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mRNA Gene Biomarker Test

PharmaDeviceNews mRNA Gene Biomarker Test

Representative image: A blood-based mRNA biomarker test could mark a turning point for objective psychiatric diagnostics as Laguna Diagnostics advances its FDA breakthrough-designated tool to help clinicians differentiate schizophrenia from bipolar I disorder.

Medical Devices & Diagnostics

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

by Pallavi Madhiraju
April 29, 2026
0 Comments

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

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POPULAR NEWS

Representative image of a clinician reviewing skeletal imaging, illustrating Mirum Pharmaceuticals and Incyte’s zilurgisertib Phase 2 progress in fibrodysplasia ossificans progressiva and the rare disease treatment questions facing regulators.

Pharma & Biotech

Why Mirum Pharmaceuticals and Incyte’s zilurgisertib data could reset expectations in FOP treatment

June 15, 2026

Niagen Bioscience’s NB4168 has secured U.S. FDA Rare Pediatric Disease and European orphan designations as the company advances the experimental ataxia telangiectasia therapy toward human trials. Representative image.

Pharma & Biotech

Niagen wins twin rare-disease designations, but can NB4168 turn nicotinamide riboside evidence into a medicine?

July 14, 2026

Representative image of biopharma laboratory research. Gilead Sciences and Merck’s latest Phase 3 updates highlight the promise of once-weekly HIV treatment with islatravir and lenacapavir, while raising fresh questions over Trodelvy’s lung cancer expansion strategy.

Pharma & Biotech

Gilead and Merck pipeline update reveals promise in HIV and pressure in oncology

June 9, 2026

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clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

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