Ovarian cancer is a stealthy disease, hiding behind a cadre of non-specific symptoms. The ninth most common cancer in women, it ranks as the fifth leading cause of cancer death in women. Abbott (Abbott Park, Illinois) has submitted an application for FDA approval of a new diagnostic tool that can be used to monitor patients for the most common form of ovarian cancer.
The Architect HE4 assay uses a simple blood test to monitor for the recurrence or progression of epithelial ovarian cancer. If approved, this important immunoassay would be the first automated HE4 test available in the U.S.
"The Architect HE4 assay is a two-step immunoassay for the detection of the HE4 antigen in human serum," Beth Schodin, PhD, manager of Global Scientific Affairs at Abbott, told Medical Device Daily. "The test uses chemiluminescent technology and measures the Relative Light Units (RLUs) of the reaction in the sample. A direct relationship occurs between the amount of HE4 antigen in the sample and the RLUs detected by the Architect instrument."
A 2003 study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows 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 American Cancer Society, the five-year survival rate of ovarian cancer patients is 46%. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93%. Less than 20% of all ovarian cancer is found in the early stage.
"The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The Architect HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease," said Michael Warmuth, senior VP of diagnostics at Abbott.
Fujirebio Diagnostics (Malvern, Pennsylvania) and Abbott are working under a license agreement to develop this new ovarian cancer marker for use on Abbott's automated Architect diagnostic analyzers.
A manual form of the HE4 test has been approved by the FDA as an aid in monitoring recurrence or progressive disease in patients with EOC and is CE marked for use within the European Union as a diagnostic test (MDD, July 27, 2009). The indication in the U.S. will be different – as a monitor of disease progression or recurrence.
"Upon approval, the Architect HE4 assay is to be used as an aid in the monitoring of ovarian cancer, in conjunction with other clinical methods, such as biopsy or any imagining testing used for monitoring for cancer," Schodin 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.
But women with elevated levels of HE4 in their blood may be more likely to have ovarian cancer, according to results of a prospective study published in Gynecologic Oncology and sponsored by Fujirebio.
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. (MDD, Dec. 19, 2007).
Lynn Yoffee; 770-361-4789