A consultation and work-up diagnosis protocol for a multicancer early detection test: a case series study

Area of Science:

• Oncology
• Genomics
• Medical Diagnostics

Background:

• Multicancer early detection (MCED) tests offer potential for improved cancer diagnosis and public health.
• Positive MCED results necessitate confirmation via established cancer diagnostic imaging.
• Challenges exist in interpreting and managing results from novel early detection methods.

Purpose of the Study:

• To develop a standardized consultation and work-up protocol for definitive diagnostic results following MCED testing.
• To create a protocol, named SPOT-MAS, to aid general practitioners in managing MCED test outcomes.
• To facilitate the clinical integration of MCED tests by standardizing post-testing procedures.

Main Methods:

• Development of the SPOT-MAS protocol based on circulating tumor DNA (ctDNA) analysis.
• Alignment of the protocol with professional guidelines and advisory board consensus.
• Demonstration of clinical effectiveness through a series of identified cancer cases.

Main Results:

• The SPOT-MAS protocol standardizes information for general practitioners managing MCED results.
• The protocol aids in accessing, interpreting, and managing results from ctDNA analysis.
• Clinical effectiveness was demonstrated in identifying cancer cases post-MCED testing.

Conclusions:

• The SPOT-MAS protocol empowers healthcare professionals to confidently interpret ctDNA test results.
• The protocol supports the interpretation of results for five common cancer types.
• This work facilitates the clinical integration of MCED tests into standard healthcare practice.