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Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G B•R•A•H•M•S PCT Assay

June 12, 2018

Lumipulse® G B·R·A·H·M·S PCT Assay (Photo: Business Wire)

MALVERN, Pa.--(BUSINESS WIRE)--Jun 12, 2018--Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., has received U.S. Food and Drug Administration (FDA) clearance of the company’s Lumipulse ® G B•R•A•H•M•S PCT Assay for testing on its LUMIPULSE ® G1200 immunoassay platform.

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Lumipulse® G B·R·A·H·M·S PCT Assay (Photo: Business Wire)

Procalcitonin (PCT) is a biomarker specific to bacterial infections. PCT offers advantages as an aid to guide antibiotic treatment decisions or to assess the risk of critically ill patients for progression to sepsis or septic shock.

The Lumipulse ® G B•R•A•H•M•S PCT Assay, when run on the LUMIPULSE ® G1200 immunoassay platform, and used in conjunction with other laboratory findings and clinical assessments, can aide in:

Decision-making for patients with suspected or confirmed lower respiratory tract infection Risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis or septic shock The cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU, or obtained in the emergency department or other hospital setting prior to ICU admission, by measuring a change in PCT level over time Decision-making for patients with suspected or confirmed sepsis

The Lumipulse ® G B•R•A•H•M•S PCT Assay offers excellent precision with a CV of ≤4.7%. With a precise assay, clinicians can more accurately determine the change in PCT levels and, therefore, the effectiveness of antibiotics, as well as make more informed antibiotic initiation and discontinuation decisions. By removing analytical variability of test results when monitoring antibiotic therapy, the Lumipulse ® G B•R•A•H•M•S PCT Assay helps conform to new guidelines for antibiotic stewardship as released by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.

“Serial measurement of procalcitonin levels is a significant innovation for antibiotic stewardship, which can lead to reduced hospitalization stays without adversely affecting patient outcomes,” says Matthew Bell, Vice President Sales and Marketing at Fujirebio, US. “The Lumipulse ® G B•R•A•H•M•S PCT Assay is a significant new tool in the fight against sepsis, lowering hospital re-admission rates, and improving the use of antibiotic treatment.”

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 the CA125 test, the first FDA-approved ovarian cancer biomarker 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. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio-us.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 today a member of Miraca Group (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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CONTACT: Brandwidth Solutions

Debra Harrsch, 215-997-8575

dharrsch@bwsmarketing.com

KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES OTHER SCIENCE FDA SCIENCE

SOURCE: Fujirebio Diagnostics, Inc.

Copyright Business Wire 2018.

PUB: 06/12/2018 07:30 AM/DISC: 06/12/2018 07:30 AM

http://www.businesswire.com/news/home/20180612005301/en

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