Dxplora diagnostics development and manufacturing coordination
PCR Assay Development Support for CLIA Laboratories
Configurable PCR assay formats, evaluation lots, and a coordinated path to repeat manufacturing for laboratories developing or modifying molecular testing workflows.
Dxplora coordinates
- Assay and format scoping
- Development partner coordination
- Evaluation and pilot quantity planning
- Repeat manufacturing planning
The laboratory owns
- Intended use
- Performance specifications and study design
- Laboratory implementation and quality procedures
- Patient-result reporting and regulatory pathway
Frequently asked questions
Can Dxplora support PCR assay development for a CLIA laboratory?
Dxplora coordinates qualified development and manufacturing partners for configurable PCR assay formats, evaluation quantities, and repeat supply planning.
Does the laboratory retain responsibility for its LDT?
Yes. The laboratory defines intended use, establishes performance specifications, performs its validation, and remains responsible for its regulatory and quality obligations.
Can an existing bench PCR assay be transferred?
Yes. A project can begin with an existing protocol, primer and probe set, representative amplification data, and known performance issues.
Are liquid and lyophilized PCR formats available?
Projects can evaluate liquid or stability-oriented lyophilized formats based on chemistry, instrument, storage, shipping, and workflow requirements.
Can Dxplora coordinate evaluation and pilot quantities?
Yes. The scope can include evaluation materials, pilot quantities, packaging considerations, and planning for repeat manufacturing.
Does Dxplora operate the laboratory's validation process?
No. Dxplora coordinates assay development and manufacturing support. The laboratory owns study design, validation, implementation, and patient-result reporting.