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Roche

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…

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Roche

Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Shots: 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 Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea

Shots: 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 Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: 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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Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: 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 Forges ~$1.7B Deal with Novartis to Advance Therapeutics for Alzheimer’s Disease

Shots: 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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Inside Anavex’s Alzheimer’s Strategy: Dr. Christopher Missling on Blarcamesine, SIGMAR1, and Precision Medicine 

Shots:   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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