Medical Device Daily

Doctors may soon be able to detect ovarian cancer in its earliest, most curable, stage by testing patients for elevated levels of a substance called HE4 in their blood.

Women with elevated levels of HE4 in their blood may be more likely to have ovarian cancer, according to results of a prospective study recently published online in Gynecologic Oncology.

"Ovarian cancer is often difficult to diagnose because symptoms are often recognized in the late stages of the disease when ovarian cancer is fundamentally incurable," said Richard Moore, MD, lead researcher of the study and an assistant professor in Women's Oncology at Women and Infants' Hospital and Brown University (Providence, Rhode Island). "Our research was directed at identifying those unique characteristics or biomarkers of the disease that might one day help us detect this disease earlier."

The study was supported by Fujirebio Diagnostics (Malvern, Pennsylvania), a company that has developed a manual test for HE4 and says it will be developing automated formats of the test for Fujirebio instruments, as well as, the Abbott Architect.

"This is the first individual marker that's been shown to really improve upon the performance of CA-125," David Swartz, director of marketing for Fujirebio, told Medical Device Daily.

He said the company expects the test to receive FDA clearance in the first half of 2008 and the CE-mark in February.

Swartz said the current gold standard for monitoring ovarian cancer is a test that measures for elevated levels of the CA-125 substance in the blood. According to Fujirebio, that test can be limited in detecting all types of ovarian cancer, prompting researchers to seek out additional biomarkers that offer higher sensitivity and can be indicative of the disease to complement CA-125.

"Our goal is that the test will ultimately be used in combination with CA-125 as an algorithm to predict the risk of ovarian cancer in women presenting with a pelvic mass," Swartz said.

Monte Wiltse, VP of sales and marketing for Fujirebio, told MDD that the assay will give gynecologic oncologists more confidence in determining the most appropriate treatment regimen for their patients.

Fujirebio reported receiving notification of allowance for the first family of patents for its HE4 biomarker in June.

In the study, Moore's team evaluated nine potential biomarkers in 259 patients with pelvic mass. Researchers measured levels of each biomarker within the women's blood and then compared the results with biopsies of their tumors. With 72.9% sensitivity and 95% specificity, HE4 was the most effective biomarker for detecting ovarian cancer. When CA-125 was added, the result was an even more powerful combination of tests with sensitivity for detecting the disease increased to 76.4%, the company said.

"Our results show testing women suspected of ovarian cancer for both CA-125 and HE4 could possibly lead to a screening and diagnostic tool," Moore said. "This is exciting news, particularly for women in the earliest stages of the disease when it is most treatable."

Moore's study noted HE4 as the best single marker for Stage I disease. About 70% to 75% of ovarian cancers are diagnosed at a late stage when the five-year overall survival rate may only reach up to 50%. However, in women diagnosed with Stage I disease, the probability of cure approaches 90% to 95%, Fujirebio said.

"This is an encouraging development not only for ovarian cancer patients, but for all women with ovarian cysts as it can be challenging to distinguish malignant tumors from benign ones with current methods," said Olle Nilsson, PhD, VP and CSO of Fujirebio. "A combination of tests could help clinicians better define ovarian cysts so they can determine the most appropriate treatment regimen for their patients."

Fujirebio develops in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

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