Monday, February 24, 2014

Genetic Testing Lab Position Statement


To show your support of this position statement, please send an e-mail with your intent, and affiliation to danielle.bonadies@yale.edu

Since the patents on the BRCA1 and BRCA2 genes (associated with hereditary breast and ovarian cancer) were overturned in mid-2013, the options for BRCA testing have exploded. Many laboratories are offering comprehensive, quality testing at ~50% of the previous cost. This competitive marketplace has many benefits to patients, providers and researchers, but we have also seen some laboratories beginning to use manipulative tactics to secure their profits in this volatile field. Genetic counseling centers have reported receiving pressure from clinicians to use specific laboratories for testing, learning that these clinicians are receiving financial incentives or hefty speaker's fees from these laboratories. The conflict of interest is clear. We have reports of other laboratories threatening to siphon-off referring clinicians if their laboratory isn’t used.

Below please find the full text on a “Genetic Testing Lab Position Statement” that pledges we, the ordering clinicians, will continue to make laboratory and testing choices based on what is in the best interest of our patients and will not be swayed by political, personal or financial gain.

This is also an opportune time for patient organizations, clinical organizations and insurers to show their support of laboratories that will fully share past, current and future data in open databases that serve research and patient care.

Please pass this on to your family, friends, colleagues, patients and contacts within your networks.


Genetic Testing Position Statement
Cancer Genetic Counseling Program Yale School of Medicine/Yale Cancer Center
New Haven, CT February 2014


With the emergence of new testing technologies and the 2013 Supreme Court decision banning gene patenting, the available cancer genetic testing options and the laboratories offering testing have expanded exponentially and are likely to continue to do so. As providers we have a responsibility to our patients to make the best decisions regarding which laboratory to use and which tests are most appropriate based on what is best for the patients. Our decisions will not be swayed by political, personal and/or financial gain.

Whenever possible (1), we will choose a laboratory based on these four criteria:


1. Quality: Is the test being offered accurate and comprehensive compared to what else is on the market?

2. Time: How long will the patient have to wait for his or her test results?

3. Cost: Will our patient’s insurance carrier cover this test at this laboratory?

4. Open Access: Has this facility pledged to Free The Data? Whenever possible we will choose laboratories that have pledged to make all of their past, present, and future gene data publicly available in order to allow this important information to be freely accessible to all clinicians and researchers, to further the advancement of medical knowledge and to best serve patient care. We will not support laboratories that hoard data.

To avoid any real or perceived conflicts of interest, we will not accept gifts (including trips, speaking stipends, stock options), funding, personal or financial support from testing laboratories. We pledge to update our laboratory choices over time as these choices evolve, choosing the best option for our patients and clinical research.

As clinicians, insurance plans, patient groups, and professional organizations nationwide begin to decide which laboratories to use in this quickly evolving marketplace, we ask that they join us in this pledge.

1. Laboratory choices must sometimes be based on insurance plan regulations, test availability, or the lab’s previous experience with a rare familial mutation.


 Genetic Testing Lab Position Statement.pdf -


Position Statement Signed By:


Clinicians:

Ellen T. Matloff, MS, CGC, Yale Cancer Genetic Counseling

Danielle C. Bonadies, MS, CGC Yale Cancer Genetic Counseling

Karina L. Brierley, MS, CGC, Yale Cancer Genetic Counseling

Rachel E. Barnett, MS CGC, Yale Cancer Genetic Counseling

Niki Lovick, MS CGC, Yale Cancer Genetic Counseling

Michelle Ernst, MS CGC, Yale Cancer Genetic Counseling

Jennifer Doherty, MS, CGC, Yale Cancer Genetic Counseling

Amanda Lamb, ScM, CGC, Maine Medical Center

Nisha Isaac, MS, CGC, University of Maryland St. Joseph Medical Center

Sayaka Hashimoto, MS, LGC, Nationwide Children's Hospital and Ohio State University

