1. 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 ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza™ (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.
Myriad myPath™ Melanoma is a unique molecular test created specifically for difficult-to-diagnose melanoma cases. By analyzing 23 genes, the test provides valuable additive molecular information unavailable from any other method for a more informed diagnosis.
Prolaris® measures the expression level of genes involved with tumor proliferation, providing physicians with unique additional information about a patient’s prostate cancer prognosis and may be used with other clinical factors - providing valuable insight into treatment planning.
Myriad ResultsNow™ electronically delivers Myriad test results. Easily view your patient’s test results from anywhere there is an internet connection. View from your office, home, on any hand-held device.
Both BRACAnalysis and BRACAnalysis CDx sequence the BRCA1 and BRCA2 genes to determine if there are mutations in either of these genes. BRACAnalysis CDx is the only FDA approved laboratory developed test that indicates whether or not a patient with ovarian cancer may be eligible for treatment with Lynparza™ (olaparib). A positive BRACAnalysis CDx result in patients with ovarian cancer is also associated with enhanced progression-free survival (PFS) from Zejula™ (niraparib) maintenance therapy.
Myriad’s BRCA test was used to analyze samples in the clinical trials that led to the approval of Lynparza and Zejula. On that basis, the BRACAnalysis CDx test received FDA approval to inform patient management related to the PARP inhibitors Lynparza and Zejula. The FDA submission consisted of:
A small amount of blood is drawn and the sample is sent to Myriad for DNA sequencing and large rearrangement analysis of BRCA1 and BRCA2. Following analysis, variants are classified and a report is generated and sent to the ordering health care provider.
Myriad myRisk® and CLIA BRACAnalysis® test both provide options for physicians in assessing BRCA status, but Myriad can only market BRACAnalysis CDx as the FDA approved BRCA testing for Lynparza and Zejula per regulation. If a patient’s BRCA status has been previously determined, it is at the physician’s discretion in the practice of medicine to retest or not. Factors that may influence whether a patient is retested include whether the patient had full sequencing and large rearrangement testing when their original test was performed.
BRACAnalysis CDx is the only FDA approved BRCA testing for Lynparza and Zejula. Patient samples submitted to Myriad that have been previously tested through another laboratory will receive the BRACAnalysis CDx test.
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