Fujirebio Diagnostics, Inc. Receives FDA 510 (k) Clearance for First Biomarker to Monitor Lung Cancer

MALVERN, Pennsylvania, May 31, 2011 /PRNewswire/ --

- FDA Decision Clears Way for CYFRA 21-1(TM) to Monitor Disease Progression in Patients with Lung Cancer

Fujirebio Diagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance to the CYFRA 21-1(TM) EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients. This is the first biomarker assay kit to be cleared by FDA for use in the management of patients with lung cancer.

"The clearance of the CYFRA 21-1 assay kit adds to Fujirebio's growing portfolio of tumor marker assays for ovarian cancer, pancreatic cancer, breast cancer, and other malignancies," commented Monte Wiltse, Vice President of Sales and Marketing at Fujirebio Diagnostics. "Achieving FDA clearance of the CYFRA 21-1 assay kit for lung cancer is the first step in what we anticipate will be a strong pipeline of innovations that help physicians in the management of lung cancer."

The CYFRA 21-1 assay kit is indicated for the quantitative determination of soluble cytokeratin 19 fragments in human serum. It is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with lung cancer. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer. Data submitted to FDA showed that changes in CYFRA 21-1 values correlated with changes in disease status in 76% of the studied patient population.

According to the Surveillance Epidemiology and End Results (SEER) database of the National Cancer Institute (NCI), an estimated 222,520 new cases of lung cancer were diagnosed in the U.S. in 2010, and roughly 157,300 Americans died of the disease.(1)

"FDA clearance of CYFRA 21-1 allows laboratories in the US the opportunity to provide a valuable diagnostic tool to oncologists in the management of lung cancer," said David Grenache, PhD, a Medical Director at ARUP Laboratories in Salt Lake City, UT. "ARUP Laboratories is pleased to offer the first ever FDA cleared biomarker for lung cancer to physicians in the US."

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. 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 610-240-3800 or visit http://www.fdi.com

(1) Altekruse SF, Kosary CL, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975-2007. http://seer.cancer.gov/csr/1975_2007/, based on November 2009 SEER data submission. Bethesda, MD: National Cancer Institute. Posted to the SEER Web site, 2010. Accessed September 27, 2010.