Test Directory

4321 HE4 Ovarian Cancer Marker

Specimen Type
Specimen Stability
Reference Range
Serum
Transport tubes at Ambient temperature or Refrigerated. Samples should be Refrigerated if not tested immediately. Freeze samples at or below -20C° if the sample is not assayed within 7 Days.
<150 pM

Specimen Requirements

Preferred Specimen: Serum
Container: 1 Serum Separator Tube (SST)
Temperature: Refrigerated
Preferred Vol: 1.00 mL
Min Vol: 0.50 mL
  or
Alternate Specimen: Serum
Container: 1 Red Top Tube
Temperature: Refrigerated
Preferred Vol: 1.00 mL
Min Vol: 0.50 mL

Method

Test performed using Fujirubio Diagnostics, Inc. HE4 enzyme immunometric assay

Schedule

Mon, Thurs

Turn-Around Time

1-3 days (except weekends)

Instructions/Notes

Clinical Utility

HE4 is a tumor marker that can complement CA 125 for monitoring recurrence or progression of ovarian cancer. Elevated HE4 levels are associated with ovarian cancer but are not specific for the disease, and therefore the assay should not be used for screening. A change in HE4 level of >25% is considered significant. (package insert Fujirubio Diagnostics 2008). An increase of >25% suggests disease progression or recurrence. Serial testing of HE4 results should be used in conjunction with other clinical methods for monitoring ovarian cancer. HE4 is less sensitive/specific in mucinous or germ-cell ovarian cancer. The combination of HE4 and CA 125 serology might increase sensitivity and specificity for the detection of early ovarian cancer.
Values obtained with different assay methods should not be used interchangeably.
Tumor Biol 2011;32:1087-95.

CPT Codes

86305

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