MyChoice® CDx Myriad HRD Companion Diagnostic Test

Companion Diagnostic

MyChoice® CDx Myriad HRD Companion Diagnostic Test is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.

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Clinical Use

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Use

Myriad myChoice® CDx is an NGS-based in vitro diagnostic test performed on DNA isolated from FFPE tumor tissue specimens that detects and classifies BRCA1/BRCA2 variants (SNVs, indels, and large rearrangements) and determines a Genomic Instability Score (GIS) (algorithmic measurement of LOH, TAI, and LST). The results are used as an aid in identifying ovarian cancer patients with positive homologous recombination deficiency (HRD) status for treatment with the targeted therapy(ies) listed in the FDA labeling (e.g., Zejula® (niraparib); FDA labeling also includes maintenance Lynparza® (olaparib) in a later PMA supplement).

Special Instructions

Submit FFPE tumor tissue; blocks are preferred over slides whenever possible. Include the completed Test Request Form (TRF) and pathology report in the kit. Myriad provides a tumor specimen collection/transport kit; shipping instructions include use of provided packaging (and the kit includes an ice pack that is frozen prior to shipping). Specimen retrieval can be coordinated through Myriad per the TRF.

Limitations

This assay is for professional use only and is performed only at Myriad Genetic Laboratories, Inc. using FFPE tumor tissue. Results reflect findings from analyzable regions and may or may not reflect germline status; follow-up germline testing may be appropriate. Detected variants may not be present in all tumor cells. Testing success depends on adequate tumor content/quantity in the submitted FFPE specimen per submission requirements. Results should be interpreted alongside other clinical and diagnostic information and the approved therapeutic product labeling.

Test Details

FDA Approved

Companion Diagnostic