Warnings and precaution

Franklin by Qiagen is intended for professional use only. Use of the platform requires users to have appropriate training in genetics and variant interpretation, and to follow their organization’s established SOPs and review protocols before relying on Franklin’s computed classifications or recommendations.

Although risk control measures have been integrated into the platform, users should be aware of the following warnings and precautions:

⚠️ Content updates within Franklin’s knowledge base or public databases may result in changes to variant classification or interpretation over time.

⚠️ Computed classifications may vary between analyses due to updates in algorithms, annotation sources, or curated content.

⚠️ Differences in reference genome builds or transcript versions may result in inconsistent variant nomenclature or interpretation.

⚠️ Some variants may be unmappable or inconsistently mapped due to ambiguities in the reference genome or transcript annotation.

⚠️ Variant interpretations should always be cross-verified using cited literature, Franklin’s linked sources, and user-curated evidence.

⚠️ Errors in input files (e.g., malformed VCFs, incorrect metadata) may lead to processing issues or missed variant calls.

⚠️ Manual curation within Franklin should be performed according to internal review policies to minimize risk of bias or misclassification.

⚠️ Franklin’s automated prioritization and classification tools use current best practices, but may not reflect the most recent expert guidelines or organizational SOPs.

⚠️ Automated variant classification results must be reviewed in the context of the patient’s clinical picture, family history, and additional diagnostic findings.

⚠️ Manual variant classification within Franklin, while flexible, is subject to user variability and should follow validated internal protocols.

⚠️CNV and structural variant calls may include false positives; visual inspection and supporting evidence should always be reviewed.

⚠️ Franklin is not intended to provide standalone medical decisions. The platform assists with interpretation but must be used in combination with professional judgment.

⚠️ Franklin cannot prevent intentional misuse or misinterpretation of results outside the device’s intended scope.

⚠️ In rare edge-case scenarios, a combination of errors (e.g., incorrect classification, lack of review, clinical misjudgment) could contribute to patient risk; safeguards depend on correct use by qualified professionals.

⚠️ When multiple transcript options exist for a variant, users must actively select the appropriate transcript. Relying on an incorrect transcript version may lead to misclassification or inappropriate interpretation.

This category includes warnings and precautions associated with data quality, system interactions, genome assembly discrepancies, and risks related to data input or misinterpretation. The following precautions are advised:

⚠️To avoid unexpected delays in analysis or report delivery, users should plan work accordingly when notified of scheduled platform maintenance or system downtime.

⚠️To minimize data entry or interpretation errors, all manually entered information (e.g., metadata, phenotype, treatment fields) should be carefully reviewed, and any manually modified reporting content should undergo independent verification.

⚠️ To avoid reporting integrity issues, users must not use unauthorized third-party tools to generate or alter Franklin reports, as such use violates the platform’s terms of service and may result in inaccurate or non-compliant outputs.

⚠️ To prevent formatting or delivery errors in finalized reports, organizations should test their custom reporting templates with sample cases prior to go-live and verify that key fields are rendered correctly.

⚠️ Users should be aware that unplanned service interruptions (e.g., due to regional internet disruptions) may occasionally occur and are outside the control of Genoox.

⚠️ If a user begins uploading a sample to a case, the sample must be fully uploaded and confirmed before proceeding. Attempting to interpret or submit incomplete cases may cause workflow disruption.

⚠️ Ensure that each case includes an attached sample. A generated case without a sample cannot proceed through analysis.

⚠️ Mandatory fields throughout the platform must be completed accurately. Skipping required fields may prevent submission, processing, or downstream validation.

This category includes warnings and precautions related to service availability, data input integrity, use errors and system responsiveness:

⚠️ To avoid incomplete or inaccurate reports, verify that all configured virtual panels (soft or hard panels) are correctly designed and validated with test samples prior to initial clinical use to ensure expected variant capture.

⚠️ To resolve any technical or behavioral issues promptly, report any unexpected platform behavior through the Franklin support. Users should also reach out if access issues, license clarifications, or end-user agreement concerns arise.

⚠️ If Franklin appears to be operating slowly, conduct a speed test to evaluate internet performance. If no issue is found on the user side, contact technical support for further investigation.

⚠️ Although Franklin APIs are thoroughly tested, there is a remote possibility of unexpected behavior or incorrect output due to broken external links or malformed responses. Therefore, any reports generated through API workflows should be independently reviewed for completeness and accuracy.

⚠️ If variant history or audit trails appear incomplete, notify Franklin support immediately for investigation.

⚠️ Be aware that genomic data formats are not universally standardized. Equivalent variants may appear differently across different interfaces or outputs within Franklin, depending on reference builds, alignment methods, or transcript annotations.

⚠️ During case processing, the system may display a "case still processing" notice. Wait until analysis is complete before proceeding with interpretation or reporting.

⚠️ If interpretation changes are made within a popup interface, they must be saved manually. Clicking outside the interface or navigating away without saving will discard changes.

⚠️ When using Franklin’s search interface, only supported input formats should be used. Submitting unsupported or malformed entries may result in no results or incorrect behavior.

This category includes warnings and best practices to help prevent unauthorized access, protect sensitive data, and maintain system integrity:

⚠️ Never share your Franklin login credentials, and do not reuse the same password across multiple systems.

⚠️ Enable two-factor authentication (2FA) for added protection, ensuring that even if login credentials are compromised, account access remains restricted.

⚠️ Never store credentials in plain text; use secure, encrypted password managers or storage mechanisms.

⚠️ Ensure your systems are protected against malware and other threats to avoid uploading corrupted or malicious input files into the Franklin platform.

⚠️ Always lock your computer or workstation when not in use to prevent unauthorized access—even for brief absences.

⚠️ Be aware that in accordance with local regulations, users may be required to report serious incidents related to the platform to the manufacturer, its authorized representative, and relevant regulatory authorities, depending on the location of the user and/or patient.

⚠️ To maintain compliance and security, users must log into the correct environment (e.g., dedicated organizational vs. community). Using the wrong environment may affect access, data visibility, or audit trail integrity.

⚠️ For users accessing Franklin through Single Sign-On (SSO), sessions may time out after periods of inactivity. Re-login is required to resume access.

⚠️ User can only register using an authorized institutional email domain such as laboratory, hospital, university, organization etc. public email domains (e.g. Gmail, Hotmail, etc) won’t be accepted.

⚠️ After successfully logging into Franklin, there is no default system timeout. To prevent unauthorized access or data exposure, users should manually log out after completing their work or when stepping away from their desktop for an extended period.

⚠️ For those working on temporary desktops, it is recommended to use Incognito Mode before logging in and to close the browser tab once finished.