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Salvaging Detection of Early-Stage Ovarian Malignancies When CA125 Is Not Informative
Charles J Dunton1,2, Megan L Hutchcraft3, Rowan G Bullock1
1Aspira Women's Health, Inc., 12117 Bee Caves Road, Building III, Suite 100, Austin, TX 78738, USA.
Diagnostics (Basel, Switzerland)
|August 27, 2021
Summary
OVA1, a multivariate index assay, shows improved detection of ovarian cancer in patients with low CA125 levels, especially in premenopausal women and early-stage disease. This test aids in identifying at-risk tumors for timely referral and potentially better survival outcomes.
Area of Science:
- Gynecologic Oncology
- Biomarker Discovery
- Early Cancer Detection
Background:
- Ovarian cancer is a leading cause of death among gynecologic cancers, lacking effective screening methods.
- Serum Cancer Antigen 125 (CA125) is a common biomarker but has limitations in detecting early-stage or certain subtypes of ovarian cancer, particularly in premenopausal women.
- The multivariate index assay OVA1 combines CA125 with other serum proteins to improve the assessment of malignancy risk in adnexal masses.
Purpose of the Study:
- To evaluate the diagnostic performance of OVA1 in a cohort of patients presenting with low serum CA125 levels.
- To compare the efficacy of OVA1 against CA125 alone in identifying malignant potential in adnexal masses within this specific patient group.
Main Methods:
- Analysis of a cohort (N=2305) with CA125 levels below established thresholds (≤67 U/mL for premenopausal, ≤35 U/mL for postmenopausal women).
- Comparative assessment of OVA1 and CA125 performance metrics, including sensitivity, specificity, and predictive values for malignancy.
- Stratification of results based on menopausal status and ovarian cancer histology.
Main Results:
- OVA1 demonstrated an overall sensitivity of 59% with a 30% false-positive rate in patients with low CA125.
- The assay detected over 50% of ovarian malignancies in premenopausal women with low CA125 and identified 63% of early-stage cancers missed by CA125.
- OVA1 showed varying detection rates for different subtypes, including 83% for serous, 58% for mucinous, and 50% for clear cell carcinomas, despite low CA125 levels.
Conclusions:
- CA125 alone misses a significant proportion of ovarian malignancies, highlighting the value of OVA1 as a supplementary tool.
- OVA1 is particularly beneficial for premenopausal women and early-stage ovarian cancers, where CA125 is less reliable.
- Utilizing OVA1 in patients with normal CA125 levels can improve the identification of high-risk ovarian tumors, facilitating timely referral to gynecologic oncologists and potentially enhancing patient survival rates.
