63.
- Lennox GK et al., Int J Gynecol Cancer. 2015 Jun;25(5):809-14.
- American Congress of Obstetricians and Gynecologists, Practice Bulletin 174; 2016 Nov