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With Myriad, you gain an innovative, practical, and responsive CDx lab partner, focused on delivering value.
From custom assay development through global regulatory clearance and commercialization, we have the deep expertise required to deliver results every step of the way.
Assaydevelopment
Sampletesting
Testvalidations
Regulatorysupport
Establishedcommercialization
Working closely with regulatory agencies worldwide, Myriad has secured approvals for 10 companion diagnostics (CDx) claims in the U.S. and Japan, as well as CE marking in Europe. In China, we support clinical trials using MyChoice® CDx testing.
Your partner in CDx development should go far beyond an assay design. Using our centralized testing operations, pre-existing sales and marketing infrastructure, and key laboratory partnerships, Myriad helps drive your CDx test and your therapy across the finish line and into the market.
Combining our strengths in assay development, clinical testing and regulatory approvals, our partnership with QIAGEN offers pharma partners comprehensive global development of lab-developed and/or distributable kit-based companion diagnostic tests.
By leveraging our respective strengths in HRD and comprehensive genomic profiling, we seek to broaden clinical research opportunities to drive CDx development for gene-based therapies worldwide.
Myriad has a proven track record of successful CDx test development, offering two FDA-approved CDx tests.
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