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myCHOICE® CDx Plus GR

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myCHOICE CDx® Plus – The most comprehensive HRD tumor test to guide PARP inhibitor treatment decisions.

 

 

Homologous Recombination Deficiency (HRD) is present in approximately 48% of ovarian cancer tumorsand is associated with sensitivity to PARPi therapy.2

International guidelines include recommendations for HRD testing for ovarian cancer.2,3

 

 

  1. The Cancer Genome Atlas. Nature 2011
  2. Miller et al. Annals of Oncology (2020) in press:https://doi.org/10.1016/j.annonc.2020.08.2102
  3. Tew et al. JCO (2020) in press:https://ascopubs.org/doi/pdf/10.1200/JCO.20.01924

 

 

The first FDA-approved tumor test that determines HRD status using BRCA status and Genomic Instability Status

 

Results in 14 days or less   

Used In Multiple Clinical Trials   QUADRA, PRIMA, and PAOLA

 

48% will have a positive myCHOICE CDx Plus result

39%1 HRD+ due to mutations in BRCA1 or BRCA2

61%1 HRD+ due to other causes resulting in Genomic Instability

1.Moore et. al, Lancet Oncol 2019

 

 

 

 

 

 

 

 

 

What is Myriad myChoice® CDx Plus?

 

myChoice® CDx Plus is the most comprehensive tumor test that determines HRD status in patients with ovarian cancer, fallopian tube and primary peritoneal cancer. This CE marked test helps to identify ovarian cancer patients with a Homologous Recombination Deficiency who might be considered for treatment with PARPi therapy.

HRD status is determined using two individual methods: BRCA1 & BRCA2 status that includes sequence variants and large rearrangements and Genomic Instability Status encompassing Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI) and Large-Scale State Transitions (LST) measured across the entire genome. It is the only commercially available tumor test that has been designed to detect these 3 biomarkers of genomic instability. In addition, the test assesses both pathogenic variants and pathogenic large rearrangements which account for ~5% of all BRCA mutations in ovarian cancer.

 

 

 

 

 

myChoice® CDx Plus Intended Use

 

Myriad myChoice® CDx Plus is used to detect Homologous Recombination Deficiency (HRD) by assessing the Genomic Instability Status and the Tumor Mutation BRCA1/BRCA2 Status in genomic DNA extracted from tumor specimens. Results are used as an aid to determine the eligibility of patients with ovarian cancer for treatment with certain Poly-ADP Ribose Polymerase (PARP) inhibitors in accordance with the approved therapeutic product labeling.

Additionally, sequencing and large rearrangement analyses are performed on all analyzable regions of the following genes that have been analytically validated using multiple cancer types: ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L.

 

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.

 

For more information please call us or visit www.myriad-oncology.com

 

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