SALT LAKE CITY, March 17, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice® CDx Test as the Companion Diagnostic (CDx) for Zejula® (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer.
This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency (HRD) status and was used to stratify advanced ovarian cancer patients.
The MyChoice CDx is the only FDA-approved companion diagnostic test in the United States to identify patients with HRD-positive status eligible for treatment with Zejula. The test determines HRD status by leveraging next generation sequencing technology to conduct a comprehensive assessment of BRCA1/2 genes -- including large rearrangements -- and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST).
“The FDA approval reinforces Myriad’s long-standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing,” said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. “By enabling precise identification of patients who may benefit from PARP inhibitors, MyChoice CDx helps ensure that treatment decisions are guided by robust genomic insights.”
Nearly 50% of patients with advanced ovarian cancer have HRD positive (HRD+) tumors.1 Identifying these patients is critical to ensuring appropriate use of PARP inhibitor therapy and improving personalized treatment decisions.1-4
Zejula is a prescription medicine used for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer is associated with HRD+ status defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability. Zejula is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy (Zejula indications referenced here apply to the US only). (For other indications, see “About Zejula” section below).
To learn more about the MyChoice CDx Test and how it can support treatment decisions for patients eligible for Zejula, please visit https://myriad.com/genetic-tests/mychoicecdx-tumor-test.
About the MyChoice CDx Test
The MyChoice® CDx Test is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in American Society of Clinical Oncology (ASCO) guidelines for selecting patients with ovarian cancer who may benefit from poly [ADP-ribose] polymerase (PARP) inhibitors.5 The MyChoice CDx Test determines HRD status by conducting a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST). The MyChoice CDx Test can identify 34% more patients with HRD than other tumor tests that use %LOH alone.1
About Zejula (niraparib)
Zejula is an oral, once-daily poly (ADP ribose) polymerase (PARP) inhibitor that works by preventing DNA repair in tumor cells, ultimately leading to their death. Zejula is indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
Zejula is also indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula (Zejula indications referenced here apply to the US only).
Please see the US Prescribing Information for Zejula.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic and precision medicine company committed to advancing health and well-being for all. Myriad Genetics develops and commercializes molecular tests that help patients and providers uncover genetic insights. Myriad Genetics tests assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care, support earlier detection, enable more precise treatment and contribute to lowering healthcare costs. For more information, visit www.myriad.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements that this FDA approval reinforces the company’s long-standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing, and that, by enabling precise identification of patients who may benefit from PARP inhibitors, MyChoice CDx helps ensure that treatment decisions are guided by robust genomic insights. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 24, 2026, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.
- Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov. 2015;5(11):1137-1154.
- Timms KM, Abkevich V, Hughes E, et al. Comparison of genomic instability test scores used for predicting PARP activity in ovarian cancer. J Clin Oncol. 2020;38(15_suppl):1586.
- da Cunha Colombo Bonadio RR, Fogace RN, Miranda VC, Diz MDPE. Homologous recombination deficiency in ovarian cancer: a review of its epidemiology and management. Clinics (Sao Paulo). 2018;73(suppl 1):e450s.
- Watkins JA, Irshad S, Grigoriadis A, Tutt AN. Genomic scars as biomarkers of homologous recombination deficiency and drug response in breast and ovarian cancers. Breast Cancer Res. 2014;16(3):211.
- Tew WP, Lacchetti C, Birrer MJ, et al. PARP inhibitors in the management of ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(30):3468-3493
Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com
Media Contact
Kate Schraml
(224) 875-4493
PR@myriad.com
