Approval of myriad mychoice® cdx. Myriad mychoice® cdx is a next generation sequencing-based in vitro diagnostic test that assesses the qualitative detection and classification of single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon boundaries of the brca1 and brca2 genes and the determination of genomic instability score (gis) which is an algorithmic measurement of loss of heterozygosity (loh), telomeric allelic imbalance (tai), and large-scale state transitions (lst) using dna isolated from formalin-fixed paraffin embedded (ffpe) tumor tissue specimens. The results of the test are used as an aid in identifying ovarian cancer patients with positive homologous recombination deficiency (hrd) status for treatment with the targeted therapy listed in table 1 in accordance with the approved therapeutic product labeling. Table1---tumor type: ovarian cancer, biomarker: myriad hrd (defined as deleterious or suspected deleterious mutations in brca1 and brca2 genes and/or positive genomic instability score), therapy: zejula® (niraparib)
| Device | myChoice HRD CDx |
| Classification Name | Cancer-related Germline Gene Mutation Detection System |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | Myriad Genetic Laboratories, Inc |
| Date Received | 2019-05-03 |
| Decision Date | 2019-10-23 |
| PMA | P190014 |
| Supplement | S |
| Product Code | PJG |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190014 | Original Filing | |
| S007 | 2022-10-17 | Special (immediate Track) |
| S006 | 2021-06-07 | Normal 180 Day Track |
| S005 | 2021-05-28 | Special (immediate Track) |
| S004 | 2020-07-28 | Normal 180 Day Track |
| S003 | 2020-02-11 | Normal 180 Day Track |
| S002 | 2020-02-05 | Real-time Process |
| S001 | 2020-01-23 | Normal 180 Day Track |