Today, I published an article in the Philadelphia Inquirer with my colleague Jason Karlawish, MD, of the University of Pennsylvania about blood tests for Alzheimer’s disease.
Blood tests for Alzheimer’s disease represent remarkable and rapid progress and will revolutionize care for people with cognitive impairment and dementia. They will also pave the way to prevention—increasing accessibility to sensitive biological tests of brain health and disease.
But the tremendous advances in science have also led to some business opportunities that concern us. We were able to locate 6 companies on the Internet that are offering blood tests directly to consumers; that is, without involvement of a clinician provider.
We are whole-hearted proponents of new sensitive blood tests for use in the clinical assessment of patients with memory and other cognitive problems. They are a valuable step and may clearly rule out Alzheimer’s disease in some people and be a strong indication of the presence of Alzheimer’s disease in others. For a meaningful percentage of patients (~15%), additional testing – like a PET scan or lumbar puncture — may be needed to arrive at a confident diagnosis.
Blood tests are also hugely valuable to research. They are much cheaper and less burdensome than PET scans or cerebrospinal fluid (CSF) assays, but give similar (though, importantly, not exactly interchangeable) information. They can also be used to rule out people who are unlikely to qualify for prevention trials because the likelihood of biological eligibility for trials is quite low.
But companies are now marketing the opportunity to “learn your Alzheimer’s risk” or “learn if you have Alzheimer’s 10 to 20 years before dementia.” We have serious reservations.
The companies are anything but transparent. In most cases, we don’t know what platforms, assays, or thresholds they are using. Some seem to be using tests for which the data are far less convincing. And most troubling to us, some suggest that half of dementia cases can be prevented and offer subscription services to untested, unproven therapies or therapeutic regimens that no doubt come at substantial costs to consumers.
An unfortunate stigma still exists for Alzheimer’s disease. There are no protections for people with a diagnosis or with a biomarker label of disease from discrimination that could occur in the workplace, in healthcare or insurance, or even in daily life.
Direct-to-consumer Alzheimer’s blood testing is a bridge too far and, as of now, is unregulated and could put consumers at risk. Regulation is needed and consumers must be made aware of the personal, financial, and legal risks that may accompany the label of Alzheimer’s disease.
