Friday, July 22, 2011

An Open Letter to Myriad Genetics

Dear Patients and Providers,

As many of you know, Myriad Genetic Laboratories holds the exclusive patent for testing for mutations within the BRCA1 and BRCA2 genes. Among individuals at "high risk", their "Comprehensive" BRCA testing currently detects ~90% of all possible mutations (genetic changes). Among individuals at "high risk", the other ~10% of mutations (called large rearrangements) are missed with this technique alone. For most patients, testing for large rearrangements is a separate $700 test (called BART) that is often not covered by insurance.

Recent data released by Myriad suggests that these large rearrangement BRCA mutations are over-represented and account for a larger percentage of mutations than previously thought in some populations including Hispanics/Latinos. In addition, data from other groups suggests Myriad's "high risk" criteria do not accurately predict which patients are likely to carry a BRCA rearrangement mutation. Therefore, we are appealing to Myriad to include BART analysis in their standard BRACAnalysis for all patients, so that it will truly be the Comprehensive testing that they advertise.

Below please find the full text of an open letter to Myriad Genetics Laboratories re: BART testing. If you would like to sign on to this letter, please send a separate e-mail with your intent, and patient/provider affiliation to karina.brierley@yale.edu.

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July 22, 2011

Richard Wenstrup, MD

Chief Medical Officer

Myriad Genetic Laboratories

Dear Dr. Wenstrup,

Thank you for your data of July 11, 2011 demonstrating that a significant proportion of BRCA1 and BRCA2 mutations are not detected by your $3340 Comprehensive BRACAnalysis, but are only detected by ordering the additional $700 BART Analysis of BRCA1 and BRCA2.1 Your data demonstrate that the proportion of mutations detected only by BART is higher in patients of Latin American/Hispanic ancestry.1 This Hispanic population is one of the most rapidly growing ethnic groups in the United States and is disproportionately uninsured, underinsured, and at or below poverty levels.2,3 Therefore, this population is less likely to be able to access and afford the necessary, expensive, additional BART testing.

Dr. Wenstrup, we, the undersigned are asking Myriad to include BART analysis as part of your Comprehensive BRACAnalysis, effective immediately. As you know, most insurance companies do not cover the extra BART Analysis and most patients do not have this important testing. This means we are missing BRCA mutations in many patients, which is costing lives. Most patients cannot afford $700 out of pocket. Recent data indicate that your high-risk criteria do not predict which patients are carrying a BART mutation.4 All patients having Comprehensive BRCA testing also need BART analysis.

We note that Myriad’s 2011 Third Quarter Revenue report indicates that your company has enjoyed its best revenue and operating income results for any period in your history, with a 3rd quarter revenue of $102.4 million (13% increase compared to last year).5 We implore you to reinvest some of your earnings into incorporating BART analysis into your standard BRACAnalysis, so that it will truly be the Comprehensive testing you advertise.

Sincerely,

Ellen T. Matloff, MS, CGC

Rachel E. Barnett, MS, CGC

Danielle C. Bonadies, MS, CGC

Karina L. Brierley, MS, CGC

Pia Banerji Summerour, M.S., CGC

Andrea Schwerdt, RN, BSN, OCN

Jayne A. Murphy, M.S., CGC

Gina Cowing, MS

Sara Goldstein, MS, CGC

Danielle Piippo, MMS, PA-C

Tina Bartell, MS

Sumedha Ghate, MS

Andrea Paal, M.S.

Maureen Flynn, MS, LGC, MPH

Nancy Cohen, MS, CGC

Kristin Kalla, M.S., CGC

Dana Kostiner Simpson, MD

Brittany Burnett, MS, CGC

Sharanya Kumaravel, MS

Erin Ash, MS, CGC

Janey Youngblom, Ph.D., M.S.

Meghan Wayne, MS, CGC

Anna Newlin, MS, CGC

Susan Mecsas-Faxon, MS, CGC

Elena Strait, MS, CGC

Jessica Heinzmann, M.S.

Katherine S. Hunt, MS, CGC

Amy Thomas, MS

Lance Grau, MS, CGC

Mohamed Khalifa, MD

Catherine Ward-Melver, MD

Cheryl Cina, MS, CGC

Jennifer Stein, MS, CGC

Rebecca Yee, MS, CGC

Shannon Morrill-Cornelius, MS, CGC

Anneliese Gonzalez, MD

Michael D. Stone, MD

Niki Armstrong, MS, CGC

Shanna Gustafson, MS, MPH, CGC

Kelly Jo Hamman, MS, CGC

Chelsy R. Jungbluth, MS, CGC

Luba Djurdjinovic, MS

Erin Houghton, MS, CGC

Lindsey Morse, MS, CGC

Alissa Bovee, ScM, CGC

Murray L. Nusbaum, MD

Gayun Chan-Smutko, MS, CGC

Kara Bui, MS, CGC

William A. Fintel, M.D.

