This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Myriad myChoice® CDx
PMA Applicant: Myriad Genetic Laboratories, Inc.
Address: 320 Wakara Way, Salt Lake City, UT 84108
Approval Date: October 23, 2019
Approval Letter: Approval Order
What is it? The myChoice CDx is a laboratory test that detects homologous recombination deficiency (HRD) status. A positive HRD status means that there are mutations in BRAC1 and BRCA2 genes or a high Genomic Instability Score (GIS) in patients with ovarian cancer. With a positive HRD status, a patient’s DNA is unable to repair.
When patients with ovarian cancer test positive for HRD, the doctor can determine if they are eligible for treatment with Zejula® (niraparib).
How does it work?
The doctor takes a small amount of cancer tissue from a patient’s tumor and sends it to a lab. The lab isolates DNA from the patient’s tumor tissue and mixes with substances (called reagents) to create chemical reactions to determine DNA sequences. The patient’s DNA sequences are then evaluated for changes in BRCA1 and BRCA2 genes. Additionally, the test is designed to determine Genomic Instability Score (GIS).
The doctor uses information from the patient’s test results to help manage ovarian cancer patient treatment. The presence mutations in BRCA1 and BRCA2 genes or a high GIS (positive HRD status) indicates that a patient with ovarian cancer is eligible for treatment with Zeluja® (niraparib).
When is it used? Doctors use myChoice CDx to determine if a patient with ovarian cancer is eligible for treatment with Zejula® (niraparib).
What will it accomplish? The myChoice CDx test helps doctors determine whether patients with ovarian cancer are eligible for treatment with Zejula® (niraparib).
When should it not be used? There are no known reasons for not having the test done.
Additional information (including warnings, precautions, and adverse events):