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BETA v.3.0

2025 CPT code 86305

Human epididymis protein 4 (HE4) assay.

Not to be used for initial diagnosis of ovarian cancer; Not recommended for monitoring mucinous or germ cell ovarian cancers.

Modifiers 90 (Reference [Outside] Laboratory), 91 (Repeat Clinical Diagnostic Laboratory Test) may be applicable.

Medically necessary for monitoring treatment response or recurrence of epithelial ovarian cancer, or for assessing the risk of ovarian malignancy in women with pelvic masses.

Laboratory professionals perform the HE4 assay using immunoassay methods like electrochemiluminescence. They react the patient sample with antibodies, incubate, bind complexes to an electrode, and measure the resulting luminescence.

IMPORTANT:Use in conjunction with CA-125 (86304).

In simple words: The HE4 test measures the amount of a protein called HE4 in your blood.Doctors use this test, along with other tests like the CA-125, to help keep track of ovarian cancer treatment and to see if the cancer has come back after treatment. It can also help determine if a pelvic mass is cancerous.

This test quantifies human epididymis protein 4 (HE4) in serum or body fluid. HE4 is a tumor marker primarily used in conjunction with CA-125 to monitor epithelial ovarian cancer treatment response and recurrence, and to assess the risk of ovarian malignancy in patients with pelvic masses.

Example 1: A woman with a history of epithelial ovarian cancer has regular HE4 tests along with CA-125 tests to monitor for recurrence., A woman with a pelvic mass undergoes HE4 and CA-125 testing as part of a Risk of Ovarian Malignancy Algorithm (ROMA) assessment., A woman diagnosed with epithelial ovarian cancer has a baseline HE4 test performed to establish a reference point for monitoring treatment response.

Diagnosis of epithelial ovarian cancer; Reason for testing (e.g., monitoring treatment response, recurrence surveillance, ROMA assessment); Date and time of specimen collection; Specimen source (e.g., serum, body fluid).

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