myRisk^® with riskScore^® – A hereditary cancer panel with a polygenic risk score

Hereditary Cancer is a scientific advancement revolutionizing hereditary cancer testing in combination with riskScore®. Blending both genetic test status AND personal cancer family history, Myriad myRisk^® hereditary cancer panel represents the next generation of hereditary cancer risk testing. Myriad myRisk^® identifies elevated risk for 8 important cancers (breast, ovarian, colorectal, uterine, melanoma, gastric, pancreatic, prostate) by analyzing multiple, clinically significant genes. Additionally, Myriad myRisk^® provides a summary of available medical society guidelines to help you optimize your patients’ medical management. Be confident you know your patients’ cancer risks and appropriate follow-up management with Myriad myRisk® Hereditary Cancer.

myRisk® genes at https://myriadmyrisk.com/gene-table/

Myriad myRisk^® simplifies the test selection process by providing you the most comprehensive hereditary cancer panel test with clinically significant results. Be confident you are testing for the primary clinically significant genes associated with your patients’ risk.

• Accuracy is everything when patient lives are at stake

• >99.92% sensitivity / >99.99% specificity ⁽¹⁾
• Technological innovations, several unique to Myriad (Pheno^®, MCO^®), have been developed over 20 years with 2.5 million patients tested
•  
• Myriad’s myVision^™Variant Classification program is considered the gold standard in the industry

• We employ over 30 medical professionals of varying disciplines who meet daily to classify and reclassify variants
• We use 8 published and peer-reviewed methodologies, 2 unique to Myriad that have >99% PPV or NPV ^(2,3,4)
• We classified over 10,000 variants in 2016, and sent over 400 reclassified results to providers every week
• Lifetime commitment to classification: We will provide you and your patients an updated result if a variant is reclassified, no matter when the original testing occurred

Responsible Stewards of the data

• Myriad is committed to protecting patient privacy and does not engage in activities that could compromise the privacy of an individual patient’s genetic information
• Myriad will always share an individual patient’s genetic test results with the patient, their provider and anyone else the patient designates access to
• Myriad shares data in a responsible fashion that respects patient privacy through peer-reviewed literature and scientific presentation, and is a founding member of the PROMPT registry.
• In a responsible effort to share data, Myriad has contributed more to the scientific literature via publication and presentation than any other hereditary cancer lab

References

• Judkins T et al. Development and analytical validation of a 25-gene next generation sequencing panel that includes BRCA1 and BRCA2 genes to assess hereditary cancer risk; BMC Cancer. 2014 Pruss D et al.

• Development and validations of a new algorithm for the reclassification of genetic variants identified in the BRCA1 and BRCA2 genes; Breast Cancer Research and Treatment. 2013 Morris B et al.

• Classification of genetic variants in genes associated with Lynch syndrome using a clinical history weighting algorithm; BMC Genetics. 2016 Bowles K et al.

• Reclassification of uncertain variants in high and moderate cancer risk genes using history weighting analysis; ACMG. 2016

• No other hereditary cancer testing laboratory has more experience than Myriad leading to the most accurate, fastest test results for patients.
• Published accuracy
• Fully automated processes
• Over 60% of mutations classified using Myriad’s unique methods
• Myriad has the only FDA reviewed variant classification process
• Lifetime commitment: When a variant is reclassified, Myriad will send an amended test report
• Over 20 years of experience
• Over 2,5 million patients tested for hereditary cancer

What to know when discussing test results with patients

 + Positive

• A genetic mutation was found in 1 or more of the genes tested
• The patient is at increased risk for cancer
• A summary of medical management guidelines will be provided specific to the patient’s gene mutation(s)
•  

 *  Elevated

• No genetic mutation was found in the genes tested
• The patient is at elevated risk for cancer based on an analysis of additional genetic markers, personal clinical risk factors, and/or their family’s history of cancer
• A summary of medical management guidelines will be provided based on the patient’s elevated risk

 –  Negative 

• No genetic mutation was found in the genes tested
• The common causes of hereditary cancer have been ruled out, but depending on family history of cancer, increased risks could still remain
• Depending on their family history, medical management is usually based on general population screening guidelines; however, discussion with your patient can determine if there are any changes in medical management that are most appropriate for them

 ?  Variant of Uncertain Significance (VUS)

• A change in a gene has been identified
• It is not yet known if the change is associated with increased cancer risk
• Medical management based on personal and family history of cancer until more is understood about the specific change

What is the myRisk^® Management Tool?

myRisk^® results include the myRisk^® Management Tool where the results evaluated according to leading scientific society guidelines for consideration of modified medical management. Your patient’s clinical history will also be included in an easy-to-read format to provide you and your patient with as much information as possible as you form a plan together.

riskScore^® is a clinically validated algorithm that predicts a women’s remaining 5-year and lifetime risk of developing breast cancer.

• What Is riskScore^®?

riskScore^® provides comprehensive, personalized risk assessment for certain women for a 5-year and remaining lifetime risk of developing breast cancer, analyzing several personalized factors at no additional cost.  

riskScore^® can provide further insight for certain women who remain high-risk without a pathogenic mutation. By incorporating over 80 well-studied and validated genetic markers with the Tyrer-Cuzick risk model, riskScore^® reports a 5-year and remaining lifetime risk for breast cancer. Women who receive a riskScore^® will have this information included in the myRisk^® Management Tool to assist in the development of a treatment plan.

Personalized Breast Cancer Risk Assessment For Women Without A Pathogenic Mutation

This means that certain patients will receive more critical information to help guide your medical management plan for breast cancer prevention and early identification.

Personalized Breast Cancer Risk For CHEK2 Mutation Carriers

Recommend a medical management plan based on the a woman’s personal risk of breast cancer instead of a range of risk associated with a pathogenic CHEK2 mutation. 

Current Eligibility For riskScore®

riskScore^® has been validated based on previously identified genetic markers that are specific to certain populations, cancer histories, and mutation statuses.

1. Woman under age 85 
2. European and Ashkenazi Jewish ancestry 
3. No personal history of breast cancer, LCIS, hyperplasia, atypical hyperplasia, or a breast biopsy with unknown results 
4. The woman does not have a mutation in a breast cancer gene (excluding monoallelic CHEK2) 
5. The woman’s relatives have not been found to have a mutation in a high-penetrance breast cancer risk gene.* 

*High-penetrance breast cancer risk genes: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, TP53, ATM c.7271T>G., and bi-allelic CHEK2

Scientific Publications

Please visit: https://myriadmyrisk.com/scientific-presentations/?product=1

For more information please call us or visit www.myriad-oncology.com or www.myriad-oncology.com