Shots:
- The US FDA has approved MyChoice CDx Test as a companion diagnostic for for HRD+ identification in pts with advanced ovarian cancer who may benefit from treatment with Zejula (niraparib)
- Approval was based on the PRIMA trial assessing Zejula vs PBO in ovarian cancer pts with complete or partial response to 1L Pt-based CT, where the MyChoice CDx test assessed HRD status to stratify pts & guide PARP inhibitor therapy
- MyChoice CDx determines HRD status using next generation sequencing to assess BRCA1/2 genes, incl. large rearrangements & tumor genomic instability score that incl. loss of heterozygosity, telomeric allelic imbalance & large-scale state transitions
Ref: Globenewswire | Image: Myriad Genetics | Press Release
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