FDA Clears Abbott’s Test to Monitor Ovarian Cancer

Architect HE4 uses serum samples to detect the level of HE4 antigen.

FDA approved Abbott Laboratories’ diagnostic test to monitor ovarian cancer. The Architect HE4 (human epididymis protein 4) assay uses a blood sample to monitor for the recurrence or progression of ovarian cancer.

It is the first automated test of its kind available in the U.S., according to Abbott. The firm partnered with Fujirebio Diagnostics to develop the assay, which is also approved for use in Europe as well as in countries in Asia Pacific and Latin America. The Architect HE4 assay is a chemiluminescent microparticle immunoassay for the quantitative determination of HE4 antigen in human serum.

The current most widely used test to monitor ovarian cancer, CA125, measures levels of a protein in the blood as an indication of a possible recurrence or disease progression. However, 20% of all ovarian cancers do not express CA125, according to Abbott. The HE4 test in conjunction with other clinical methods including CA125 is thus expected to give physicians a more comprehensive clinical picture when monitoring ovarian cancer patients.

Abbott cites a 2003 paper published in Cancer Research of known ovarian cancer biomarkers. The study found that HE4 had the highest sensitivity and specificity of any other marker and is considered the best single marker for stage 1 of the disease, according to the company. The research team reported in its paper that “blinded studies on sera from postmenopausal patients with ovarian carcinoma and controls indicate that the specificity and sensitivity of the HE4-based ELISA is equivalent to that of the CA125 assay. However, the HE4 assay may have an advantage over the CA125 assay in that it is less frequently positive in patients with nonmalignant disease.”