HE4, Ovarian Cancer Monitoring

Test Code

CPT Codes

Preferred Specimen
0.5 mL serum

Minimum Volume
0.3 mL

Other Acceptable Specimens
Red top tube
SST (speckled top) tube

Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour.

Transport Container
Plastic screw cap vial

Transport Temperature

Specimen Stability
Room Temperature = 48 hours
Refrigerated = 72 hours
Frozen = 28 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Lipemia • Icteric specimens • Presence of fibrin, RBCs or other particulate matter • Obvious microbial contamination

Chemiluminescent Microparticle Immunoassay (CMIA)


A clinical study indicated that serial HE4 levels correlated with clinical status (progression vs. no progression) in 70% (247/354) of the study participants.

Reference Range
Female Premenopausal ≤70 pmol/L
Female Postmenopausal ≤140 pmol/L

Clinical Significance
The percentage increase in HE4 values has been used as an aid in monitoring recurrence or progressive disease in patients with invasive epithelial ovarian cancer. Currently there is no clinically accepted cut-off for use in monitoring cancer progression in epithelial ovarian cancer subjects with this assay. Serial testing for patient HE4 assay values should be used in conjunction with methods used for monitoring ovarian cancer.

Performing Laboratory
Quest Diagnostics Nichols Institute San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.