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
Cécile 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.