Robin King, MS, CGC

Josephine Wagner Costalas, MS

Kerry Kingham, MS, CGC

Saun Floyd, MS, CGC

Whitney Neufeld-Kaiser, MS, CGC

Carrie Koval, MS

Bridgette Aufmuth, MS, CGC

Stacey Miller, MS, CGC

Judith A. Durcan, MS, CGC

Erin Carney, MS, CGC

Kathy Morris, MSSW, LCGC

Dawn Lee, MS

Emily Smith, MS, CGC

Melanie S. Moshier, MS

Jennifer L. Czerwinski, MS, CGC

Stephanie Kozachek, MS, CGC

Kory Jasperson, MS, CGC

Jessica Lipschutz, M.S., C.G.C.

Cristi Radford, MS, CGC

Jessica Long, MS, CGC

Taya J. Fallen, MS, CGC

Carol Brudenell, MSN, RN, AOCN, CCRP

Sherry C. Grumet, MA, MS, CGC

Laura Colello, MS, CGC

Larry R. Glazerman, MD, MBA

Valerie Loik Ramey, MS, CGC

Mollie Lyman Hutton, MS, CGC

Debbie Pencarinha, MS, CGC

Cristina Ruiz, MS, CGC

Robin C. Schwartz, M.S., C.G.C.

Susan Donlon, MS, CGC

Heather L. Shappell M.S., CGC

Heidi Beaver, MPH, CGC

Christine Laronga, MD, FACS

Christina Bittner, MS, CGC

Linda Robinson MS, CGC

Janice Berliner, MS, CGC

Michelle Gilats, M.S.

Christine Rogness, MD, FACS

Lauren Bowling, MS

Christopher E. Mason, Ph.D.

Laura Esserman MD MBA

Julie S. Mak, MS, MSc, CGC

Christine Kobelka, M.Sc., CGC, CCGC

Nicola Stewart, MS, CGC

Amie Blanco, MS, CGC

Kate Loranger, MS, CGC

Melanie Baxter, ScM, CGC

Margo Thelander, MS, CGC

LaDonna Immken, MD

Gayle Simpson Patel, MS, CGC

Katherine Schneider, MPH, LGC

Emily Brown, MS, LGC

Elaine Hiller, MS, LGC

Shelley McCormick, MS, LGC

Irene Rainville, MS, PhD, LGC

Claire Healey, MS, LGC

Anu Chittenden, MS, LGC

Monica Dandapani, MS, LGC

Judy Garber, MD, MPH

Gemma Chandratillake, MS, MPhil, PhD

Janice Rinsky, M.S.

Sarah Jane Noblin, MS, CGC

Andrea E. Harbison, MS, CGC

Justin W. Leighton, MS

Elsa Reich, MS, CGC

Cathy M. Sullivan, MS, CGC

Bobbi McGivern, MS, CGC

Kristin DePrince Mattie, M.S.

Gillian W. Hooker PhD, ScM, CGC

Nadine Dumas, M.Sc., CCGC (CGAC)

Rachel Westman, MS

Masayo Niwa-Habibi, MS

Pat Himes, MS, CGC

Niecee Singer Schonberger, MS, CGC

Carrie Prochniak, MS

Sivya Twersky, MS, GGC

Lindsey Byrne, MS, CGC

Nichole Morman, MS, CGC

Seth Marcus, MS, LCGC

Kiana Siefkas, MS, CGC

Heather Hampel, MS, CGC

Jennifer Scalia Wilbur, MS, CGC

Sidra Shapiro Boshes, MS, CGC

Fiona M. Field, MS, CGC

C├ęcile Skrzynia, MS, CGC

Jilliane Sotelo, MS, LCGC

MaryAnn W. Campion, MS, CGC

Janice O'Connell, MS, CGC

Jennifer Burton, MS, CGC

Shawnia Ryan, MS, CGC

Angela Musial Fay, MS, CGC

Kim Horton RN, MS, CGC

Lindsay Dohany, MS, CGC

Kathleen D. Valverde, MS, CGC

Peggy Cottrell, MS, CGC

Marcia Jodah, MS, CGC

Nicole Mattila, MS, CGC

Tuya Pal, MD, FABMG

Karen Brown, MS, CGC

Maegan E. Roberts, MS, CGC

Jennifer Brzosowicz, MS, CGC

Leslie Aptekar, MS CGC

Camila Shanahan, MS, CGC

Jeanne Homer, MS

Robert Pilarski, MS, CGC, MSW, LSW

Susie Ball, MS, CGC

Alexandria M. Yonker, MS, CGC

Marvin Miller, MD

Rachel Nusbaum, MS, CGC

Michelle Lyons, MS, CGC

Diana C. Darcy, M.S., C.G.C.

