ANNOUNCING: COLARIS® and COLARIS AP® MYH Enhancements

February 6, 2013

RE: COLARIS® and COLARIS AP® MYH Enhancements

Myriad Genetic Laboratories, Inc. is pleased to announce enhancements to our COLARIS® and COLARIS AP® testing for Lynch syndrome and Polyposis syndromes. These important enhancements demonstrate our ongoing commitment to providing the most accurate and complete testing services possible for common hereditary cancer syndromes.

COLARIS currently provides full-sequencing and large rearrangement analysis of MLH1, MSH2, MSH6, PMS2 and large rearrangement analysis of EPCAM. COLARISAP currently provides full-sequencing and large rearrangement analysis of APC as well as a mutation panel for two common MYH mutations. Effective February 6, 2013, Myriad will launch COLARIS^PLUS and COLARIS AP^PLUS, which include full-sequencing and large rearrangement gene analysis of MYH for MYH-associated polyposis (MAP) syndrome. These enhancements will increase the rate of mutation detection among patients found to be at increased risk for Hereditary Colorectal Cancer caused by either Lynch(HNPCC) syndrome or adenomatous polyposis syndromes.

MAP is associated with increased colorectal cancer risk caused by mutations in the mutY homolog (MYH) gene. The MYH gene plays an important repair role in oxidative DNA damage which contributes to genomic instability and increased cancer risk if left unchecked.  Individuals with MAP have mutations in both copies of their MYH genes (inherited in an autosomal recessive manner with one mutation from each parent, often referred to as “biallelic MYH mutations”). Patients often have no family history of colorectal cancer or polyps in parents (although siblings may be affected).⁷ Recent population-based studies have found that MAP may account for up to 1% of all colorectal cancer, and up to 3% of early onset colorectal cancer.^1,2,3,4While polyposis is considered to be a characteristic feature of MAP, studies have found that a subset of patients present with colorectal cancer in the absence of recognizable polyposis.^1,2,5,6 As part of an ongoing Myriad clinical study to evaluate the prevalence of MYH mutations, Myriad will be offering this enhancement at no additional charge to COLARIS^PLUS and COLARIS AP^PLUS test orders received on or after February 6, 2013.

Myriad is committed to optimized patient care and has taken steps beyond other labs to ensure that comprehensive MYH testing is included for patients at risk for Lynch and Polyposis syndromes. Our mission is to ensure that we deliver an accurate, on-time result, with access to resources that will help enhance your patients’ care. Order a test kit and learn more here.

Please feel free to contact your Myriad sales representative or Patient Services Coordinator at (800) 469-7423.

Sincerely,

Richard Wenstrup, MD

Chief Medical Officer

Myriad Genetic Laboratories, Inc.

Benjamin Roa, Ph.D.

Vice President of Technology Development

Laboratory Director

Myriad Genetic Laboratories, Inc.

REFERENCES:

1. Al-Tassan Net al. Nature Genetics 2002;30:227-32.

2. Cleary SP et al. Gastroenterology 2009;136(4): 1251-60.

3. Farrington SM et al. Am J Hum Genet 2005; 77(1): 112-9.

4. Giraldez MD et al. Clin Cancer Res. 2010;16(22):5402-13.

5. Balaguer F et al. Clin Gastroenterol Hepatol 2007;5(3):379-87.

6.Jo WS et al. Clin Gastroenterol Hepatol 2005;3(10): 1022-8.

7.Fleischmann C et al. Int J Cancer. 2004;109(4):554-8.