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Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G whole PTH Assay
Date:10/29/2019

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 whole PTH Assay for testing on its LUMIPULSE® G1200 immunoassay platform.

Parathyroid hormone (PTH) is a horomone secreted by the parathyroid glands; which are four small glands located behind the thyroid gland. The hormone regulates metabolism of Calcium and Phosphoric Acid in the body. The measurement of whole Parathyroid Hormone (wPTH or PTH (1-84)) using the Lumipulse® G whole PTH assay can be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders.

The Lumipulse® G whole PTH assay has a significant benefit over prior generation intact PTH assays currently used in most laboratories.The measurement of biologically active PTH (1-84) helps to understand parathyroid function without potential misclassification of the patients. There is no detectable cross reactivity to 7-84 and other PTH fragments observed with intact PTH (iPTH) assays; since whole PTH measures only the biologically active PTH and is 100% specific to whole PTH. Intact PTH can overestimate PTH indicated bone/mineral abnormalities because iPTH assays also detect various PTH fragements(1).

For Chronic Kidney Disease (CKD) patients not yet on dialysis (stage 3-5), The Clinical Practice Guideline CKD-MBD, Final Version (1/3/2015) recommends the measurement and monitoring of several tests including PTH as part of patient management. A falsely high PTH measurement due to a second generation iPTH test may result in falsely identifying a patient for dialysis.(2)

The Lumipule® G whole PTH is also traceable to in-house calibrators that have been assigned to the World Health Organization’s (NIBSC 95/646) standard; while iPTH assays are not standardized and their values can vary by manufacturer.

The Lumipulse® G whole PTH Assay on the Lumipulse® G1200 analyzer offers a fully automated assay with a reaction time of just 30 minutes; using a single test cartridge design for reagent stability, efficiency, and testing flexibility. The assay has demonstrated excellent precision with a CV of =4.0%.

“The Lumipulse® G whole PTH Assay is an innovative next-generation assay to help diagnose Calcium metabolism disorders, and to help monitor and adjust treatment of CKD patients.” says Matthew Bell, Vice President Sales and Marketing at Fujirebio, US.

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 https://www.fujirebio.com/en.

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.

(1) Kazama, J, Intact PTH assay overestimates true 1-84 PTH levels after maxacalcitol therapy in dialysis patients with secondary hyperparathyroidism, Nephrology Dialysis Transplantation (2004) 19:892-897
(2) Priolo, G. Comparison between whole and intact Parathyroid Hormone assays, FRE-117, May 2017

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