As new ovarian cancer therapies and diagnostic tools come to the market, OCRA is working to make sure that patient safety is protected. New therapy approvals should consider the patient voice throughout the regulatory process and diagnostic tools must be tested to ensure clinical validity.
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OCRA believes that all diagnostic tests – regardless of where they are developed – should be independently verified to ensure safety and clinical validity, and we support regulatory reform to that end.
Diagnostic tests are critical tools in clinical decision-making, providing a wealth of information that is used by doctors and patients to make important decisions at every stage of care.
Currently, a diagnostic test produced by a manufacturer and sold to a laboratory must first obtain pre-market clearance or approval from the FDA to support the safety and effectiveness of the test. These tests are also subject to comprehensive quality system requirements from design through distribution, as well as post-market oversight that includes mandatory adverse event reporting and FDA’s recall authority. Labs that develop, manufacture, and use their own similar tests (laboratory developed tests or LDTs), however, are not under the regulatory authority of FDA, but rather Centers for Medicare and Medicaid Services (CMS), and as such, are not subject to the same rigorous standards to certify reliability, safety, and effectiveness as FDA-cleared diagnostic tests developed offsite by a manufacturer.
LDTs have proliferated the health care ecosystem in the last two decades, and are widely used interchangeably with FDA-approved or cleared diagnostics. Often patients, or even doctors, are unaware of the regulatory status of the test being used to make critical treatment decisions.
Evidence showing the harmful repercussions of unregulated LDTs has amassed, and several disease areas have been adversely impacted, including ovarian cancer. In January 2017, FDA issued a Discussion Paper on Laboratory Developed Tests that outlines an effective case for the need for regulation, and included these two examples:
- In 2008, OvaSure was introduced, marketed as an early detection test for ovarian cancer. The test was not independently verified to insure clinical validity. It was soon discovered that the test did not accurately predict ovarian cancer cases, leading otherwise healthy women to have their ovaries removed based on bad information.
- More recently Abcodia released the ROCA Test and marketed it directly to consumers as an effective “early detection” test for ovarian cancer. Prior to wide release, OCRA convened a group of experts over the course of two scientific meetings who produced a white paper published in American Family Physician, which concluded that the findings of the related studies did not demonstrate the necessary results needed to warrant screening the general public. Despite the challenge, Abcodia moved forward and expanded access to the test throughout the country. The company finally pulled the test only after FDA issued a safety alert to consumers.
Due to the incredible importance of diagnostic accuracy and patient safety, it is essential that LDTs are properly regulated. OCRA is working closely with Members of Congress and FDA to promote a regulatory mechanism to ensure that LDTs are independently tested to verify their clinical validity and safety.
We are also engaging in efforts to increase the availability of genetic testing, as this is an important factor both in precision treatment of ovarian cancer and prevention of the disease. In addition, we closely monitor any efforts that threaten the privacy of genetic data.
Genetic Testing for Precision Treatment and Risk Reduction/Prevention
Medical treatments have historically been designed as one-size-fits-all for the “average patient” – which is effective for some but not everyone. Precision medicine, however, shifts away from this paradigm and uses a tailored approach to treatment that takes into account individual variability in genes, environment, and lifestyle. Genetic testing plays a huge role in making decisions regarding the most effective course of treatment for an individual’s ovarian cancer.
For this reason, OCRA believes that in accordance with National Cancer Center Network (NCCN) guidelines, all women diagnosed with ovarian cancer should receive genetic testing and we support policies that lift barriers to these services.
In addition, genetic testing has created new opportunities in cancer prevention and risk management through screening of undiagnosed or asymptomatic patients who either have a family history of, or belong to groups known to carry a higher risk for, ovarian cancer. . Thus, we believe that requirements for insurance coverage of genetic counseling and testing are incomplete unless they also include provisions for the necessary and appropriate risk-reducing interventions in the event of positive results.
Learn more about inherited genetic mutations, such as BRCA, and how women may opt for risk-reducing interventions like prophylactic surgery and increased surveillance.
Protections Against Genetic Discrimination
OCRA supports the Genetic Information Nondiscrimination Act (GINA) and similar policy proposals that provide protections against discrimination on the basis of genetic information. GINA, passed in 2008, prohibits employers from using genetic information in hiring, firing and promotion decisions, as well as requesting their employees submit to genetic testing. GINA also bans health insurers from rejecting coverage or raising premiums for healthy individuals based on their genetic information.
Notably, GINA’s protections do not extend to life, disability and long-term care insurance, however several states have passed laws to bolster this. Federal laws that offer additional legal and privacy protections to patients include:
- The Privacy Act of 1974 allows for some privacy protection for medical records.
- The Americans with Disabilities Act (ADA) addresses similar issues regulating medical information about disabilities by protecting both privacy and discrimination (employment, public services and public accommodations; genetic illnesses are not specifically referenced, however).
- The Health Insurance Portability and Accountability Act, passed in 1996, upholds some restrictions on the use of genetic information in setting premiums and determining eligibility for benefits in health insurance.
- The Patient Protection and Affordable Care Act, passed in 2010, states that health insurance providers cannot deny coverage or set rates based upon any pre-existing medical condition.
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