11227 RESULTS
COMMENT APOE4 is the strongest risk factor for Alzheimer’s disease. APOE4 homozygosity was recently identified as a distinct, highly penetrant form of AD. However, a small percentage of APOE4 homozygotes live cognitively normal lives into their 80s and beyond (Fo
COMMENT In this very interesting paper Bretou et al. described the toxic effect produced by the genetic and pharmacologic inhibition of the γ-secretase complex. The authors described that these treatments increased the levels of APP-CTF inducing a dysfunction of
COMMENT This study is really exciting because it used longitudinal neuroimaging to understand factors that lead to tau accumulation in the brain and to later cognitive decline. We already knew that structural integrity of the locus coeruleus, a brainstem region o
COMMENT Laboratory-developed test (LDTS) in the current framework are an important tool to accelerate innovation, in particular in rapidly evolving diagnostic markets such as AD. Understanding risks/benefits, the target, performance in racial populations, and mul
COMMENT have already started direct-to-consumer selling of these tests, and in an earlier comment I and others
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
