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Abstract Textures

Regulatory Notes

  • Nova functions as a clinical support and documentation tool, not as a diagnostic device.

    • Layperson educational readings are reviewed and validated by qualified genetic professionals including variant scientists, medical directors and genetic counselors before delivery.​

  • Nova does not make diagnoses or probabilistic risk assessment.

    • Nova collaborates with U.S.-based clinical laboratories that are CLIA-certified and CAP-accredited, as well as licensed healthcare providers.

    • Our process starts from clinical reports delivered by genetic testing laboratories.

    • Our process may flag limitations in the data and prompt patients to clinical follow-up with their health care providers, which is consistent with FDA guidance for non-directive reporting.

  • Nova reports are explicitly marked as educational, not intended for use in diagnostic procedures.

    • Every report includes clear disclaimers encouraging users to consult with a licensed provider or genetic counselor.​

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