Summary & Overview
CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay
CPT code 0003U identifies Overa™ (OVA1 Next Generation/MIA2G), a proprietary multivariate index assay for assessing ovarian cancer risk through measurement of five serum biomarkers combined with algorithmic patient-data analysis. As a PLA code tied to a specific manufacturer and laboratory, it standardizes reporting for this unique diagnostic service and supports claims processing and utilization tracking nationally. Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find a concise overview of the code’s clinical role in ovarian cancer risk assessment, expected service setting, and the payer landscape. The publication summarizes benchmark coverage patterns, coding and billing considerations tied to PLA designations, and relevant policy updates affecting laboratory testing and algorithmic assays. Clinical context describes the intended use of the assay (serum biomarker panel with algorithmic risk stratification) and implications for diagnostic workflows. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0003U is a Proprietary Laboratory Analyses (PLA) code that describes the Overa™ (OVA1 Next Generation), also called Multivariate Index Assay, 2nd Generation (MIA2G), produced by Aspira Labs, Inc. and Vermillion, Inc. The test is a biochemical assay of a serum specimen that measures five biomarker proteins and uses algorithmic analysis with patient data and laboratory results to determine a patient’s risk for ovarian cancer.
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Service type: Laboratory multivariate index assay using serum biomarker analysis and algorithmic risk calculation
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Typical site of service: Clinical laboratory or reference laboratory performing proprietary diagnostic testing
Clinical & Coding Specifications
Clinical Context
A 52-year-old woman presents to her gynecologist with new-onset pelvic discomfort and an adnexal mass identified on pelvic ultrasound. Serum CA-125 is indeterminate. The clinician orders the Overa™ (OVA1 Next Generation; MIA2G) proprietary multivariate index assay to assess the patient’s risk of ovarian malignancy prior to deciding on surgical referral. A phlebotomy draw of a serum specimen is performed in an outpatient lab or hospital outpatient collection area. The specimen is sent to the performing laboratory (Aspira Labs/Vermillion) for biochemical measurement of five protein biomarkers and algorithmic analysis incorporating patient data (e.g., menopausal status) to generate a risk score. Results are returned to the ordering provider to guide the decision for gynecologic oncology referral or conservative management.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default professional and technical components intact | Rarely used explicitly; denotes standard claim when no specific modifier applies |
26 | Professional component | Use if only the interpretation/professional component is billed separately by a physician (uncommon for PLA tests) |