Fujirebio Diagnostics receives FDA 510(k) clearance for Risk of Ovarian Malignancy Algorithm test

Fujirebio Diagnostics, the industry leader in oncology biomarker assays, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's HE4 Test in an algorithm called ROMA™ (HE4 EIA + ARCHITECT CA 125 II™) to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.  

The ROMA (Risk of Ovarian Malignancy Algorithm) test uses the results from simple blood tests, CA 125 and HE4, to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery. HE4 has been shown to be elevated in epithelial ovarian cancers (EOC), the most common type of ovarian cancer, but is not elevated in many benign gynecologic diseases. Combining physician assessment with the independently validated ROMA algorithm enables physicians to identify those patients at high likelihood of malignancy who should have their surgery performed by a gynecologic oncologist.

"Using ROMA with HE4 and CA 125 significantly improves our ability to identify women who are at high or low likelihood of ovarian cancer when they present with an ovarian cyst or mass," said Richard G. Moore, MD, Associate Professor of Obstetrics and Gynecology at the Alpert School of Medicine at Brown University and Director of the Center for Biomarkers and Emerging Technologies in the Program for Women's Oncology at Women and Infants' Hospital in Providence, RI. "Patients who have ovarian cancer have better outcomes when their surgery is performed by a gynecologic oncologist at centers experienced in the management of this disease. This combination test will allow physicians to identify those patients who should be treated by a gynecologic oncologist and equally important allow women with benign disease to stay in their communities with the physician who knows them best. It will change the way doctors diagnose and treat ovarian cancer," added Dr. Moore, who is the lead researcher for the team that developed ROMA and author of two multi-center studies investigating the use of HE4 and CA 125 and ROMA.

Ovarian cancer is recognized as difficult to diagnose because its symptoms are easily confused with other non-cancerous conditions. Three quarters of cases of ovarian cancer are diagnosed at an advanced stage, when it is more difficult to treat. Of patients who are diagnosed early (Stage I-II), more than 90 percent will live past five years.  However, only one quarter of cases are diagnosed in the early stages.

"The clearance of ROMA is a major advance for the gynecologist and will become an important component of the preoperative assessment of women presenting with a pelvic mass," said Lee P. Shulman, MD, Professor of Obstetrics and Gynecology, Chief of the Division of Clinical Genetics and Co-Director of the National Ovarian Cancer Early Detection Program at Northwestern University.

There is a vast body of published, multinational, peer-reviewed clinical evidence supporting the use of the HE4 test in combination with the CA 125 test. To date there have been nine original peer reviewed publications validating the performance of ROMA in populations as diverse as Korean, Chinese, Italian, Dutch, and American. Its utility as a stratification tool is supported by results from a prospective, double-blind, multicenter trial involving 472 women with pelvic mass who were scheduled for surgical intervention.

Data from a study of 472 patients presented at this year's annual meeting of the Society of Gynecologic Oncologists and published in the August 2011 issue of Obstetrics and Gynecology, the journal of the American Congress of Obstetricians and Gynecologists show that ROMA alone was highly accurate in assigning a combined pre- and postmenopausal patient population to likelihood groups, with 93.8 percent of EOCs correctly classified as high likelihood. Looking at the postmenopausal group, ROMA had a sensitivity of 92.3%, a specificity of 76.0%, and a negative predictive value (NPV) of 97.4%.  Looking at the premenopausal group, ROMA had a sensitivity of 100%, a specificity of 74.2%, and an NPV of 100%.  

Data from a study of 462 patients reviewed by the FDA and published in the Instructions for Use for the test show that, when combined with the methods a physician would normally use to assess likelihood of ovarian cancer in a combined pre- and postmenopausal patient population, ROMA had a sensitivity of 88.4%, a specificity of 67.2% and an NPV of 96.2%.

"The ROMA test, by improving the sensitivity of methods used to stratify patients with an adnexal mass who are already scheduled for surgery, is expected to help thousands of physicians determine their patient's likelihood for ovarian cancer and enable those who are at high likelihood to be referred to a gynecologic oncologist – a benefit that will improve treatment outcomes," said Paul Touhey, President and Chief Executive Officer of Fujirebio Diagnostics. "With this increased ability to improve referral patterns, as well as a price that is comparable to CA 125 testing, the health care costs involved with cancer diagnosis and treatment should decrease significantly."