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    Molecular Diagnostics

    IVDs that detect nucleic acids - DNA or RNA - to diagnose disease.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Molecular diagnostics use PCR, isothermal amplification, sequencing (NGS), or hybridization to detect pathogens (HPV, HIV, respiratory panels), genetic variants (BRCA, KRAS), and oncology biomarkers (MRD, ctDNA).

    What this means in practice

    COVID accelerated decentralized PCR. Oncology MRD (Natera Signatera, Guardant Reveal) is reshaping post-treatment monitoring. Reimbursement via MolDx and PAMA price cuts shape unit economics.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    AMP·1MedTech Europe·1MedTech Dive·1
    1. 1
      AMP
      Verified
      AMPamp.org
    2. 2
      MedTech Europe - Facts & Figures
      Verified
      MedTech Europemedtecheurope.org
    3. 3
      MedTech Dive
      Verified
      MedTech Divemedtechdive.com

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