HE4, Ovarian Cancer Monitoring

Test Code
16500

CPT Codes
86305

Preferred Specimen
0.5 mL serum

Minimum Volume
0.3 mL

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

Instructions
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

Red-top tube (no gel)



Transport Temperature
Frozen

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

Methodology
Chemiluminescent Microparticle Immunoassay (CMIA)

Limitations

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.



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.