Lexicon for blood-based early detection and screening: BLOODPAC consensus document.

Area of Science:

• Oncology
• Biomarker Discovery
• Medical Diagnostics

Background:

• Cancer remains a leading cause of death in the US, with 2.0 million new cases and 600,000 deaths estimated in 2024.
• Early cancer detection significantly improves treatment success rates.
• Current cancer screening is limited to a few cancer types, leaving many unscreened.

Purpose of the Study:

• To address the need for standardized terminology in the rapidly evolving field of non-invasive cancer detection.
• To accelerate the development, access, and adoption of single- and multi-cancer detection (SCD and MCD) tests.
• To establish a foundational lexicon for the Early Detection & Screening (ED&S) Working Group of the Blood Profiling Atlas in Cancer (BLOODPAC) Consortium.

Main Methods:

• Compilation of a lexicon of 14 primary terms relevant to SCD and MCD tests.
• Selection criteria included perceived importance, frequency of use, lack of clarity, and unique challenges.
• The lexicon was submitted to the Food and Drug Administration (FDA) for feedback and incorporated revisions.

Main Results:

• The ED&S Working Group has compiled and presents the first installment of a standardized lexicon for cancer detection tests.
• This lexicon aims to harmonize terminology among diverse stakeholders in the early cancer detection field.
• The presented terms will form part of an online dictionary to support future BLOODPAC initiatives.

Conclusions:

• Standardized definitions are crucial for clear communication and progress in the field of early cancer detection.
• The developed lexicon provides a foundation for consistent terminology in the development and regulation of novel cancer screening tests.
• This initiative by the BLOODPAC's ED&S Working Group is a key step towards advancing the discipline of early cancer detection.