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GTR Home > Tests > RPL9 Deletion/duplication analysis

Performance Characteristics



  • Entire test performed in-house

Analytical Validity


Accuracy: >94%, sensitivity: >94%, precision: 100%


Not provided

Assay Limitation(s)


This assay may not detect deletions and duplications if present in <20% of the tested sample. In some cases, breakpoints may be difficult to determine. This assay is unable to detect genomic rearrangements, point mutations in the gene(s) of interest, or copy number changes in genes with corresponding pseudogenes.

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Method used for proficiency testingHelp

FDA Regulatory Clearances of the Test

FDA Category Designation
FDA exercises enforcement discretion

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