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Oncology

myRisk can help determine the best treatment for your patient.
Myriad myRisk® can help you quickly and accurately determine available treatment options for patients. With industry leading turnaround time, accuracy, and variant classification, myRisk can provide vital information for you and your patients with an easy and affordable testing process.

Hereditary Cancer Testing Matters


Dr. Sharyn Lewin discusses how germline testing helps guide treatment decisions.


Dr. Gregory Vidal discusses how germline testing differs from tumor testing and how germline results can inform eligibility for treatment options.


Determine Available
Treatment Options
Germline testing can help determine PARP inhibitor eligibility, a therapy which can cut the risk of disease progression or death in the following cancer types:

Metastatic Breast

46%

PARPi can cut risk of disease progression or death up to 46% for HER2-negative metastatic breast patients with gBRCA mutation1

Ovarian

70%

PARPi can cut risk of disease progression or death up to 70% for ovarian cancer patients with a gBRCA mutation2

Pancreatic

47%

PARPi can cut risk of disease progression or death up to 47% for pancreatic cancer patients with a gBRCA mutation3

NCCN recommends germline testing in the workup for these affected patients4-6


Tumor Testing Cannot
Replace Germline Testing
Germline and tumor testing identify different biomarkers, and tumor testing differs in test coverage, variant classification, and detection of large rearrangements. In the SOLO-1 trial, 5% of known gBRCA mutations were not identified with tumor testing2. This impacts eligibility for treatment options!

Identify 2nd Cancer Risk
and Family Member Risk
Patients with hereditary cancer are at risk of developing a second primary cancer or cancer at another site7-9
This can also help family members better understand their risk and impact their medical management7,10-15.
Germline testing can help determine PARP inhibitor eligibility, a therapy which can cut the risk of disease progression or death in the following cancer types:

Metastatic Breast

46%

PARPi can cut risk of disease progression or death up to 46% for HER2-negative metastatic breast patients with gBRCA mutation1

Ovarian

70%

PARPi can cut risk of disease progression or death up to 70% for ovarian cancer patients with a gBRCA mutation2

Pancreatic

47%

PARPi can cut risk of disease progression or death up to 47% for pancreatic cancer patients with a gBRCA mutation3

NCCN recommends germline testing in the workup for these affected patients4-6

Germline and tumor testing identify different biomarkers, and tumor testing differs in test coverage, variant classification, and detection of large rearrangements. In the SOLO-1 trial, 5% of known gBRCA mutations were not identified with tumor testing2. This impacts eligibility for treatment options!
Patients with hereditary cancer are at risk of developing a second primary cancer or cancer at another site7-9
This can also help family members better understand their risk and impact their medical management7,10-15.

Easy Identification

Identifying patients who meet criteria has become easier than ever with simple indications for affected patients

cancer type
annual incidences
% hereditary
guidelines
Breast
271,270 incidences annually16
12-14% are hereditary17
100% meet criteria under ASBS guidelines18
Ovarian
22,530 incidences annually16
24% are hereditary19
100% meet criteria under NCCN guidelines20
Pancreatic
56,770 incidences annually16
10% are hereditary21
100% meet criteria under NCCN guidelines20
Prostate
174,650 incidences annually16
17% are hereditary22
All metastatic patients meet NCCN criteria20
Colorectal
101,420 incidences annually16
10% are hereditary23
All patients under age 65 meet NCCN criteria20
Uterine
61,880 incidences annually16
9% are hereditary24
All patients under age 65 meet NCCN criteria20

Myriad has tools to help you accurately identify patients


Can identify patients eligible for testing and jumpstart the ordering process

Can help identify and educate eligible patients and make for easy upload into EMR.

Affordable Testing

Accessible

97%

Affordable

75% ≥ 90%

Satisfied

100%

Combined with 97% of patients covered by insurance, Myriad's financial assistance programs* result in 75% of patients paying $0 and 90% paying $100 or less22. The Myriad Promise ensures that 100% of patients who test with Myriad are completely satisfied.

*Patients who are recipients of US government funded programs such as Medicaid, Medicare, Medicare-Advantage and Tricare may not be eligible for MFAP

Fast, Easy Ordering

 

Myriad myRisk has an industry leading turnaround time of 14 days or less on average with no reflex ordering required.

