MyRisk

The test may be considered for women and men with a personal or family history of cancer. It is intended to assess hereditary risk, not to confirm that a person currently has cancer.

A genetic finding may help the doctor discuss closer surveillance, prevention options or counselling for family members. Specific actions depend on the finding and the clinical situation.

• Myriad Europe: purpose of MyRisk testing

Before the consultation, it is useful to gather information about which cancers relatives have had, their age at diagnosis and which side of the family they belong to. If you have previous genetic test results, bring them with you.

The manufacturer’s European request form asks for personal history and the medical histories of maternal and paternal relatives separately. It notes that without accurate clinical data, some parts of the risk assessment report may not be provided.

• MyRisk Plus European form (2022, English)

The MyRisk result combines genetic test data with personal and family medical history. The doctor assesses the need for further care both when a significant genetic change is found and when none is found. Family history remains important in both cases.

A doctor assesses whether the test is suitable and interprets the results. A single result does not replace an individual surveillance or treatment plan.

• Myriad Europe: purpose of MyRisk testing

RiskScore combines clinical risk factors, family history and genetic risk markers. It is a separate part of risk assessment and must not be equated with identifying an inherited pathogenic variant.

RiskScore is described on Myriad’s European website and in the supplied MyRisk Plus (Europe) and MyRisk (ROW) request forms. It is an additional breast cancer risk assessment for women who meet specified criteria. Whether it is included in a particular order and what data is required are agreed before testing.

• Myriad information about MyRisk and RiskScore (USA, English)

Myriad provides separate MyRisk Plus (Europe) and MyRisk (ROW) request forms. The test scope, additional risk assessments and sample requirements are agreed according to the version selected.

The 2022 European MyRisk Plus form describes gene sequencing and large rearrangement analysis using DNA from peripheral blood, saliva or fibroblast samples. This is information from that document; the appropriate sample and current submission conditions must be agreed before ordering.

Before testing, the genes to be analysed and the additional risk information to be provided are clarified. The gene list published on the US website does not automatically apply to a European MyRisk Plus order.

• MyRisk Plus (Europe) form, 2022
• MyRisk (ROW) form, 2022
• Myriad US gene table — regional information

The 2015 publication by Judkins and colleagues examines analytical validation of the 25-gene panel used at that time. This study helps explain the basis of the testing methods but does not confirm the composition of the current European panel.

Before sending a sample, the selected test version, sample requirements, clinical data and informed consent documents must be confirmed. US ordering, reimbursement or remote consultation arrangements are not presented here as PharmaDNA services.

• Judkins et al., 2015 — validation of a 25-gene panel
• Myriad European MyRisk information
• Additional Myriad information for clinicians (USA)