Table 3.

The NGS report: minimal content requirements

Laboratory/patient/sample identifier	•Patient’s name, date of birth, sex •ID number •Date specimen collected •Date specimen received •Date results reported •Ordering physician •Laboratory name
Specimen used for NGS testing	•Specimen type (FFPE, frozen tissue, liquid biopsy) •in case of tumor tissue: oTissue information with diagnosis oTumor cell content
Results	•Results with test name •Range •Use standard gene nomenclature •For variants also VAF (variant allele frequency)
Methodology/procedure	•Target description •Specimen-enrichment method •Limit of detection •Additional assay limitations
Procedure	•Type of procedure (e.g. NGS) •Defined target (e.g. name of target tested such as gene, locus, or genetic defect; use HUGO-approved gene nomenclature, HGVS nomenclature) •Analytic interpretative comment •Clinical interpretative comment •Pathologist/designee signature •LDT reporting language •ASR language
Comments	•Significance of the result in general or in relation to this patient •Correlate with prior test results •Recommend additional measures (further testing, genetic counseling) •Condition of specimen that may limit adequacy of testing •Pertinent assay performance characteristics or interfering substances •Cite peer-reviewed medical literature or reliable web sites on the assay and its clinical utility •Document intradepartmental consultation •Document to whom preliminary results, verbal results, or critical values were reported and when •Incorporate information specifically requested on requisition •Answer specific questions posed by the requesting clinician •Reason specimen rejected or not processed to completion •If the report is an amended or addendum report, describe the changes or updates •Describe discrepancies between preliminary and final reports •Name of testing laboratory, if transmitting or summarizing a referral laboratory’s results

ASR, analyte specific reagents; FFPE, formalin-fixed, paraffin-embedded; HGVS, Human Genome Variation Society; HUGO, Human Genome Organisation; LDT, laboratory-developed test; NGS, next-generation sequencing.