Myriad myChoice CDx
by Myriad Genetic Laboratories, Inc.
PMA P190014
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP190014 | Date23 Oct 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- myChoice CDx
- Trade Name
- myChoice HRD CDx
- Generic Name
- Cancer-related germline gene mutation detection system
- PMA Number
- FDA Product Code
- PJG
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Myriad myChoice CDx is a next-generation sequencing-based in vitro diagnostic test classified as a Cancer-Related Germline Gene Mutation Detection System (PMA P190014). It detects and classifies single nucleotide variants, insertions, deletions, and large rearrangement variants in the BRCA1 and BRCA2 genes, alongside determining a Genomic Instability Score (GIS) from DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. The test aids in identifying ovarian cancer patients with homologous recombination deficiency (HRD) status, supporting treatment decisions for targeted therapies like Zejula® (niraparib).
This device is intended for laboratory use and requires DNA extracted from FFPE tumor samples. It is not a single-use or reusable device but operates under regulatory approval via an FDA Premarket Approval (PMA). The test results are algorithmically derived from genomic instability metrics, including Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST). Compliance with FDA guidelines ensures its clinical utility in oncology diagnostics, specifically for ovarian cancer management.
Questions
AI-generated answers, 18 Sep 2026
What types of genetic variants does the myChoice CDx test detect in BRCA1 and BRCA2 genes, and how does it use this information for ovarian cancer patients?
The myChoice CDx detects single nucleotide variants, insertions, deletions, and large rearrangement variants in the BRCA1 and BRCA2 genes. It also calculates a Genomic Instability Score (GIS) based on genomic instability metrics like Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST). This helps identify ovarian cancer patients with homologous recombination deficiency (HRD) status, guiding treatment decisions for targeted therapies such as Zejula® (niraparib).
Is the myChoice CDx designed for use with specific types of tissue samples, and what preparation is required before testing?
Yes, the myChoice CDx is designed to work with DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. The test requires extracted DNA from these samples, so proper FFPE tissue processing and DNA isolation are necessary before analysis.
How is the myChoice CDx regulated, and what does its FDA approval cover?
The myChoice CDx holds an FDA Premarket Approval (PMA) under the designation P190014. Its approval covers the qualitative detection and classification of genetic variants in BRCA1 and BRCA2, along with the determination of a Genomic Instability Score (GIS) for ovarian cancer patients. This aids in identifying HRD status to support treatment decisions for targeted therapies like Zejula® (niraparib).
Does the myChoice CDx provide a single result or multiple metrics, and how are these used clinically?
The myChoice CDx provides multiple metrics, including the detection of BRCA1/BRCA2 variants and a Genomic Instability Score (GIS), which combines measurements like LOH, TAI, and LST. Clinically, these results help determine HRD status in ovarian cancer patients, assisting in decisions for therapies such as Zejula® (niraparib) based on the approved therapeutic labeling.