Abbott Labs before the end of the year plans to debut its Architect HE4 assay, which is designed to help oncologists monitor patients with epithelial ovarian cancer, the most common form of the disease. [The company recently submitted] the immunoassay for regulatory approval with FDA. The company is betting the blood-based assay will be indicated to help docs "monitor for the recurrence or progression" of epithelial ovarian cancer. The test, currently an investigational device in the US, is expected to be "the first automated HE4 test available in US," according to Abbott....The HE4 biomarker is known to exist at "high levels in the blood of some ovarian cancer patients" and is believed to offer what Abbott calls "the highest sensitivity and specificity of any other marker" for the disease. It is also considered to be one of the best single markers for stage 1 of the disease....According to Abbott, because certain types of ovarian cancers "rarely express HE4," the Architect HE4 "should not be used as a cancer screening test." Rather is designed "to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data." According to Quest, CA 125 is "currently the serum marker most widely used to monitor therapeutic response and to detect disease recurrence in patients treated for epithelial ovarian cancer."
If HE4 can only be used as an ovarian cancer monitoring test and not a screening test, why would Abbot develop an automated version of it? The number of patients being monitored for cancer progression or recurrence is relatively small when compared to other more female neoplastic disease such as breast cancer. Moreover, HE4 would need to compete with another better established test, CA 125, for this specialized test business. However, it may be possible that the company anticipates that the assay HE4 may, in time, have a much broader application.
As noted above, HE4 is only of value for monitoring epithelial ovarian cancer. Epithelial ovarian cancer is the most lethal form of gynecologic cancer and the fourth leading cause of cancer death among women in developed countries, claiming about 15,000 lives in the United States each year (see: Early detection of ovarian cancer using group biomarkers ). The two other major types of ovarian cancer are germ cell and stromal cell tumors. Because these latter lesions are derived from different ovarian cell types, they do not express the same antigens as the epithelial tumors. Perhaps we should anticipate the emergence of a set of biomarkers, an IVDMIA , that can reliably identify all three cancer types at an early stage and therefore have utility for broad ovarian screening programs.