Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G whole PTH Assay

Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G whole PTH Assay
A 3rd Generation Assay to Accurately Measure Biologically Active Parathyroid Hormone Levels Resulting From Disorders of Calcium Metabolism

MALVERN, PA — 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 hormone 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 fragments(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 Lumipulse® 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.

Source: Fujirebio Diagnostics, 205 Great Valley Pkwy, Malvern PA 19355
(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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