A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk.

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.

Validation of a deep neural network-based algorithm supporting clinical management of adnexal mass.

Background: Conservative management of adnexal mass is warranted when there is imaging-based and clinical evidence of benign characteristics. Malignancy risk is, however, a concern due to the mortality rate of ovarian cancer. Malignancy occurs in 10-15% of adnexal masses that go to surgery, whereas the rate of malignancy is much lower in masses clinically characterized as benign or indeterminate. Additional diagnostic tests could assist conservative management of these patients. Here we report the clinical validation of OvaWatch, a multivariate index assay, with real-world evidence of performance that supports conservative management of adnexal masses. Methods: OvaWatch utilizes a previously characterized neural network-based algorithm combining serum biomarkers and clinical covariates and was used to examine malignancy risk in prospective and retrospective samples of patients with an adnexal mass. Retrospective data sets were assembled from previous studies using patients who had adnexal mass and were scheduled for surgery. The prospective study was a multi-center trial of women with adnexal mass as identified on clinical examination and indeterminate or asymptomatic by imaging. The performance to detect ovarian malignancy was evaluated at a previously validated score threshold. Results: In retrospective, low prevalence (N = 1,453, 1.5% malignancy rate) data from patients that received an independent physician assessment of benign, OvaWatch has a sensitivity of 81.8% [95% confidence interval (CI) 65.1-92.7] for identifying a histologically confirmed malignancy, and a negative predictive value (NPV) of 99.7%. OvaWatch identified 18/22 malignancies missed by physician assessment. A prospective data set had 501 patients where 106 patients with adnexal mass went for surgery. The prevalence was 2% (10 malignancies). The sensitivity of OvaWatch for malignancy was 40% (95% CI: 16.8-68.7%), and the specificity was 87% (95% CI: 83.7-89.7) when patients were included in the analysis who did not go to surgery and were evaluated as benign. The NPV remained 98.6% (95% CI: 97.0-99.4%). An independent analysis set with a high prevalence (45.8%) the NPV value was 87.8% (95% CI: 95% CI: 75.8-94.3%). Conclusion: OvaWatch demonstrated high NPV across diverse data sets and promises utility as an effective diagnostic test supporting management of suspected benign or indeterminate mass to safely decrease or delay unnecessary surgeries.