fujirebio diagnostics, inc. is a premier diagnostics company and the industry leader in 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.
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Company Address:
30 Two Bridges Road - Suite 250,FAIRFIELD,NJ,USA
ZIP Code: Postal Code:
7004
Telephone Number:
16042572700 (+1-160-425-72700)
Fax Number:
19735910756 (+1-197-359-10756)
Website:
fujirebioamerica. com, ground0. com, prietive. com, prietive. net, prietivegroup. net
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USA SIC Code(Standard Industrial Classification Code):
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FDA Approves Fujirebio’s CSF Test for AD—Quest . . . - ALZFORUM Fujirebio’s CSF Aβ test was approved through the FDA’s De Novo pre-market review pathway, which is used for devices or assays with little risk to the patient The test, an immunoassay run on the fully automated Lumipulse platform, is intended for use in people 55 or older with cognitive impairment
Trouble with Fujirebio’s FDA-Cleared Blood Test? Or a Lousy Lot? Fujirebio’s Lumipulse p-tau217 Aβ42 is being tested in different cohorts Among amyloid-negative people seen at the Mayo Clinic, 40 percent tested positive Scientists ask if the test will perform well in real-world cohorts
A First: FDA Approves Alzheimer’s Blood Test | ALZFORUM Patients and doctors prefer blood tests for routine clinical use The FDA ruled that Fujirebio’s new plasma assay is “substantially equivalent” to the company’s previously cleared CSF test In multicenter testing on 499 cognitively impaired people, the blood test had a positive predictive value of 92 percent, and a negative predictive value of 97 percent, for detecting plaques found by
In Head-to-Head Testing, P-Tau217 Tau217 Comes Out on Top . . . - ALZFORUM The ALZpath and Fujirebio p-tau217 assays came in a close second, with accuracies of 0 84 and 0 83, respectively, followed by Janssen’s 0 82 All did much better at detecting brain amyloid than did tests of p-tau181, GFAP, or NfL (table below)
Looking Good: Immunoassays for Blood Markers | ALZFORUM Last September, Fujirebio filed for approval of the Lumipulse p-tau217 Aβ42 test with the U S Food and Drug Administration, while LabCorp, a global diagnostics company, began selling this test in the U S on April 2
Blood Amyloid Test May Help Diagnose Alzheimer’s, but . . . - ALZFORUM Fujirebio’s Lumipulse Aβ42 40 test got FDA approval in May (May 2022 news) Earlier this month, FDA similarly greenlighted Roche’s Elecsys p-tau181 Aβ42 assay (press release) Both immunoassays are intended for use in people 55 or older with cognitive impairment
The Amyloid, Tau, and Neurodegeneration (A T N) Classification Applied . . . Grøntvedt GR, Lauridsen C, Berge G, White LR, Salvesen Ø, Bråthen G, Sando SB The Amyloid, Tau, and Neurodegeneration (A T N) Classification Applied to a Clinical Research Cohort with Long-Term Follow-Up J Alzheimers Dis 2020;74 (3):829-837 PubMed AlzBiomarker Database Meta-Analysis AD vs CTRL : Aβ42 (CSF) CTRL vs AD : Aβ42 (CSF) AD vs CTRL : tau-p181 (CSF) CTRL vs AD : tau-p181 (CSF
ALZFORUM | NETWORKING FOR A CURE Professional Information Manager New Product DevelopmentFujirebio Europe NV http: www fujirebio-europe com
Comparison of Diagnostic Performances Between Cerebrospinal Fluid . . . Jung NY, Kim ES, Kim HS, Jeon S, Lee MJ, Pak K, Lee JH, Lee YM, Lee K, Shin JH, Ko JK, Lee JM, Yoon JA, Hwang C, Choi KU, Lee EC, Seong JK, Huh GY, Kim DS, Kim EJ Comparison of Diagnostic Performances Between Cerebrospinal Fluid Biomarkers and Amyloid PET in a Clinical Setting J Alzheimers Dis 2020;74 (2):473-490 PubMed
Cerebrospinal Fluid and Plasma Biomarkers in Neurodegenerative Diseases . . . Seino Y, Nakamura T, Kawarabayashi T, Hirohata M, Narita S, Wakasaya Y, Kaito K, Ueda T, Harigaya Y, Shoji M Cerebrospinal Fluid and Plasma Biomarkers in Neurodegenerative Diseases J Alzheimers Dis 2019;68 (1):395-404 PubMed AlzBiomarker Database Meta-Analysis AD vs CTRL : Aβ40 (CSF) AD vs CTRL : Aβ40 (Plasma and Serum) CTRL vs AD : Aβ40 (CSF) CTRL vs AD : Aβ40 (Plasma and Serum) MSA