Fujirebio announces coverage by Cigna for ROMA® (Risk of Ovarian Malignancy Algorithm)

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An additional 15 million covered lives now have access to ROMA® (Risk of Ovarian Malignancy Algorithm), a pre-surgical test to help assess women with an ovarian mass.

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Early and appropriate care by a gynecologic oncologist can help increase survival rates in women with ovarian cancer and decrease the number of complications.

Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings, Inc. and an industry leader in cancer biomarker assays, announced today that Cigna has added ROMA® (Risk of Ovarian Malignancy Algorithm) to its national preferred coverage list. Cigna Corporation is a global health service company dedicated to improving the health, well-being, and peace of mind of the customers they serve. This decision to add ROMA further demonstrates Cigna’s focus to help reduce patient health costs and achieve optimal health outcomes.

The ACOG (American College of Obstetricians and Gynecologists) recommendations include ROMA as one of several risk assessment algorithms when referring patients with an adnexal mass. ROMA is a qualitative test that combines the quantitative results of HE4, CA 125 and menopausal status into a numerical score. It can be performed in any laboratory that also provides CA 125 testing services. Each ROMA result automatically includes the individual results of CA 125, HE4 and the ROMA score. ROMA is intended to aid in assessing whether premenopausal or postmenopausal women who present with an ovarian adnexal mass are at high or low likelihood of finding malignancy on surgery. CA 125 is within normal limits in 50% of women with stage 1 disease, is often falsely positive in benign conditions like endometriosis, and is not approved as a risk assessment tool for ovarian masses. ROMA helps to address some of these shortcomings.

“With over 21,000 women in the U.S. diagnosed per year with ovarian cancer, we are pleased to see the increase in the number of women who will now have access to ROMA,” says Monte Wiltse, CEO/President at Fujirebio Diagnostics, Inc. “Early and appropriate care by a gynecologic oncologist can help increase survival rates in women with ovarian cancer and decrease the number of complications.”

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced CA 125, the first FDA approved ovarian cancer biomarker, over 25 years ago and introduced HE4 and ROMA for ovarian cancer management in 2008 and 2011, respectively. 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. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at http://www.he4test.com.

About Fujirebio

Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is a wholly-owned subsidiary of Miraca Holdings Inc. (listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1,200 people in Asia, Europe and America.

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Lauren Lehman
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