ASCO's New PARPi Guideline Exclusively Cites myChoice CDx

The most comprehensive tumor test to determine HRD status in patients with ovarian cancer

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

Highlights

FDA-approved for both first-line maintenance therapy and late line monotherapy for Zejula® (niraparib) for patients with ovarian cancer.

FDA-approved for first-line maintenance therapy for Lynparza ® (olaparib) for patients with ovarian cancer.

Turnaround Time

Results in 14 days or less

Used in multiple clinical trials

QUADRA, PRIMA, and PAOLA

Affordable

FDA approved with broad insurance coverage

What is MyChoice® CDx?

myChoice® CDx is the most comprehensive tumor test that determines HRD status in patients with ovarian cancer. This FDA-approved test helps provide information on the magnitude of benefit for PARP inhibitor therapy. HRD status is determined using two individual methods: BRCA1 & BRCA2 status that encompasses sequence variants and large rearrangements and Genomic Instability Status encompassing Loss of Heterozygosity, Telomeric Allelic Imbalance and Large-Scale state transitions across the entire genome. It is the only commercially available tumor test that has been designed to detect large rearrangements which account for 5% of all ovarian cancer mutations.

1

BRAC1 & BRAC2 Status

Sequence Variants

+

Large Rearrangements

  • Detection and classification of sequence variants and large rearrangements
  • Identification of somatic and germline variants present in the tumor

2

Genomic Instability Status

LOH

Loss of Heterozygosity

+

TAI

Telomeric Allelic Imbalance

+

LST

Large-Scale State Transitions
  • Comprehensive assessment of LOH, TAI, and LST across the entire genome

Hereditary Cancer and Tumor Testing - Why Use Both?

Using a hereditary cancer test as a part of the ovarian cancer workup can provide critical information about hereditary risk to make the best treatment decisions for your patient. You can receive both hereditary and tumor treatment answers in one order by using Myriad. Learn more below.

*Reflex testing is available upon request.

How to Order Hereditary and Tumor Testing in One Order

1

Patient Diagnosed with Ovarian Cancer

2

Complete myRisk® TRF and myChoice® CDx TRF

3

Collect myRisk® Sample and Informed Consent

4

Email/Fax the following:
  • – myChoice® CDx TRF
  • – Pathology Report
  • – Insurance Cards Front/Back

To myChoiceCDx@myriad.com
Fax: 801-883-8998

Myriads Customer Service team will request tumor samples from the Pathology lab

5

Send myRisk® TRF and blood or saliva sample to Myriad

6

10-14 days (after sample received) TAT for myChoice® and myRisk® Results

7

Review your results through MyriadPro

MyChoice® CDx FDA-approved drugs:

For more information on myChoice® CDx and how to order

myChoice® CDx Intended Use

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 targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1: Companion diagnostic indications

Tumor TypeBiomarkerTherapy
Ovarian CancerMyriad HRD (defined as deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score)Lynparza® (olaparib)
Zejula® (niraparib)

Detection of deleterious or suspected deleterious BRCA1 and BRCA2 mutations 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.