Kristin DePrince Mattie, MS, MD Anderson Cancer Center at Cooper

Cathleen McCann, MS, CGC, Sarasota Memorial Healthcare System

Paul B. Dorsey, MS, Legacy Genetic Services

Catie Beattie, MS, CGC, Casey Eye Institute

Peggy Cottrell, MS, CGC, Regional Cancer Center

Jessica Adsit, MS, CGC, Legacy Center for Maternal Fetal Medicine

Amie M. Blanco, MS, LCGC, UCSF Cancer Risk Program

Carrie Fagerstrom, MS, CGC, Randall Children's Hospital at Legacy Emanuel

Melanie Hardy, MS, CGC, Henrico Doctors’ Hospital

Allen E. Bale, MD, DNA Diagnostic Lab, Yale University

Robert Pilarski, MS, LGC; MSW, LSW, Ohio State University Cancer Genetics Program

Christina Dupre, MS, CGC, New England Ob/Gyn Associates

Lauren Ryan, MS, LCGC, UCSF Cancer Risk Program

Meagan Farmer, MS, CGC, University of Alabama at Birmingham

Robert Cook-Deegan, MD, Institute for Genome Sciences & Policy and Sanford School of Public Policy at Duke University

Carol Guthrie, MD Spokane Breast Center, Columbia Medical Associates

James P. Evans MD, PhD, Bryson Distinguished Professor of Genetics & Medicine, Editor-in-Chief; Genetics in Medicine, University of North Carolina at Chapel Hill

Robert Nussbaum, MD, Division of Medical Genetics, University of California, San Francisco

Erin Ash, MS, CGC, Bennett Cancer Center of Stamford Hospital

Cristina Ruiz, MS, CGC, Advocate Center for Breast Care,Oak Lawn, IL

Kelli Mayfarth, MS, CGC Health-Quest Hospital System, New York

Tricia Z. Page, MS, CGC, JScreen at Emory University

Kory Jasperson, MS CGC, Huntsman Cancer Institute

C├ęcile Skrzynia, MS, CGC,Cancer and Adult Genetic Counseling, UNC Chapel Hill

Kim Brussow, MS, LCGC,Good Samaritan Hospital

Jessica Chowns, MS, CGC, Parkview Health

Melissa Dempsey, MS,Parkview Health

Kathy Christiansen, RN, BSN, OCN,Cancer Prevention and Hereditary Cancer Risk Program, Methodist Estabrook Cancer Center

Marjan Champine, MS, LCGC, Huntsman Cancer Institute

Shawnia Ryan, MS, CGC, Providence Genetics Clinic

Lindsay Conant, MS, LCGC,Oregon Health Science University

Shelly Levin, MS, LCGC, Kaiser Permanente Medical Group

Amy K Krie,MD, Medical Oncologist, Clinical Director Avera Breast Program

Brittany Burnett, MS, LCGC, Sharp Healthcare, San Diego, CA


Community Members and Advocacy Groups:

Genetic Alliance

Kirsten Dooley, Yale Cancer Genetic Counseling

Lisa M Guzzardi, BRCA Advanced, Facebook Group

Marly Canuck Wietzke, Vancouver, BC, Canada

Nicki Boscia Durlester, Founder, Beyond the Pink Moon, Facebook Group

Pamela Morris Watt, CT

Tracy Dunbrook, CT

Cathy Corman, MA

Katie Behr, CT

Andrea Downing, Activist, Patient Advocate

Amy Byer Shainman, The BRCA Responder, BRCA Health Advocate, Co-Administrator of The BRCA Sisterhood on Facebook

Victoria Costello, Genetic Counseling Graduate Student, Sarah Lawrence

Leslie Kellman, NY

Marlene Kuma Gutierrez, CA

Rochelle Bernold, CT

Emily Kelley, Community Manager, Young Previvors Facebook Page

Teri Smieja, Co-author of Letters to Doctors, The BRCA/HBOC edition, Co-creator BRCA Sisterhood Facebook Group.

RaeAnn Kragenbring, Genetic Counseling Graduate Student, Sarah Lawrence

Mary Carpenter

Katherine Lambertson, Fellow, Genetic Alliance

Robin Baslaw, CT

Kate Berges, CT

Jessica DiGiovanna, Genetic Counselling Graduate Student, Mount Sinai

Peter Grudberg, CT

Terry Stoller, CT

Jill Holdren

Joanna Rudnick, Independent Documentary Filmmaker