Abstract
In December 2014, the FDA approved olaparib, a poly(ADP-ribose) polymerase inhibitor (PARPi) for ovarian cancer patients who have failed three or more lines of chemotherapy and have a germline BRCA1/2 mutation identified through a companion diagnostic test (BRACAnalysis CDx™ (CDx™)) offered exclusively by Myriad Genetic Laboratories. This study explored the impact of PARPi/CDx™ on genetic counselors’ (GCs) counseling and testing practices. One hundred twenty three GCs responded to an online survey regarding pre- and post-FDA approval referral patterns, testing strategies/influences, and anecdotal experiences with insurance coverage of PARPi for BRCA1/2 positive patients through a non-CDx™ platform. Following PARPi approval, 40% of respondents reported an increase in overall referrals of ovarian cancer patients and 20% had an increase in post-test counseling only referrals. The majority (61.9%) of respondents reported no change in genetic testing strategy, and there was no change in factors influencing choice of testing laboratory. Nearly all (98.1%) respondents who had experience with insurance covering PARPi indicated approval with mutations identified via non-CDx™ testing. Respondents indicated an increase in referral volume following FDA approval of PARPi/CDx™, but did not report changes in testing practices. Respondents were not aware of PARPi insurance coverage denial in the absence of CDx™.
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Acknowledgements
This study would not have been possible without the expertise and dedication from many individuals. First and foremost, I would like to thank my thesis advisors, Kristen Vogel Postula and Scott Weissman, for their invaluable guidance, encouragement, and support throughout the study. Secondly, I am grateful to my thesis committee members, Shelly Weiss, Carmen Williams, and Mario Pineda, for their suggestions and direction in this process. I am also thankful for the statistics help from Suzanne O’Neill. Thank you to the Northwestern University Graduate Program in Genetic Counseling for supporting this project financially. Finally, thank you to the genetic counselors who took time to participant in the survey.
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Funding
This study was funded by the Graduate Program in Genetic Counseling at Northwestern University.
Conflict of Interest
Kathryn M. Buchtel, M.S. currently is employed by Myriad Genetic Laboratories, however, this employment began after the completion of this study. She also declares receiving honoraria from Bright Pink for speaking to primary care providers about breast and ovarian cancer risk assessment. Kristen J. Vogel Postula, M.S., and Scott M. Weissman, M.S., were employed by GeneDx at the time of the study completion. Shelly Weiss, M.S., was employed by Myriad Genetic Laboratories at the time of the study completion. Carmen Williams, M.S., and Mario Pineda, M.D./Ph.D declare that they have no conflict of interest.
Human Studies and Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all individual participants included in the study.
Animal Studies
No animal studies were carried out by the authors for this article.
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Buchtel, K.M., Vogel Postula, K.J., Weiss, S. et al. FDA Approval of PARP Inhibitors and the Impact on Genetic Counseling and Genetic Testing Practices. J Genet Counsel 27, 131–139 (2018). https://doi.org/10.1007/s10897-017-0130-7
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DOI: https://doi.org/10.1007/s10897-017-0130-7