"There probably are some people who are very high risk … who maybe shouldn't be so happy when they get a negative result," she said.Īt Fox Chase Cancer Center in Philadelphia, a couple of patients come in for confirmatory testing each month after learning they are positive for one of the BRCA mutations reported by 23andMe. However, Mangione is more uncertain about what patients do after getting negative DTC test results. Individuals with positive results indicating they're at high genetic risk for a serious illness like breast cancer may be more motivated to follow up with medical professionals and genetic counselors and get confirmatory testing. She and her UCLA colleagues are seeing patients who have gotten DTC genetic testing, some of whom are "very alarmed" by their results. "It's a little bit the Wild Wild West right now, because we really don't know the implications of a lot of these home test kits," said Carol Mangione, chief of general internal medicine and a primary care physician at the University of California, Los Angeles. In the meantime, for healthcare professionals on the ground it feels a bit chaotic.
SHOULD I GET MY HEALTH REPORT FROM 23ANDME PROFESSIONAL
"More equitable health care will come only if we can provide direct access - access without a medical professional barrier - in affordable ways," she wrote.
In response to a recent piece published by the New York Times editorial board highlighting some of the limitations of 23andMe's BRCA test, CEO Anne Wojcicki defended the company, highlighting the FDA's authorization of its tests and studies that show a high customer comprehension rate of concepts in reports, including negative results. 23andMe has said that it has no plans to provide genetic counseling at this time, which some industry observers believe is part of the company's plan to disrupt the healthcare system and force it to adapt to a future where unfettered consumer access to health-related information is the new normal. Some have called on 23andMe to incorporate genetic counseling into its services at a minimum. 23andMe's critics argue that as a loud proponent of empowering people with their genetic information, the company has a responsibility to help ensure its customers aren't missing opportunities to use their genetic information to prevent disease. Part of the problem is that there isn't an established framework for ensuring that customers of DTC genetic testing firms, who initiate testing on their own, are brought into the healthcare system when appropriate for follow-up care. But the FDA's scrutiny hasn't reassured healthcare providers, genetic counselors, and patient advocates who say they are encountering people who do not fully grasp the limitations of 23andMe's offerings. But recognizing people's increasing interest in mining their DNA for insights, the FDA gave 23andMe permission to market its reports directly to consumers (DTC), without a doctor's prescription, after evaluating the way it presents test results in reports and surveys showing consumers understand this information, among other things. These tests aren't intended to be used for medical decision making and aren't as comprehensive as clinical tests are. Earlier this year the company announced it would soon launch a new FDA-cleared report for two MUTYH variants associated with high risk of a colorectal cancer syndrome, and last week it unveiled a new report for familial hypercholesterolemia that gauges 24 variants in the LDLR and APOB genes. Last year, the agency authorized a test that gauges three BRCA1/2 variants that tend to show up in the Ashkenazi Jewish population and are associated with increased risk for breast, ovarian, and prostate cancers.Ģ3andMe now seems poised to introduce new health risk reports at a faster clip. In 2017, 23andMe received FDA authorization for the first crop of 10 genetic health risk tests.
Yet, the public health concerns that have trailed the company since its inception aren't going away. NEW YORK (GenomeWeb) – 23andMe is one of the most recognized brands in consumer genetics and the only company in the space to have submitted its health risk tests for US Food and Drug Administration scrutiny.
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