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

By Fujirebio Diagnostics Inc., PRNE
Monday, May 30, 2011

MALVERN, Pennsylvania, May 31, 2011 -

- 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 www.fdi.com

(1) Altekruse SF, Kosary CL, Krapcho M, et al. (eds). SEER Cancer
Statistics Review, 1975-2007. 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.

Megan Faulkner, JFK Communications, +1-609-514-5117, mfaulkner at jfkhealth.com

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