myChoice CDx

FDA Premarket Approval P190014 S001

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.

Pre-market Approval Supplement Details

Approval for extending the label claim to include an additional indication for zejula® (niraparib) maintenance therapy. The device, as modified, will be marketed under the trade name myriad mychoice® cdx and is indicated for: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, 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 zejula® (niraparib). Detection of deleterious or suspected deleterious brca1 and brca2 and/or positive genomic instability score in ovarian cancer patients is also associated with enhanced progression-free survival (pfs) from zejula® (niraparib) maintenance therapy. This assay is for professional use only and is to be performed only at myriad genetic laboratories, inc. , a single laboratory site located at 320 wakara way, salt lake city, ut 84108.

DevicemyChoice CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantMyriad Genetic Laboratories, Inc
Date Received2020-01-23
Decision Date2020-04-29
Product CodePQP 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108

Supplemental Filings

Supplement NumberDateSupplement Type
P190014Original Filing
S003 2020-02-11 Normal 180 Day Track
S002 2020-02-05 Real-time Process
S001 2020-01-23 Normal 180 Day Track

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