


Regulatory Notes
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Nova functions as a clinical support and documentation tool, not as a diagnostic device.
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Layperson educational readings are reviewed and validated by qualified genetic professionals including variant scientists, medical directors and genetic counselors before delivery.
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Nova does not make diagnoses or probabilistic risk assessment.
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Nova collaborates with U.S.-based clinical laboratories that are CLIA-certified and CAP-accredited, as well as licensed healthcare providers.
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Our process starts from clinical reports delivered by genetic testing laboratories.
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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.
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Nova reports are explicitly marked as educational, not intended for use in diagnostic procedures.
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Every report includes clear disclaimers encouraging users to consult with a licensed provider or genetic counselor.
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