What are the benefits and potential negative effects of ordering an Ova-1 (Ovarian Cancer Test) for an elderly female with an ovarian mass?

OVA-1 Testing in an 83-Year-Old Female with Ovarian Mass

The OVA-1 test should not be ordered for this patient, as major professional societies including NCCN and the Society of Gynecologic Oncologists explicitly recommend against its use for determining the status of an undiagnosed pelvic mass. 1

Why OVA-1 is Not Recommended

Guideline-Based Contraindications

• The NCCN panel specifically states that OVA-1 increases cost without providing much benefit and raises concerns about false-positive results 1
• The Society of Gynecologic Oncologists and FDA jointly state that OVA-1 should not be used as a screening tool to detect ovarian cancer 1
• The test is not FDA-approved as a screening test for ovarian cancer 1

Superior Alternative Approach

Instead of OVA-1, use the ACOG/SGO criteria to determine whether referral to a gynecologic oncologist is warranted 1:

For postmenopausal women (which includes your 83-year-old patient), refer if ANY of the following are present:

• Elevated CA-125 (>35 U/mL)
• Nodular or fixed pelvic mass on examination
• Evidence of metastatic disease or ascites
• Family history of breast or ovarian cancer 1

Potential Negative Effects of Ordering OVA-1

Direct Harms from False-Positive Results

• False-positive results are common and lead to unnecessary anxiety in otherwise healthy women 1
• The positive predictive value of ovarian cancer screening tests is only approximately 2% in average-risk women, meaning 98% of positive tests are false positives 1
• False-positive results trigger additional invasive testing and potentially unnecessary surgery 1

Surgical Complications in Elderly Patients

This is particularly critical for an 83-year-old patient, as elderly women face substantially higher surgical risks:

• In women over 80 undergoing ovarian cancer surgery, 38% experience major postoperative morbidity including congestive heart failure, sepsis, and aspiration pneumonia 2
• Postoperative mortality occurs in approximately 12.5% of patients over 80 years old 2
• 75% of elderly surgical patients require intensive care unit admission, with median stays of 3 days 2
• 35% of elderly patients cannot be discharged home and require intermediate care facilities or nursing homes 2

Financial and Resource Burden

• OVA-1 adds unnecessary cost without clinical benefit 1
• The test requires additional CA-125 testing anyway, as OVA-1 does not provide individual biomarker levels 1

What Should Be Done Instead

Appropriate Initial Workup

Order CA-125 as the primary serum biomarker 1, 3:

• CA-125 has nearly 100% specificity when using thresholds of 30-35 U/mL 1
• In postmenopausal women over 50, CA-125 has 98.5% specificity 4

Obtain transvaginal ultrasonography to characterize the mass 3:

• Assess for solid components, papillary projections, septations, and vascularity patterns 4
• Use O-RADS classification system for risk stratification 4, 5

Complete metabolic panel including liver and renal function tests 3

Complete blood count to assess for anemia 3

Age-Specific Considerations

For an 83-year-old patient, recognize that:

• Ovarian cancer incidence is 54.8 per 100,000 for women ≥65 years versus 9.4 per 100,000 for those under 65 6
• Older women have dramatically worse survival rates even after adjustment for general life expectancy, with 5-year relative survival of only 8% for women ≥85 years with Stage III-IV disease 6
• Older women are treated less aggressively and have poorer outcomes 6

Critical Pitfall to Avoid

Do not rely on any multimarker panel (including OVA-1) when established clinical criteria (ACOG/SGO) and standard testing (CA-125 plus ultrasound) provide superior evidence-based guidance 1. The decision to refer to a gynecologic oncologist should be based on ACOG/SGO criteria, not on proprietary multimarker assays that lack validation and professional society endorsement.