A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. Materials & methods: This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. Results: Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. Conclusion: This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.
Supplementary Material
File (supplementary data.docx)
- Download
- 33.23 KB
References
1.
Ovarian Cancer Research Fund Alliance. Statistics. http://www.ocrfa.org/members/about-ovarian-cancer/statistics/
2.
Torre LA, Trabert B, DeSantis C et al. Ovarian cancer statistics, 2018. CA Cancer J. Clin. 68(4), 284–296 (2018).
3.
Zhang Z, Bullock RG, Fritsche H. Adnexal mass risk assessment: a multivariate index assay for malignancy risk stratification. Future Oncol. 15(33), 3783–3795 (2019).
4.
Glanc P, Benacerraf B, Bourne T et al. First international consensus report on adnexal masses: management recommendations: international consensus on adnexal masses. J. Ultrasound Med. 36(5), 849–863 (2017).
5.
Surveillance, Epidemiology, and End Results Program (SEER). National Cancer Institute. Cancer stat facts: ovarian cancer. https://seer.cancer.gov/statfacts/html/ovary.html
6.
American College of Obstetricians and Gynecologists. ACOG practice bulletin. Management of adnexal masses. Obstet. Gynecol. 128, 1193–1195 (2016).
7.
Longoria RS, Ueland FR, Zang Z et al. Clinical performance of a multivariate index assay for detecting early-stage ovarian cancer. Am. J. Obstet. Gynecol. 210(1), P78.E1–P78.E9 (2014).
8.
Coleman RL, Herzog TJ, Chan DW et al. Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses. Am. J. Obstet. Gynecol. 215(1), 82.e1–82.e11 (2016).
9.
Brodsky BS, Owens GM, Scotti DJ et al. Economic impact of increased utilization of multivariate assay testing to guide the treatment of ovarian cancer: implications for payers. Am. Health Drug Benefits 10(7), 351–359 (2017).
10.
Bristow RE, Smith A, Zhang Z et al. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol. Oncol. 128(2), 252–259 (2013).
11.
Ueland FR, Desimone CP, Seamon LG et al. Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstet. Gynecol. 117(6), 1289–1297 (2011).
12.
Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. Advances in ovarian cancer therapy. Cancer Chemother. Pharmacol. 81(1), 17–38 (2018).
13.
Springer S, Masica DL, Dal Molin M et al. A multimodality test to guide the management of patients with a pancreatic cyst. Sci. Transl. Med. 11(501), eaav4772 (2019).
14.
Department of Health & Human Services. Food and Drug Administration. https://www.accessdata.fda.gov/cdrh_docs/reviews/k081754.pdf
15.
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins – Gynecology. Practice bulletin no. 174: evaluation and management of adnexal masses. Obstet. Gynecol. 128(5), e210–e226 (2016).
16.
Dearking AC, Aletti GD, McGree ME et al. How relevant are ACOG and SGO guidelines for referral of adnexal mass? Obstet. Gynecol. 110(4), 841–848 (2007).
17.
Shaw R, Lokshin AE, Miller MC, Messerlian-Lambert G, Moore RG. stacking machine learning algorithms for biomarker-based preoperative diagnosis of a pelvic mass. Cancers 14(5), 1291 (2022).
18.
Rothwell, Peter M. Factors that can affect the external validity of randomised controlled trials. PLOS Clin. Trials 1(1), e9 (2006).
Information & Authors
Information
Published In
Copyright
© 2023 The authors. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 13 February 2023
Accepted: 2 May 2023
Published online: 22 May 2023
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk. (2023) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2023-0025
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Nisha Singh, Deepshikha Rajput, Evaluation of Adnexal Mass in Menopause, Menopause Essentials, 10.1007/978-981-95-7498-8_19, (295-312), (2026).
- Jim Åkerrén Ögren, Joakim Ekström, Natallia Rameika, Emma Torell, Chatarina Larsson, Ivaylo Stoimenov, Patrick Micke, Ulf Gyllensten, Mats Hellström, Bengt Glimelius, Karin Stålberg, Tobias Sjöblom, Composite proteomic and metabolomic plasma biomarkers for detection of colorectal, lung and ovarian cancers, Molecular Cancer, 10.1186/s12943-026-02654-1, 25, 1, (2026).
- Mehran Molavand, Amir Valizadeh, Bahman Yousefi, Maryam Majidinia, Ovarian cancer detection and prognosis: Unveiling circRNAs potential, Clinica Chimica Acta, 10.1016/j.cca.2025.120793, 582, (120793), (2026).
- Noa Rappaport, Bartek Nogal, Kevin Perrott, Vincenzo Domina, Leroy Hood, Nathan D. Price, Early Detection of Wellness-to-Disease Transitions in the AI Era: Implications for Pharmacology and Toxicology, Annual Review of Pharmacology and Toxicology, 10.1146/annurev-pharmtox-062124-013423, 66, 1, (41-64), (2026).
- William C. Cho, An interview with William Cho, Expert Review of Proteomics, 10.1080/14789450.2025.2602751, 22, 11-12, (441-446), (2025).
- Charlotte Adams, Wout Bittremieux, A 2025 perspective on the role of machine learning for biomarker discovery in clinical proteomics, Expert Review of Proteomics, 10.1080/14789450.2025.2545828, 22, 10, (363-374), (2025).
- Mikaela Moskov, Julia Hedlund Lindberg, Maria Lycke, Emma Ivansson, Ulf Gyllensten, Karin Sundfeldt, Karin Stålberg, Stefan Enroth, Deep plasma proteomics identifies and validates an eight-protein biomarker panel that separate benign from malignant tumors in ovarian cancer, Communications Medicine, 10.1038/s43856-025-00945-0, 5, 1, (2025).
- Panagiota S. Filippou, Priyanka Dey, Proteomic Biomarkers and Diagnostic Tools in Ovarian Cancer: Understanding Their Clinical Value and Limitations, Journal of Proteome Research, 10.1021/acs.jproteome.5c00088, 24, 7, (3137-3153), (2025).
- S.N. Naryzhny, O.K. Legina, Selection of optimal protein sets as serological tumor marker signatures, Biomeditsinskaya Khimiya, 10.18097/PBMCR1552, 71, 3, (163-194), (2025).
- Emma Ivansson, Julia Hedlund Lindberg, Karin Stålberg, Karin Sundfeldt, Ulf Gyllensten, Stefan Enroth, Large-scale proteomics reveals precise biomarkers for detection of ovarian cancer in symptomatic women, Scientific Reports, 10.1038/s41598-024-68249-2, 14, 1, (2024).
- See more
