This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the final revised labeling (iu) for the myriad mychoice® cdx. The device 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 who are eligible, because of a positive test result for deleterious or suspected deleterious mutations in brca1 or brca2 genes, or may become eligible, because of a positive test result for deleterious or suspected deleterious mutations in brca1 or brca2 genes or a positive genomic instability score, for treatment with the approved targeted therapy for zejula® (niraparib).
| Device | myChoice CDx |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Myriad Genetic Laboratories, Inc |
| Date Received | 2020-02-05 |
| Decision Date | 2020-03-23 |
| PMA | P190014 |
| Supplement | S002 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |