MALVERN, Pennsylvania, June 6, 2011 /PRNewswire/ --

- Fujirebio Diagnostics' ROMA(TM) (HE4 + CA125) Test is Validated in the Italian Population

A study recently published online in the journal Clinica Chimica Acta validated the use of the HE4 test and the ROMA (Risk of Ovarian Malignancy Algorithm) algorithm in distinguishing malignant from benign pelvic masses in the Italian population. The authors of this study concluded that HE4 should be added to clinical and imaging criteria for the discrimination of benign from malignant pelvic masses in women suspected of having epithelial ovarian cancer.(1)

The Clinica Chimica Acta paper is the eighth peer-reviewed publication validating the performance of the combined HE4/CA125 tests in the independently validated ROMA algorithm. Combining these tests enables physicians to identify those patients with high risk of malignancy who should be treated by a gynecologic oncologist. Studies have shown that women who receive surgery from physicians specially trained in the management of ovarian cancer have increased overall survival.(2)

The study of 259 women admitted to the gynecologic oncology unit of the University of Brescia, Italy, evaluated two different HE4 test methods - the manual Fujirebio Diagnostics EIA kit and the automated Abbott ARCHITECT CEIA kit - and compared the ability of HE4, CA125 and ROMA in distinguishing cancer from benign lesions in women having surgery for a pelvic mass. In the study, the ROMA algorithm was able to identify 95.8% of malignant pelvic masses and correctly identified 75% of the benign pelvic masses. "In our experience, the sensitivity of ROMA at a fixed specificity of 75% was even better than declared in the original report by Moore, et al.(3), and in general agreement with the results recently found both in Italy and in other countries," according to the authors.(1) The study further showed that the two different methods of measuring HE4, provided equivalent clinical performance.

"This study confirms that HE4 testing is a reliable and robust method that in combination with CA125 improves current laboratory diagnosis of ovarian cancer," stated Professor Sergio Pecorelli, senior author on the study and Chairman of the Department of Obstetrics and Gynecology and Director of Gynecologic Oncology and Pelvic Surgery at the University of Brescia.

"We at Fujirebio Diagnostics are pleased to see yet another study validating the utility of HE4 and ROMA in women being treated for a pelvic mass," said Grady Barnes, PhD, Chief Scientific Officer and Vice President of Research and Development at Fujirebio Diagnostics. "The increased sensitivity of HE4 at a higher specificity, as demonstrated in this study, provides the gynecologist with an accurate tool for differentiating malignant from benign pelvic masses and improves triage of patients to appropriate referral centers."

About HE4 and ROMA

The ROMA algorithm uses the results from simple blood tests, CA125 and HE4, to identify patients at a high or low risk of having ovarian cancer. The HE4 assay is cleared by the United States Food and Drug Administration (FDA) as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Additionally, the HE4 assay is cleared by the Chinese State Food and Drug Administration (SFDA) and carries the CE mark in the European Union as a tool for estimating the risk of ovarian cancer in patients presenting with a pelvic mass, as well as an aid in monitoring for recurrence of disease.

About Ovarian Cancer

Each year, approximately 140,000 women around the world are diagnosed with ovarian cancer. The seventh-leading cause of cancer death in women, ovarian cancer accounts for 4% of all female cancers and is the eighth most common cancer among women.(4) Women who are postmenopausal are at the greatest risk for ovarian cancer.(5)

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker test, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. Fujirebio Diagnostics is one of the group companies of Miraca Holdings Inc. in Japan, set up in July 2005 to combine Fujirebio Inc., the leading in-vitro diagnostics company, and SRL, Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network, which enables physicians and patients to access its diagnostic products. For more information about Fujirebio Diagnostics, please call +1-610-240-3800 or visit http://www.fdi.com.

(1) Ruggeri G, Bandiera E, Zanotti L, et al. HE4 and epithelial ovarian cancer: Comparison and clinical evaluation of two immunoassays and a combination algorithm. Clin Chim Acta. 2011;412(15-16):1447-53. Epub 2011 Apr 30.

(2) Paulsen T, Kjaerheim K, Kaern J, Tretli S, Trope C. Improved short-term survival for advanced ovarian, tubal, and peritoneal cancer patients operated at teaching hospitals. Int J Gynecol Cancer. 2006;16(Suppl 1):11-7.

(3) Moore RG, McMeekin DS, Brown AK, et al. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009;112(1):40-6.

(4) Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61(2):69-90.

(5) American College of Obstetricians and Gynecologists. ACOG Committee Opinion: number 280, December 2002. The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Obstet Gynecol. 2002;100(6):1413-6.

SOURCE Fujirebio Diagnostics, Inc.