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Home»Posts tagged with»blood-based biomarkers

Why Europe’s Alzheimer’s testing pathway could shift after Fujirebio’s latest CE marking

By Pallavi Madhiraju on May 11, 2026   Medical Devices & Diagnostics  

Why Europe’s Alzheimer’s testing pathway could shift after Fujirebio’s latest CE marking

Alzheimer’s testing needs scale, not just science. Fujirebio’s CE-marked pTau 217 assay pushes blood biomarkers closer to routine care.

Why the FDA breakthrough pathway matters for Laguna Diagnostics’ psychiatric test

By Pallavi Madhiraju on April 29, 2026   Medical Devices & Diagnostics  

Why the FDA breakthrough pathway matters for Laguna Diagnostics’ psychiatric test

Psychiatry needs objective diagnostics. Laguna Diagnostics now faces the harder test: proving mRNA biomarkers can scale in real care.

What Spear Bio’s new pTau 217 assay reveals about where Alzheimer’s biomarker detection is heading

By Pallavi Madhiraju on March 24, 2026   Medical Devices & Diagnostics  

What Spear Bio’s new pTau 217 assay reveals about where Alzheimer’s biomarker detection is heading

Spear Bio debuts BD-pTau 217, alpha-synuclein and pS129-a-syn assays at AD/PD 2026. What the claims mean for Alzheimer’s and Parkinson’s research. Read the analysis.

C2N Diagnostics advances PrecivityTauDx programme as tangle biomarker gains Phase 3 evidence

By Pallavi Madhiraju on March 22, 2026   Medical Devices & Diagnostics  

C2N Diagnostics advances PrecivityTauDx programme as tangle biomarker gains Phase 3 evidence

C2N’s eMTBR-tau243 plasma assay shows independent prognostic value in Phase 3 Evoke data. What this means for Alzheimer’s patient selection. Read the analysis.

Lucent Diagnostics expands cognitive biomarker reach through Life Line Screening

By Pallavi Madhiraju on March 3, 2026   Medical Devices & Diagnostics  

Lucent Diagnostics expands cognitive biomarker reach through Life Line Screening

Lucent Diagnostics partners with Life Line Screening to expand Alzheimer’s blood testing nationwide. Discover what this means for early detection.

Can EpiSwitch PSE become more than a diagnostic tool in prostate disease management?

By Pallavi Madhiraju on January 25, 2026   Medical Devices & Diagnostics  

Can EpiSwitch PSE become more than a diagnostic tool in prostate disease management?

Doctors Studio’s ozone pilot shows promising 30-day shifts in prostate biomarkers tracked via EpiSwitch PSE. Could this reshape trial design? Find out.

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