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FDA-approved companion diagnostic

Myriad myChoice CDx

NGS-based tumor assay that assesses homologous recombination deficiency (HRD) and BRCA1/2 variants in FFPE tissue to guide DNA repair–targeted treatment decisions.

Lab-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: HRD status (HRD score), BRCA1/2 pathogenic variants
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P190014/
Supplements
S003
Manufacturer
Myriad Genetics
Approval date
May 8, 2020
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HRD status (HRD score), BRCA1/2 pathogenic variants
What this test is

Myriad myChoice CDx is an FDA-approved, NGS-based companion diagnostic that analyzes DNA from FFPE tumor tissue to detect pathogenic BRCA1/2 variants and calculate a genomic instability score reflecting homologous recombination deficiency (HRD). Results classify tumors as HRD-positive or HRD-negative, helping identify patients who may benefit from DNA damage response–targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Ovarian CancerHRDDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability ScoreLYNPARZA

Performing lab

Myriad Genetics

Myriad Genetic Laboratories – Myriad West (46D2275645)

Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forMyriad myChoice CDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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