Myriad hrd3/30/2024 Additionally, the test is designed to determine Genomic Instability Score (GIS). The patient’s DNA sequences are then evaluated for changes in BRCA1 and BRCA2 genes. 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 doctor takes a small amount of cancer tissue from a patient’s tumor and sends it to a lab. When patients with ovarian cancer test positive for HRD, the doctor can determine if they are eligible for treatment with Zejula® (niraparib). With a positive HRD status, a patient’s DNA is unable to repair. 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. What is it? The m圜hoice CDx is a laboratory test that detects homologous recombination deficiency (HRD) status. PMA Applicant: Myriad Genetic Laboratories, Inc.Īddress: 320 Wakara Way, Salt Lake City, UT 84108 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. This is a brief overview of information related to FDA’s approval to market this product.
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