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Abbott, Fujirebio Co-Developing HE4/CA125 Dx to Improve Early Ovarian Cancer Detection


By Turna Ray

Abbott and Fujirebio Diagnostics plan to co-develop a new diagnostic test for the early detection of ovarian cancer that gauges levels of the protein serum CA125 and the human epididymal protein 4, or HE4, Abbott said last week.

Fujirebio Dx received clearance from the US Food and Drug Administration last June for a manual form of the HE4 test. The blood-based test is approved in the US to help monitor recurrent or progressive early-stage ovarian cancer. This test also has CE marking within the European Union to help predict which premenopausal and postmenopausal women are at increased risk for developing epithelial ovarian cancer.

Abbott manufactures a CA125 test, which is widely used for monitoring ovarian cancer. Although CA125 is used to monitor response to therapy and recurrent disease in early-stage breast cancer patients, serum protein levels are not elevated in 20 percent of patients.

By combining HE4 with CA125 detection capabilities in a single test, Abbott hopes to improve doctors' ability to identify women at risk for ovarian cancer.

"The HE4 test was developed through research efforts aimed at identifying combinations of biomarkers to add sensitivity to the CA125 test, which is limited in its sensitivity and specificity, as well as its ability to monitor early stage epithelial ovarian cancer," Abbott said in a statement.

Abbott presented clinical trial data at the American Association for Clinical Chemistry's annual meeting last week regarding this multi-marker test.

Researchers led by Olle Nilsson, VP of Business Development at Fujirebio Diagnostics, conducted a retrospective study using serum 434 samples from 80 patients either undergoing treatment for or being monitored for early-stage ovarian cancer recurrence.

"The objective of this study was to determine the concordance between changes in serum levels of HE4 and CA125 in monitoring of patients with EOC and the possible complementary use of HE4," the study authors explain in the abstract.

In the study, researchers established the clinical status of study patients by testing their CA125 levels and through CT imaging, and documented whether ovarian cancer progressed, regressed, or was absent in these patients. Researchers then compared the clinical concordance of the documented clinical status and changes in serum CA125 and HE4 levels.

In the study, CA125 and HE4 levels were measured using Abbott's Architect CA 125II assay and Fujirebio Dx's HE4 EIA assay.

"HE4 follow the clinical course of disease in the majority of patients with early-stage ovarian cancer and behaves in concordance with CA125 in the majority of patients," the researchers concluded in the abstract. "Both markers complement each other and HE4 may provide information on disease status in patients where CA125 is not of clinical utility."

The AUCs for percent-change of HE4 and CA125 and clinical progression were not statistically different for the two markers, according to the study authors. CA125 and HE4 levels correlated in 91 percent and 93 percent of patients whose disease progressed.

In patients where CA125 did not correlate with clinical status, HE4 correlated in 23 percent of patients. Meanwhile, in patients where HE4 did not correlate with clinical status, CA125 correlated in 32 percent of patients.

HE4 is a cancer biomarker in the Whey acidic Four Disulphide Core (WFDC) protein family of putative protease inhibitors.

"More than 250,000 women present to their physician each year with a suspicious pelvic mass, yet there is still no reliable tool to differentiate malignant disease from other benign gynecologic conditions, making early detection a significant challenge," Robert Doss, divisional vice president, research and development at Abbott Diagnostics, said in the statement last week. "HE4 represents an important advancement in monitoring these pelvic masses."

According to Richard Moore, one of the study authors and associate professor of the women's oncology program at Brown University, the clinical trial "show that the dual marker combination of HE4 and CA125 can aid in the differentiation of benign pelvic masses from ovarian malignancies in women diagnosed with a pelvic mass."

Ovarian cancer is the fifth-leading cause of cancer death among women in the US. According to estimates from the American Cancer Society nearly 21,550 women will be newly diagnosed with ovarian cancer this year and approximately 14,600 women will die from it. Post-menopausal women are at greatest risk of developing the disease.