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COMMUNITY NEWS 2024-05-10 Community News For decades, the U.S. Food and Drug Administration has taken a light touch to regulating diagnostic tests that use body fluids or tissues. Such assays, very much including cerebrospinal fluid and blood tests for Alzheimer’s disease, were ab
GRANT Friday, May 10, 2024- 3:30pm National Institutes of Health Applicants may request up to $375,000 in direct costs, excluding consortium F&A, for the entire project period of up to 3 years. Multiple due dates; see announcement. https://grants.nih.gov/gr
GRANT Friday, May 10, 2024- 3:30pm National Institutes of Health Applicants may request up to $375,000 in direct costs, excluding consortium F&A for the entire project period of up to 3 years. Multiple due dates; see announcement. https://grants.nih.gov/gra
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
PAPER
PAPER Vigers M, Lobo S, Najafi S, Dubose A, Tsay K, Ganguly P, Longhini AP, Jin Y, Buratto SK, Kosik KS, Shell MS, Shea J-E, Han S
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,
RESEARCH NEWS 2024-05-10 Research News For 30 years, APOE4 has ranked as the strongest genetic risk factor for Alzheimer’s disease, with two copies boosting the odds up to 15-fold. Now, scientists make the case that people with two APOE4 alleles are not merely at risk, but are de
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
PAPER Burnham SC, Cox T, Benzinger T, et al
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