New Publication Validates Use of HE4 in Evaluating Risk of Ovarian Cancer

By Fujirebio Diagnostics Inc., PRNE
Sunday, June 5, 2011

MALVERN, Pennsylvania, June 6, 2011 -

- 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

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

"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

"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

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

(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

(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

(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.

Megan Faulkner of JFK Communications, Inc., +1-609-514-5117, Mobile, +1-908-268-5113, mfaulkner at

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