Cecelia A. Bellcross, PhD, MS, CGC

Faith Callif-Daley, MS, CGC

Eric Hanson MD, MPH

Diana Moglia, MS, CGC

Melissa Gilstrap, MS, CGC

Colleen Tsikerdanos, M.S., C.G.C.

Erica Ramos, MS, CGC

Molly A. Brewer, DVM, MD, MS

Kristen Dieter, MS, CGC

Sara Svendsen, MS, LCGC

Elena Infante, MS

Thea A. Johnson, MS

Rebecca A. Madore, M.S., CGC

Karen S. Metzler, MS, CGC

Erica Blouch, MS

Beth Souders, MS, CGC

Scott T. Michalski, MS, LGC

Lisa Blazejewski, MS, CGC

Jamie C. Fong, MS, CGC

Amy Crunk, MS, CGC

Zipora Eckstein MS

Thereasa A. Rich, MS, CGC

Lori Ballinger, MS, CGC

Audrey Linn Schroeder, MS, CGC

Amanda Lamb, MS

Megan E. McKenna (Hooper), M.S., C.G.C.

Erin Dola, MS, CGC

Sarah Keilman, MS, CGC

Jess Cary, MS, RN, CGC

Christina A. Seelaus, MS, MA, CGC

William Foulkes, MD

Kasia J. Bloch, MS, CGC

Nisha Isaac, M.S., CGC

Teresa M. Blake, MS, CGC, LGC

Laura M. Tripi, MS, CGC

Sara Pirzadeh-Miller, M.S., CGC

Erin H. Steed, MS, CGC

Kristen Vogel, MS, CGC

Martha Thomas, MS, CGC

Kelli Swan, MS, CGC

Denise Marty, MS, CGC

Whitney L. Ducaine, MGC, CGC

Damini Desai, MS, CGC

Maureen May, MS

Scott M. Weissman, MS, LGC

Kami Wolfe Schneider, MS, CGC

Ronald L. Bauer, M.D., FACS

Andrea M. Bauer, MSN, NP-C, ANP

Additional signatures as of August 1, 2011

Donna D. Walgenbach, MS

Toni I. Pollin, MS, PhD, CGC

Heather Sellers, MS

Andrea Forman, MS, CGC

Cathy McCann, MS, CGC

Constance Gibb, MS, CGC

Matt Mealiffe, MD

Vinaya Murthy, MPH, MS, CGC

Shelly Galasinski, MS, CGC

Darnelle L. Dorsainville, MS, CGC

Shenela Lakhani, B.Sc., M.Sc.

Wendy Chung, MD PhD

Erin Hofstatter, MD

Nadine Tung, MD

Donna Russo, MS

Kristen Shannon, MS, CGC

Stephanie Diaz, MS, CGC

Catherine A. Corman

Michelle L. Morgan

Mary-Ann Sagnella

Alison Tainter

Leslie Phillip-Kellman

Candy Goldstein

Terry Stoller

Pamela Morris Watt

References:

1. Myriad Genetic Laboratories. BRCA1 and BRCA2 Prevalence Tables for Mutations Detected by Sequencing, the 5-site Rearrangement Panel (LRP) and the BRACAnalysis® Large Rearrangement Test (BART™) in High Risk Patients. Available at: http://www.myriad.com/lib/brac/BART-table-faq.pdf . Retrieved July 14, 2011.

2. U.S. Department of Health and Human Services: Office of the Assistant Secretary for Planning and Evaluation. Overview of the Uninsured in the United States: An analysis of the 2005 Current Population Survey Available at: http://aspe.hhs.gov/health/reports/05/uninsured-cps/index.htm#race . Retrieved July 14, 2011.

3. Lloyd Runser, Sabrina Eagan and Danielle Olds. The Uninsured and Underinsured. Available at: http://www.case.edu/med/epidbio/mphp439/Safety_Nets.htm . Retrieved July 14, 2011.

4. Shannon KM, Rodgers LH, Chan-Smutko G, Patel D, Gabree M, Ryan PD. Which Individuals Undergoing BRCAnalysis Need BART Testing? Cancer Genetics (in press)

5. Myriad Genetic Laboratories. Myriad Genetics Reports Fiscal 2011 Third Quarter Results. Available at: http://investor.myriad.com/releasedetail.cfm?releaseid=574140 . Retrieved July 14, 2011.