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We offer an extensive portfolio of diagnostic tests for use in clinical trials, research studies and retrospective studies. Our testing results can help determine patient eligibility for a clinical trial, stratify patient cohorts and inform drug development research.
Clinical trials, including those for therapies targeting DNA damage response such as PARP inhibitors, can utilize our FDA-approved MyChoice® CDx or BRACAnalysis CDx® tests. Upon completion, we can pursue CDx claims for new drugs and indications. The benefits? Faster results and the best chance of supporting drug approvals with CDx claims.
Results of our tests can help:
Determine patient eligibility for a clinical trial
Stratify patient cohorts
Inform drug development research
HRD Companion Diagnostic Test
Determines homologous recombination deficiency (HRD) status for patients with ovarian cancer using MyChoice CDx, the first and only FDA-approved, NGS-based IVD tumor test
Germline Companion Diagnostic Test
Identifies patients with deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes who may be eligible for certain targeted therapies, the first and only FDA-approved CDx test of its kind
Advancing genomic profiling, including HRD testing Myriad and Illumina are working together to advance comprehensive genomic profiling plus homologous recombination deficiency testing using the globally distributed Illumina TruSight Oncology 500 (TSO 500) and TSO 500 HRD assay (for Research Use Only).
HRD CDx partnerships Myriad and Illumina will also seek joint HRD companion diagnostics partnerships with pharmaceutical companies worldwide, excluding Japan. Our CDx alliance will aim to pursue HRD CDx claims for both the MyChoice HRD assay companion diagnostic and a future clinical in vitro diagnostic test based off the TSO 500 HRD assay.
Clinical trial testing Leveraging Illumina’s in-development IVD solution, TruSight Oncology Comprehensive test (TSO Comp), Myriad can now offer prospective clinical trial testing with an Investigational Use Only test, enabling partnerships with leading pharmaceutical companies and academic institutions to further development of companion diagnostics.
Myriad’s experienced clinical project management team manages day-to-day operations, guiding you from the setup phase through sample management, reporting and data transfers. Your successful clinical trial is our ultimate goal — every time.
With labs in the U.S. and a partnership in China, samples from around the world can be tested to ensure the most comprehensive insights into your clinical trials. Regardless of where your patients are, we can perform molecular profiling services and deliver rapid information about the performance of your candidate therapy.