Myriad myRisk STAT for Pancreatic Cancer can give you faster results for patients who may become eligible for a PARP inhibitor:

  • BRCA 1/2, PALB2 and 8 other genes in 5-12 calendar days
  • Full panel and report within 14 calendar days or less. No reflex needed!

Accuracy Matters

Myriad is the industry leader in providing accurate results for patients. Through our unique, clinically validated techniques, Myriad provides answers other labs cannot25-28.

Learn more about Myriad's variant reclassification techniques and programs below

Why is variant
classification important?

Why is variant classification important?

Variant classification is a key component of germline testing, allowing patients to have an accurate answer when they receive a result and stay informed as new information leads to reclassification on a daily basis Tumor testing labs do not send amended reports or have variant classification programs, leading to a gap in patient care Myriad myRisk testing detects all mutation types with >99% accuracy, whereas tumor testing and other labs may not detect all mutations, including large rearrangements
Who else does variant
classification?

Who else does variant classification?

Other labs may have variant classification programs, but interpretive accuracy can vary greatly among labs29

Myriad has a diverse team of experts involved in variant classification, with review occurring daily

Myriad's Variant
Classification Program

myVision: Myriad's unmatched Variant Classification Program

myVision incorporates several proprietary, clinically validated tools as well as other advanced methods to provide the most comprehensive variant classification program available
  • Enhanced Methods
    • Literature Review: Myriad has an automated literature search engine and employs dedicated PHD level scientists to review the literature30
    • Population Analysis and Segregation Analysis: Myriad's optimized approach as described in Eggington, 201327
    • In Trans Co-Occurrence & Homozygosity: Demonstrated to be >99% accurate in Fernandes, 201531
    • Structural Biology Analysis: Myriad's approach described in Kerr, 201632
    • Functional RNA Splice Site Analysis: Myriad developed the first research laboratory dedicated to RNA analysis, the approach of which is described in Warf 201533
  • Advanced Methods Unique to Myriad
    • M-CO: Myriad's unique mutation co-occurrence statistical model was developed and validated with >400,000 patients and demonstrated to be >99% accurate in Coffee, 201534
    • Pheno: Myriad's unique family history weighting tool developed and validated for BRCA 1/2, MLH1, MSH2, MSH6, ATM, CHEK2, PALB2, and BARD1. Demonstrated to be 99% accurate in multiple publications35-37
myVision is a lifetime commitment to patients, with review of variants and updated amended reports sent out to patients daily38
  • 60,000+ amended reports between 2006 and 2016
  • 2,868 variants reclassified between 2006 and 2016
  • 9% of these reclassifications impacted recommended medical management

myVision: Myriad's unmatched Variant Classification Program

myVision incorporates several proprietary, clinically validated tools as well as other advanced methods to provide the most comprehensive variant classification program available
  • Enhanced Methods
    • Literature Review: Myriad has an automated literature search engine and employs dedicated PHD level scientists to review the literature30
    • Population Analysis and Segregation Analysis: Myriad's optimized approach as described in Eggington, 201327
    • In Trans Co-Occurrence & Homozygosity: Demonstrated to be >99% accurate in Fernandes, 201531
    • Structural Biology Analysis: Myriad's approach described in Kerr, 201632
    • Functional RNA Splice Site Analysis: Myriad developed the first research laboratory dedicated to RNA analysis, the approach of which is described in Warf 201533
  • Advanced Methods Unique to Myriad
    • M-CO: Myriad's unique mutation co-occurrence statistical model was developed and validated with >400,000 patients and demonstrated to be >99% accurate in Coffee, 201534
    • Pheno: Myriad's unique family history weighting tool developed and validated for BRCA 1/2, MLH1, MSH2, MSH6, ATM, CHEK2, PALB2, and BARD1. Demonstrated to be 99% accurate in multiple publications35-37
myVision is a lifetime commitment to patients, with review of variants and updated amended reports sent out to patients daily38
  • 60,000+ amended reports between 2006 and 2016
  • 2,868 variants reclassified between 2006 and 2016
  • 9% of these reclassifications impacted recommended medical management

Why is variant classification important?

Variant classification is a key component of germline testing, allowing patients to have an accurate answer when they receive a result and stay informed as new information leads to reclassification on a daily basis Tumor testing labs do not send amended reports or have variant classification programs, leading to a gap in patient care Myriad myRisk testing detects all mutation types with >99% accuracy, whereas tumor testing and other labs may not detect all mutations, including large rearrangements

Who else does variant classification?

