Fujirebio Diagnostics Announces FDA Clearance of Lumipulse® G CA19-9-N Assay

Tuesday, December 17, 2019 Drug News
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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® G1200 CA19-9-N assay for testing on its LUMIPULSE® G1200 immunoassay platform.

MALVERN, Pa., Dec. 17, 2019 /PRNewswire-PRWeb/ -- 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® G1200 CA19-9-N assay for testing on its LUMIPULSE® G1200 immunoassay platform.

The assay is to be used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA 19-9 at some point in their disease.

The LUMIPULSE® G1200 CA19-9-N immunoassay

  • Has an extended measuring range to 80,000 U/ml with auto dilution capability
  • Minimizes waste through the single dose cartridge system
  • Offers excellent precision with a CV of =5.7 %
"The combination of the unique single cartridge reagent system and extended measuring range up to 80,000 U/mL will allow laboratories, even those with lower volumes, to economically run CA 19-9 in-house, eliminate send-out costs and reduce turnaround time," 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 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 (IVD) 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 http://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.

 

SOURCE Fujirebio



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