Reporting

Moon allows you to easily draft a case report including the variants of your choice. The Reporting module can be accessed via the Report tab on top of the screen.

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Adding variants to the report

Any shortlisted variant (SNVs, Carrier SNV, SV, Manually filtered) can be added to the report by clicking the report icon on the right of the variant summary display.

The icon is highlighted in blue for variants that have been added to the report. Clicking this icon again allows you to remove variants from the report.

Reviewing and finalising the report

To review and finalise the report, click the Report tab on top of the screen. On the Report screen, you will find:

• The possibility to add a Report conclusion as text, in which you can summarise the findings presented in the report.

• An overview of all applied Filter sets for that analysis, including the gene panels that are part of each filter set and the corresponding panel version. Filter sets are automatically added to the Report of an analysis when applying them in the Filter view. They can be manually removed from the report, although this action will be traceable in the Sample logs.

• An overview table of the variants included in the report, including their genomic position, genotype, gene name and annotated disorder. The order in which variants are displayed in the report can be changed by simply dragging and dropping the variants in the order of your choice in the overview table.

• For each variant reported from within the SNV and Carrier tabs in the shortlist, Moon automatically generates a full text note, summarising the main annotations for the variant. This automatically provided note can be edited, removed, replaced or used as such. The language of the automatically generated report can be indicated on the Patient info screen.

• A variant classification can be added for each included variant (Pathogenic - Likely pathogenic - VUS - Likely benign - Benign). For GRCh37 variants, Moon allows you to quickly check a variant's ACMG classification using wInterVar. Simply click the link next to the classification menu to open the wInterVar classification of that specific variant in a separate tab. For variants that are included in the lab’s KB, the classification is automatically assigned.

• PubMed references can be added by simply pasting the relevant PubMed URL or PubMed ID and then clicking 'Add publication' on the right.

When ready, one or more digital signatures/authorisations can be added to approve the report.

Adding a signature or authorization

At the bottom of the Report screen, the user will see a button labeled as Sign report or Authorize report depending on his/her role within the Moon lab account. The Administrator of the lab account has the ability to define which users have the ability to Sign or Authorize reports. This can be defined on the accounts page.

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When clicking the Sign Report/ Authorize report button, the digital signature is added to the report for that specific analysis. The software indicates who signed the report and when. The digital approval will also be added to the PDF report for that specific analysis. Digital signatures/authorisations are also tracked in the Sample logs.

Multiple digital approvals

Moon allows reports to be digitally approved by multiple lab members, with no restrictions on the number of approvals that can be added. This allows for maximum flexibility.

For a two person approval, an example of a possible flow is indicated below:

• When finalised, the report is digitally Signed by lab members indicated by the Administrator to have the capability of Signing reports.

• Below the digital signature, the drop-down menu at the right, allows to assign the sample to another member of the Lab account for the second and final approval. This person should be a lab member with the capability to Authorize reports.

• Upon assigning the sample to another lab member, that lab member will see a notification on the Sample Overview screen, that new samples have been assigned. These can easily be viewed by using the My Samples filter.

• When opening the report, that includes the first digital signature, the second lab member can now Authorize the report by clicking the Authorize report button and as such add a second digital approval to the analysis report.

• The case can now be closed.

Generating a PDF report

By clicking the View PDF button on top right of the Report screen, a PDF report is generated. This PDF automatically includes:

• A front page with the sample name and date on which the report was generated.

• The phenotype of the patient including the patient’s gender, age of onset of symptoms, the referral note and the HPO terms used to perform the Moon analysis, as they were entered on the Patient Information screen.

• Methods & Results indicating the number of analysed variants by Moon, the Report conclusion (if added) and the overview table of the discussed variants with their assigned clinical classification.

• For each of the reported variants, several annotations are displayed. Additionally, the variant discussion and references to literature are displayed.

• Several variant annotations in the report are hyperlinked, so you can easily click out to further information (eg. genomic location, annotated disease, individual transcripts etc.).

• Digital signatures

• An appendix listing the applied Filter sets and the list of all genes included in the panels part of these filter sets.

The annotations and automatically generated report note can also be retrieved via the Moon API to integrate with an existing reporting functionality.