CPT Code 0003U | Description & Clinical Information

CPT 0003U describes a proprietary laboratory analyses (PLA) code for the Overa™ (OVA1 Next Generation), also known as Multivariate Index Assay, 2nd Generation (MIA2G), developed by Aspira Labs, Inc. and Vermillion, Inc., which is a biochemical assay of a serum specimen that detects the presence of five biomarker proteins for ovarian cancer, and includes algorithmic analysis using patient data and lab test results to determine the patient’s risk for ovarian cancer.

Official Description

The CPT book defines CPT code 0003U as: “Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score”.

Clinical Information

The procedure described by CPT code 0003U is a laboratory test that aims to determine a patient’s risk for ovarian cancer. The test involves testing the patient’s serum for five biomarkers using an immunoassay method. The biomarkers are apolipoprotein A1 (APO), CA 125 II, follicle-stimulating hormone (FSH), human epididymis protein 4 (HE4), and transferrin (TRF). The lab analyst performs the technical steps, which can include several steps such as reacting the specimen with test antibodies, incubating the mixture, adding microparticles to bind the complexes to an electrode, and applying an electric charge to initiate luminescence.

The immunoassay method determines the presence or absence of a substance in the specimen, which the analyst then reports as qualitative results. These results serve as the raw data for the MAAA test’s algorithmic analysis, a proprietary algorithm that combines the five biomarkers’ results with clinical assessment into a single numerical risk score. The risk score indicates the patient’s higher or lower risk for ovarian cancer.

The MAAA test is not limited to immunoassay methods. It includes any analytical services that produce the test’s raw data for the algorithmic analysis. These technical lab services may take various forms, including chemical or biochemical assays, fluorescence in situ hybridization (FISH), and molecular pathology tests. Examples of these are cell lysis, extraction, amplification, and hybridization/detection.

The MAAA code also includes gathering relevant patient data, carrying out algorithmic analysis, and reporting the results. A clinician might order the MAAA test to determine a patient’s risk for ovarian cancer. The risk score provides guidance to the clinician in describing the patient’s risk level, prompting the clinician to determine the next steps and management. Thus the MAAA test contributes significantly to the personalized and precise care that clinicians aim to deliver to their patients.

Return to all the CPT codes for proprietary laboratory analyses.