Because of the role genetic testing now plays in the management of cancer, and in the identification of risk for the disease, physicians should make sure that patients know the limits of a key federal privacy law, Leonard Gomella, MD, said during a panel session at the virtual American Urological Association 2020 Annual Meeting.
A new set of recommendations on the use of genetic testing — published in June by the International Philadelphia Prostate Cancer Consensus Conference, which Gomella cochairs — strongly endorses the testing of all men with metastatic prostate cancer to aid with treatment decisions and to assess eligibility for clinical trials.
But it is important to understand that there are limits to the Genetic Information Nondiscrimination Act (GINA) of 2008, which was written to protect against discrimination in employment and medical insurance for people with known genetic risk factors for disease, said Gomella, who is chair of the Department of Urology at Thomas Jefferson University in Philadelphia.
“It may not necessarily protect the patient if they are looking for disability or long-term care insurance, a subtle but an important point,” he said.
GINA and a Patchwork of State Laws
To some degree, GINA builds on protections offered by the Americans With Disabilities Act (ADA) of 1990. But there are important distinctions, said Elizabeth Pendo, JD, a specialist in disability law, bioethics and the law, and health law and policy at St. Louis University in Missouri.
This is, in part, because GINA has a legislative history distinct from other disability laws. The ADA and other laws, such as the Rehabilitation Act of 1973, were built on histories that showed patterns and practices of discrimination.
The enactment of GINA, in contrast, stemmed largely from concerns that people would be reluctant to undergo genetic testing or to participate in research projects that involved the collection of DNA, Pendo said.
A person who appears, on genetic testing, to have a predisposition to a disease but does not show signs of it would have protection under GINA but not under the ADA, she told Medscape Medical News.
“They don’t have a disability as defined under that statute,” she explained. “To be protected under the Americans With Disabilities Act, you need to have a physical or mental impairment that substantially limits a major life activity or a history of an impairment or be regarded as having an impairment.”
Many states had laws on their books before GINA that addressed the potential for misuse of genetic information. New York law prohibits discrimination on the basis of “predisposing genetic characteristics” in the narrow context of hiring, retaining, and discharging interns, according to a recent report.
And a “handful” of states, including California, have laws that prohibit genetic discrimination in housing, lending, land use, and other contexts, the authors explain.
“In sum, the patchwork of state laws addressing [genetic discrimination] in various contexts spans the domains of life insurance, long-term care insurance, disability insurance, health insurance, employment, and housing, to name a few,” the team writes. “Unfortunately, there is a wide variation in coverage among states, and many of the laws lack adequate coverage, protections, or remedies.”
Congress could amend GINA to include protection against discrimination in the sale of life insurance or long-term care insurance, for example, although the issues around long-term care are more complex because of the financial demands, said Pendo. “Whether there is enough of a movement to motivate Congress to do that is a different question.”
Two new diagnostic tests were approved earlier this year: FoundationOne CDx (Foundation Medicine) for the identification of patients with metastatic castration-resistant prostate cancer (mCRPC) who carry HRR gene alterations; and BRACAnalysis CDx (Myriad Genetic Laboratories) for the identification of patients with mCRPC who carry germline BRCA1/2 alterations.
Urologists should become familiar with the common commercial genetic test panels for prostate cancer, such as those from Ambry Genetics, Fulgent Genetics, GeneDx, Invitae, Neo Genomics, and Strand Diagnostics products, said Gomella.
The makers of these tests can help urologists and their patients process and understand test findings. Some of these firms provide sheets for gathering family histories, which can be handy tools for busy practices, he said. And many of the companies help with various levels of telehealth genetic counseling for patients.
It’s not just about ordering the test. It’s about the implications of what it means.
“There is a lot to understand about genetic counseling,” he explained, noting that some genetic alterations can have implications for relatives of a patient. “It’s not just about ordering the test. It’s about the implications of what it means.”
During his presentation, Gomella highlighted recent advances in the management of prostate cancer that stem from an understanding of genetic triggers.
“In 2020, precision medicine took a big leap ahead in prostate cancer and genetic testing with the approval of the two new” Poly (ADP-ribose) polymerase (PARP) enzyme inhibitors, he reported.
On May 15, the US Food and Drug Administration (FDA) announced the accelerated approval of rucaparib (Rubraca, Clovis Oncology) for patients with deleterious BRCA mutation-associated mCRPC who have been treated with androgen-receptor-directed therapy and a taxane-based chemotherapy. The drug had previously been approved for ovarian cancer.
Then, on May 19, approval was announced for olaparib (Lynparza, AstraZeneca) for adults with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who progressed after treatment with enzalutamide (Xtandi, Pfizer/Astellas) or abiraterone (Zytiga, Janssen). The drug had previously been approved for breast, ovarian, and pancreatic cancers.
Gomella has participated in advisory boards for Clovis, AstraZeneca, and Strand Diagnostics.
American Urological Association (AUA) 2020 Annual Meeting. Presented June 27, 2020.