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What will it accomplish? The m圜hoice CDx test helps doctors determine whether patients with ovarian cancer are eligible for treatment with Zejula® (niraparib). When is it used? Doctors use m圜hoice CDx to determine if a patient with ovarian cancer is eligible for treatment with Zejula® (niraparib). 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).
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The doctor uses information from the patient’s test results to help manage ovarian cancer patient treatment. 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).
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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. The main goal of HRD activities relates to empowering and strengthening the capabilities of. As a subset of HRM, it aims at improving the skills, competencies, knowledge, behavior, and attitude of people working in a specific organization. What is it? The m圜hoice CDx is a laboratory test that detects homologous recombination deficiency (HRD) status. Human Resource Development is defined as the development of employees working in any organization. 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. Matthew Marton is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and has stock ownership interests in Merck & Co., Inc., Kenilworth, NJ, USA.This is a brief overview of information related to FDA’s approval to market this product. Ping Qiu is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and has stock ownership interests in Merck & Co., Inc., Kenilworth, NJ, USA. Gladys Arreaza is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and has stock ownership interests in Merck & Co., Inc., Kenilworth, NJ, USA.Ĭai Chen is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Īndrew Albright is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and has stock ownership interests in Merck & Co., Inc., Kenilworth, NJ, USA. Xiao Qiao Liu is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Razvan Cristescu is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and has stock ownership interests in Merck & Co., Inc., Kenilworth, NJ, USA. Disclosures This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.