How do I test with Myriad myRisk®?
Myriad myRisk tests kits are available from your Myriad Account Executive. The test request form is similar to current Myriad test request forms: for patients meeting current testing criteria for Hereditary Breast and/or Ovarian Cancer syndrome, order “BRACAnalysis with Myriad myRisk® Hereditary Cancer.” For patients meeting testing criteria for Lynch/Polyposis Syndromes, order COLARIS/COLARIS AP with Myriad myRisk® Hereditary Cancer.
What criteria were used for the selection of genes in the Myriad myRisk panel?
Genes were selected by review of medical societal guidelines, cumulative studies, and discussion with experts in cancer genetics. Cancer risks in these genes have a minimum of 2-3 fold increase over the general population. Attention was focused on existing well defined cancer genetics syndromes, genes for which their contribution to adult cancer is well understood and newly discovered genes associated with inherited cancer. The genes analyzed with Myriad myRisk are APC, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A (p16INK4a and p14ARF), CHEK2, MLH1, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53.
How do you know the Myriad myRisk NGS platform is as sensitive as current BRACAnalysis®?
In a BRCA1 and BRCA2 comparison study NGS identified 15,877 sequence variants while Sanger sequencing identified 15,878. Based on these results, the NGS process was refined prior for the validation of the full gene panel. In the validation study, NGS and Sanger sequencing were 100% concordant for the 3,923 collective variants across all genes for an analytical sensitivity of the NGS assay of >99.92% and analytical specificity >99.99% (lower limit of 95% confidence interval) . Myriad myRisk is shown in additional validation to be highly effective and provided accurate results equivalent to those obtained from Sanger DNA sequencing analysis.
Who is appropriate for Myriad myRisk Hereditary Cancer?
Is buccal sampling available with Myriad myRisk Hereditary Cancer?
Yes. Similar to previous Myriad hereditary cancer tests, both buccal and blood samples are thoroughly validated and accepted. There is no difference in result outcome between the two sample submission options.
What is the turnaround time for Myriad myRisk Test Report?
The majority of myRisk results are completed within 14 days. We will notify you in the unusual event that results are taking longer than 21 days.
What are the options for STAT patients with pending surgery who can't wait 14-21 days?
Currently myRisk cannot be run as a STAT test for patients awaiting surgical decisions. Because Myriad myRisk has been shown to increase mutation sensitivity by 40-50% in appropriate patients it may be helpful to convey to your patients that a mutation in another gene may impact their management and surgical treatment plan.
What are the references for the myRisk Test Report medical medical management recommendations?
The myRisk Management Tool reference the National Comprehensive Cancer Network (NCCN), International Cancer of Pancreas Screenings (CAPS), Claus breast cancer risk model, Amsterdam Criteria, and others to provide medical management considerations. For example, patients with family histories and/or a gene mutation that is associated with >20% lifetime risk for breast cancer will be presented with NCCN based consideration of improved breast screening.
Will update testing be available for patients with previous comprehensive Myriad testing?
Myriad myRisk update testing will soon be available for all patients who previously tested negative with BracAnalysis and COLARIS.
What is the out of pocket cost for Myriad myRisk?
Myriad Promise™ is available to all patients who order Myriad myRisk. If patient cost for the test will be more than $375, a Myriad customer service representative will contact them to discuss payment options. If your patients have concerns when they receive an invoice from Myriad, they can call the telephone number on the invoice. We guarantee that we will work together to reach a solution. Patients without insurance or who are underinsured may apply for Myriad’s Financial Assistance Program (MFAP).