Other labs may have variant classification programs, but interpretive accuracy can vary greatly among labs29

Myriad has a diverse team of experts involved in variant classification, with review occurring daily

Understanding Results

Myriad provides a comprehensive report and Medical Management Tool (MMT) for every patient who undergoes a myRisk test regardless of result. The MMT incorporates a comprehensive report of the genes tested and a summary of society guidelines to optimize your patient's medical management.

As variants are reclassified, you will receive amended reports automatically as a part of Myriad's lifetime commitment to you and your patients.

References

  1. Litton JK, et al. N Engl J Med. 2018; 379(8):753-763.
  2. Moore KN, et al. N Engl J Med. 2018; 379(26):2495-2505.
  3. Golan T, et al. N Engl J Med. 2019; 381(4):317-327.
  4. Referenced with permission from NCCN: NCCN® Invasive Breast Cancer Version 1.2018.
  5. Referenced with permission from NCCN: Ovarian Cancer. Version 2. 2019.
  6. Referenced with permission from NCCN: Pancreatic Adenocarcinoma. Version 2.2019.
  7. Ford D, et al. Lancet 1994; 343(8899):692-5
  8. Metcalfe KA, et al. Gynecol Oncol. 2005 Jan; 96(1):222-6
  9. Weissman et al. J Genet Couns. (2011). 20(1):5-19
  10. Nielsen M, Lynch H, Infante E, et al. MUTYH-Associated Polyposis. 2012 Oct 4 [Updated 2015 Sep 24]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2019
  11. Baglietto L, et al. J Natl Cancer Inst. 2010; 102(3):193-201.
  12. Begg CB, et al. J Natl Cancer Inst. 2005; 97(20):1507-15.
  13. Giardiello FM, Brensinger JD, Tersmette AC, Goodman SN, Petersen GM, Booker SV, et al. Very high risk of cancer in familial Peutz-Jeghers syndrome. Gastroenterology 2000; 119:1447-53. [PMID 11113065]
  14. Pharoah PD, et al. Gastroenterology. 2001; 121(6):1348-53.
  15. Tai YC, et al. J Natl Cancer Inst. 2007; 99(23):1811-4.
  16. American Cancer Society, 2019
  17. Foulkes, WD et al. N Engl J Med. 2008; 359:2143-2153.
  18. American Society of Breast Surgeons 2019 Consensus Guideline on Hereditary Genetic Testing for Patients With and Without Breast Cancer
  19. Walsh T., Casadei S., Lee M. K., et al. Mutations in 12 genes for inherited ovarian, fallopian tube, and peritoneal carcinoma identified by massively parallel sequencing. Proceedings of the National Academy of Sciences of the United States of America. 2011;108(44):18032-18037.
  20. NCCN Guidelines
  21. Lynch, H. T. Genetics and pancreatic cancer. Arch. Surg., 129: 266-268, 1994
  22. Nicolosi et al. Prevalence of Germline Variants in Prostate Cancer and Implications for Current Genetic Testing Guidelines JAMA Oncol 2019
  23. Johns LE, Houlston RS. A systematic review and meta-analysis of familial colorectal cancer risk. Am J Gastroenterol. 2001 Oct;96(10):2992-3003. Review. PubMed PMID: 11693338.
  24. Gayther SA, Pharoah PD. The inherited genetics of ovarian and endometrial cancer. Curr Opin Genet Dev. 2010;20(3):231-238. doi:10.1016/j.gde.2010.03.001
  25. Gradishar W, et al. The Oncologist 2017.
  26. Balmana J, et al. The Oncologist 2016.
  27. Eggington J, et al. Clinical Genetics 2013.
  28. Judkins T, et al. BMC Cancer 2014.
  29. Toland A, et al. Genomic Medicine 2018
  30. Esterling, L, et al. ASHG 2015.
  31. Fernandes P, et al. ACMG 2015.
  32. Kerr I, et al. International Symposium on HBOC 2016.
  33. Warf B, et al. International Symposium on HBOC 2016.
  34. Coffee B, et al. ACMG 2015.
  35. Pruss D, et al. Breast Cancer Research and Treatment 2013.
  36. Morris B, et al. BMC Genetics 2016.
  37. Bowles K, et al. ACMG 2016.
  38. Mersch J, et al. JAMA 2018.
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