Myriad Genetics partners with pharmaceutical companies, biotechnology companies, clinical research organizations (CROs), and academic researchers to provide genomic testing and companion diagnostic services.
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. Myriad’s experienced clinical project management team offers full sample testing support including sample management and data transfer services. Our team will work closely with you to ensure a successful clinical trial.
Myriad has been an innovator in the development and commercialization of companion diagnostic tests. We have developed two FDA-approved companion diagnostic tests: BRACAnalysis CDx® and MyChoice® CDx, which allow for the identification of patients that may be eligible for treatment with PARP inhibitors. Myriad Genetics’ network of global partner laboratories support the commercialization of companion diagnostics upon their approval.
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.
Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with specific targeted therapies in accordance with the approved therapeutic product labeling.
Myriad MyChoice CDx is a next generation sequencing-based in vitro diagnostic test that assesses the qualitative detection and classification of single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes and the determination of Genomic Instability Score (GIS) which is an algorithmic measurement of Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
The results of the test are used as an aid in identifying ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible, because of a positive test result for deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes, or may become eligible, because of a positive test result for deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes or a positive Genomic Instability Score, for treatment with specific targeted therapies in accordance with the approved therapeutic product labeling.
August 11, 2022