11522 RESULTS
COMMENT An immunoassay, or any biomarker assay, needs to show acceptable, pre-defined performance criteria before it can be used for patient management or treatment selection, whether it is an IVD, LDT, or a research assay. The assay documentation must show resul
COMMENT It is a good development that the FDA takes oversight of laboratory-developed tests that are used for patient decisions. I do not worry that it affects the development of new tests, but rather expect that it will stimulate it. This is because the investme
COMMENT From our perspective at C2N, we do not believe the FDA’s recent final rule will change much of our strategy and approach to commercializing in vitro diagnostic tests. C2N has a Breakthrough Device designation with FDA for its Precivity™ test to identify a
COMMENT Generally, increased oversight and improved Quality Assurance/Quality Control (QA/QC) is a good thing for the field, particularly as we move into routine clinical practice with significant public health implications. Blood screens for AD need to be shown
COMMENT Although no blood tests for Alzheimer’s disease pathology have yet been approved by the FDA, an increasing number of minimally regulated laboratory-developed tests (LDTs) are clinically available. There is very wide variation in the accuracy and validatio
COMMENT The announcement by the FDA of their Final Rule for increased oversight of laboratory developed tests (LDTs) is long overdue but very welcome. Once fully implemented, this should greatly increase the scientific rigor required for certifying LDTs for clini
COMMENT The APOE4 allele constitutes a unique case among common genetic variants of chronic diseases, exerting a major influence on Alzheimer’s disease (AD) risk. AD also associates with three other distinct genetic forms, featuring rare variants of high effect,
COMMENT Is late-onset, “sporadic” Alzheimer’s disease genetic? Is this a trick question? Ever since Strittmatter and Roses published the first evidence of the association between ApoE and Aβ-amyloid in 1993 (Strittmatter et al., 1993), and as long as he lived, Al
COMMENT Perspective on the findings and their implications. Age-related Alzheimer’s disease (AD) is a neurodegenerative disorder with a complex pattern of genetic and environmental factors contributing to its pathogenesis. One gene stands, however, central for ri
COMMENT I think this paper is helpful in putting some biomarker and neuropathology heft behind the growing consensus in the field that E4 homozygosity, in European ancestry individuals at least, is all but deterministic for the development of Alzheimer’s disease
COMMENT studies and comment that: “Findings revealed that almost all APOE4 homozygotes exhibited AD pathology and
COMMENT We commend Fortea and colleagues for their analyses examining biomarker and clinical changes in a large number of cognitively impaired and unimpaired persons from NACC, Alfa plus, A4 trial, OASIS, ADNI, and WRAP. In general, the results from their retrosp
COMMENT of people would be required. —Camille Le Clézio Charbonnier is the co-author of this comment
COMMENT This study by Coulon et al. is a tour de force, identifying and characterising an exciting neuronal function for the AD gene PLCγ2, which encodes a phospholipase enzyme involved in signal transduction. The multilaboratory team established a loss-of-functi
COMMENT It is well known that certain subcortical modulatory nuclei, including the pigmented pontine nucleus locus coeruleus (LC), exhibit very early tau cytoskeletal pathology. According to earlier large-scale and detailed neuropathological studies by Heiko Braa
