A revolutionary test is transforming dementia care. Days after a simple blood test, a person with dementia can learn whether they have Alzheimer\u2019s disease. At least six companies sell these tests direct-to-consumer; no doctor\u2019s appointment is needed. For a few hundred dollars, an online shopper can order an at-home Alzheimer\u2019s biomarker test.<\/p>\n
Is Alzheimer\u2019s ready for \u201cdirect-to-consumer\u201d testing like COVID and HIV? Our answer is no \u2014 not until problems of accuracy, privacy, and access to follow-up care are addressed.<\/p>\n
Our concerns begin with test accuracy. The FDA guidance<\/a> for Lumipulse, the first blood test the FDA approved to diagnose Alzheimer\u2019s, emphasizes it should only be prescribed in settings such as a specialty clinic to a patient already showing signs of cognitive decline. This requirement lets a clinician decide whether this test is right for a patient. It also assures a patient that a positive test is truly positive, meaning the person has Alzheimer\u2019s disease. <\/p>\n Unlike medications that require a doctor\u2019s prescription, diagnostic tests can be sold without FDA approval, and other blood tests similar to Lumipulse\u2019s are available online. This means a person can obtain a test without any guidance from a clinician. <\/p>\n This presents a problem. In the general population, such as the vast number of people who might want at-home testing, the likelihood of Alzheimer\u2019s is much lower. So a large number of test results will be \u201cfalse positives.\u201d This means, many people whose result is \u201cpositive\u201d don\u2019t actually have the disease, and will require stressful and costly follow-up testing. <\/p>\n \u00bb READ MORE: How to get help if you are struggling with Alzheimer’s disease<\/a><\/p>\n The blood test results also are often not conclusive. The test has three possible results \u2014 positive, negative, and \u201cindeterminate.\u201d Up to 20% of people with cognitive impairment tested in a specialty setting will have an indeterminate result and will need more Alzheimer\u2019s biomarker tests.<\/p>\n Understandably, a person who feels their memory and cognitive skills are slipping will want to know if Alzheimer\u2019s is the cause. But the high error rate and chance of an indeterminate result are reasons not to take an at-home biomarker test but, instead, to see a doctor. <\/p>\n We\u2019re also worried that companies\u2019 marketing language is vague. We\u2019re dementia specialists, and we struggle to understand what they\u2019re selling. <\/p>\n Take the blood test to measure ptau217,<\/a> a protein and key biomarker of the disease. Versions of this test are now marketed by several companies, and are supposed to measure Alzheimer\u2019s pathology. Yet one company\u2019s online description of the test avoids the word Alzheimer\u2019s. Instead, they emphasize \u201ccognitive decline\u201d while marketing the test as an entr\u00e9e to subscription-paid access to unproven treatments. Testing marketers claim to offer \u201cscience-backed\u201d action to prevent symptoms, but their promises are not backed by medical evidence.<\/p>\n Another firm amplifies ambiguity when they offer tests such as neurofilament light chain, which measures another protein biomarker. Limited data explain the clinical value of these tests, particularly when measured in the general public.<\/p>\n All this vague language seems likely to cause the reader to lose focus on a critical question never raised in the test marketing materials: Are you sure you want to learn about a diagnosis of Alzheimer\u2019s?<\/p>\n A positive test result could put a person in legal, financial, and social jeopardy. Laws<\/a> protect a person with HIV from discrimination, but no such protections exist for a person who is cognitively unimpaired and has a positive Alzheimer\u2019s biomarker test. <\/p>\n Genetic nondiscrimination laws<\/a> protect persons at genetic risk of a disease. These laws don\u2019t apply to persons with a biomarker risk of disease. The websites promoting these tests also don\u2019t discuss how Alzheimer\u2019s and dementia discrimination come in many forms, such as loss of a job, exclusion from a continuing care residence, and friends distancing themselves.<\/p>\n Given these risks, the ethical use of Alzheimer\u2019s biomarker tests requires education and pretest counseling. This was the practice in the early years of genetic and HIV testing, and it\u2019s a practice that we and our colleagues have developed<\/a> for research studies that use these Alzheimer\u2019s tests. <\/p>\n Unfortunately, home test providers\u2019 marketing materials don\u2019t promote these messages. Instead, they feature easy access and the value of learning results.<\/p>\n Even if the tests were accurate in the general population, the language explaining them were clear, and pretest education was provided, users should be prepared for a positive test to set them on a difficult journey in an unprepared U.S. healthcare system.<\/p>\n The nation already faces a shortage of physicians and other providers capable of caring for adults living with dementia. Even fewer are trained to use the new Alzheimer\u2019s biomarker tests. Widespread home testing could lead to scores of people taking Alzheimer\u2019s results to their physicians with questions, with few providers able to handle those interactions. <\/p>\n For now, we think the industry of home Alzheimer\u2019s testing is an innovation too far, until these challenges are addressed. Here\u2019s how we would move forward:<\/p>\n America needs to build its care infrastructure. This will require new laws with nondiscrimination protections, ensuring the rights of cognitively unimpaired people who are biomarker positive, especially those still working. The millions of older adults with dementia and mild cognitive impairment (MCI), and the millions more who will eventually develop these conditions, need greater access to care.<\/p>\n Telemedicine, now widespread after the COVID pandemic, offers great promise to access care, but we need the government to provide additional funding through the Medicare program\u2019s support for graduate medical education to train more neurologists, geriatricians, and psychiatrists.<\/p>\n Drugs that delay the onset of the symptoms of the disease in people who are Alzheimer\u2019s biomarker positive and without symptoms will be a powerful driver of change. They are not yet available in clinical practice. Alzheimer\u2019s treatments now prescribed to people with dementia and MCI are being tested for this revolutionary use. These studies will show whether a treatment is effective at delaying the onset of dementia. This will help to validate the diagnostic value of a positive blood test. <\/p>\n This is the work needed to ensure that learning your Alzheimer\u2019s risk from an at-home test isn\u2019t so risky.<\/p>\n Joshua Grill, PhD, directs the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, and Jason Karlawish, MD, is a senior fellow at the Leonard Davis Institute of Health Economics and co-director of the Penn Memory Center at the University of Pennsylvania<\/a>. The authors are among the developers of processes and procedures to effectively use Alzheimer\u2019s biomarker results for patients and research participants.<\/p>\n","protected":false},"excerpt":{"rendered":"A revolutionary test is transforming dementia care. 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