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Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream
The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…
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C2N Diagnostics has entered into an agreement with BeauBrain Healthcare to offer PrecivityAD2 blood test for use in pts (≥50yrs.) with signs or symptoms of mild cognitive impairment or dementia in South Korea
Study in The JAMA showed PrecivityAD2 improved diagnostic accuracy of Alzheimer’s disease vs SoC, while research in npj Dementia showed that the test demonstrated 91%…
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Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…
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The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease
Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring
The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
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SciNeuro has entered into a global licensing & collaboration deal with Novartis to advance its amyloid beta-targeted antibody program for Alzheimer’s disease
The program has identified de novo antibody candidates using SciNeuro’s blood–brain barrier shuttle tech, with Novartis leading global development & commercialization after collaboration on early development
As per the deal, SciNeuro will…
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Neurodegenerative care is at a pivotal inflection point, shifting from symptomatic relief to strategies that restore cellular resilience. Blarcamesine (ANAVEX 2-73) advances this upstream approach by activating SIGMAR1 to rebalance autophagy, targeting a core driver of neurodegeneration
Phase IIb/III findings demonstrated a statistically significant slowing of cognitive decline, with the most pronounced benefit seen in patients carrying the…
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ADEL has entered into an exclusive worldwide license agreement with Sanofi for the development & commercialization of ADEL-Y01 & related backup compounds
As per the deal, ADEL will receive a non-refundable payment of $80M upfront plus development & commercial milestones, representing the total deal value of ~$1.04B, tiered royalties on net sales ranging up…
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The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD)
NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
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The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment
Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…
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Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology
Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…

