Why are we doing this alone? A collaborative framework for LDT development and validation

Area of Science:

• Clinical diagnostics
• Molecular diagnostics
• Health policy

Background:

• Laboratory-developed tests (LDTs) are crucial for rare infections and vulnerable patients.
• Current US regulatory and reimbursement systems hinder diagnostic test innovation and implementation.
• Hospital laboratories face resource constraints in developing and validating new tests.

Purpose of the Study:

• To propose a collaborative model for infectious disease molecular diagnostics.
• To maintain analytical rigor while supporting clinical validity with shared evidence.
• To improve access to and efficiency of diagnostic testing.

Main Methods:

• Establish a voluntary national repository for standardized analytical and clinical validation data.
• Aggregate data for technically identical assays to enable cumulative validation.
• Utilize shared data for in-house LDT implementation and expanded FDA-cleared test applications.

Main Results:

• Shared data sets can reduce redundant validation efforts in hospital laboratories.
• The model facilitates broader access to testing near the point of care.
• Manufacturers can leverage data for expanded intended use applications of existing tests.

Conclusions:

• The proposed framework strengthens hospital laboratory capacity and accelerates test implementation.
• This collaborative approach improves patient outcomes and healthcare system efficiency.
• Shared validation data is key to overcoming regulatory and resource barriers for LDTs.