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.
Keywords to Search:
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
Email:
USA SIC Code(Standard Industrial Classification Code):
copy and paste this google map to your website or blog!
Press copy button and paste into your blog or website.
(Please switch to 'HTML' mode when posting into your blog. Examples: WordPress Example, Blogger Example)
Input Form:Deal with this potential dealer,buyer,seller,supplier,manufacturer,exporter,importer
(Any information to deal,buy, sell, quote for products or service)
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
Two New p-Tau217 Blood Tests Join a Crowded Field The blood-based p-tau marker field is getting pretty busy In addition to existing tests by Fujirebio, Lilly, Janssen, and Meso Scale Discovery, C2N debuted a new CLIA-approved mass spectrometry-based test last August, while ALZPath Inc still plans to offer its immunoassay for clinical use in 2023
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
FDA Clears Roche’s CSF Aβ42 tTau Assay - ALZFORUM In May 2022, the FDA approved Fujirebio’s fully automated CSF Aβ42 40 test to run on that company's benchtop Lumipulse analyzers, which are also widely distributed (May 2022 news) Both Quest Diagnostics, Seacaucus, New Jersey, and C2N Diagnostics, St Louis, run assays for plasma Aβ42
Some Alzheimer’s Blood Tests Are Racing Toward IVD Certification Fujirebio last September requested approval from the FDA for its plasma p-tau217 Aβ1-42 test At CTAD, Fujirebio’s ManuVandijck said that following the FDA submission, the company also plans to seek IVD approval from the Competent Authorities for Medical Devices in the EU, and the Pharmaceutical and Medical Devices Agency in Japan
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
NULISA Proteomics Platform Takes Off for Diagnostics, Discovery For example, in the February 2025 Alzheimer’s Dementia, scientists led by Albert Puig-Pijoan and Marc Suárez-Calvet at the Barcelonaβeta Brain Research Center, Spain, reported on a study that pitted NULISA p-tau217, p-tau181, and Aβ42 40 tests against assays from Fujirebio, Roche, Meso Scale Discovery, and ALZpath