Modal Nova (Nova) provides physician-ordered clinical genetic testing services.

• Clinical laboratory testing is performed by Broad Clinical Labs, a CLIA-certified and CAP-accredited clinical laboratory, under Broad Clinical Labs' applicable laboratory certifications, accreditation, quality systems, and laboratory oversight. 

  • CLIA Number: 22D2055652 CAP Number: 8707596

• Nova’s laboratory director is Tootie Tatum, PhD. 

  • CAP Number: 9619501 CLIA Number: 45D2281059

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Genetic tests provided by Modal Nova (Nova) are performed in a CLIA-certified and CAP-accredited laboratory and are intended for clinical use.

• Nova performs physician-ordered clinical genetic testing. These are laboratory-developed tests (LDTs) developed and validated by Nova.

• Testing is conducted under laboratory quality systems designed to ensure accurate, reliable, and timely results.

• Each test was developed, and its performance characteristics were determined by Nova. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

• Nova reports provide clinical laboratory findings.

  • Results are reviewed and approved by qualified laboratory professionals, which may include laboratory directors, variant scientists, and genetic counselors.

  • Results may help support diagnosis, risk assessment, medical management, and family counseling. They should be interpreted by the ordering healthcare provider in the context of the patient’s medical history, physical findings, family history, and other test results.

  • The patient’s healthcare provider is responsible for making the final diagnosis and treatment decisions.

• Genetic testing has limitations.

  • A negative result does not exclude an underlying genetic cause.

  • A variant of uncertain significance does not confirm a diagnosis and generally should not be used alone to guide medical management.

  • Additional testing or future reinterpretation may be recommended.

• Patient-friendly summaries supplement the clinical report.

  • Nova may provide an easy-to-understand summary to help patients and families understand their results.

  • This summary is for educational purposes only. It is not genetic counseling and should not replace genetic counseling, medical consultation, or the official clinical laboratory report.

• Nova’s laboratory-developed tests have not been cleared or approved by the U.S. Food and Drug Administration.