Considerations for standardizing predictive molecular pathology for cancer prognosis

Area of Science:

• Molecular pathology
• Digital pathology
• Laboratory automation

Background:

• Molecular tests are increasingly central to pathology, driven by rapid advancements in molecular biology.
• Traditional molecular techniques are being superseded by newer, more powerful methods.

Purpose of the Study:

• To review technical and regulatory challenges in standardizing molecular pathology tests.
• To provide insights into future technological trends in molecular pathology.

Main Methods:

• Discussion of current molecular techniques (FISH, sequencing, PCR) and their evolution.
• Exploration of automation in pre-analytical steps and integrated laboratory information systems.
• Overview of digitalization in in situ hybridization, immunohistochemistry, and histology.

Main Results:

• Massive parallel sequencing is becoming the current standard, replacing older techniques.
• Automation and integrated workflows are streamlining molecular testing processes.
• Digitalization is transforming traditional methods like microscopy and in situ hybridization.

Conclusions:

• Molecular pathology is a rapidly evolving field with significant technological shifts.
• Standardization and integration are key challenges and future directions for molecular pathology.
• Digitalization and advanced sequencing technologies are reshaping diagnostic pathology.