With FDA clearance for Roche\u2019s new blood test, primary care doctors have an efficient new tool to screen for Alzheimer\u2019s before sending patients to specialists. \n<\/p>\n
For millions of people experiencing memory issues, getting an Alzheimer\u2019s diagnosis can involve long waitlists and invasive procedures. Blood tests<\/a> are emerging as a faster first step, helping doctors identify who may need further testing like brain scans or spinal fluid analysis.<\/p>\n The first FDA-cleared blood test for Alzheimer\u2019s<\/a>, from Fujirebio, is already used by specialists to help confirm a diagnosis. Now there\u2019s a second option. On Oct. 13, Roche\u2019s Elecsys pTau181 test \u2014 developed with Eli Lilly \u2014 received FDA clearance<\/a>.Roche\u2019s new test is designed for primary care doctors who are evaluating cognitive symptoms in patients 55 and older. Rather than confirming Alzheimer\u2019s, the Elecsys pTau181 test, developed in collaboration with Eli Lilly, helps primary care doctors rule out Alzheimer\u2019s as a possible cause.\u00a0<\/p>\n \u201cThis will be another test in the toolkit to help understand the cause of cognitive decline,\u201d Laura Parnas<\/a>, director of medical and scientific affairs at Roche Diagnostics, told Being Patient.\u00a0<\/p>\n How well does the test work?<\/p>\n In a 312-person study, Elecsys pTau181 correctly ruled out the presence of beta-amyloid plaques \u2014 the key hallmark of Alzheimer\u2019s in the brain that\u2019s required for diagnosis \u2014 97.9 percent of the time. The details and data from the study aren\u2019t yet published.\u00a0<\/p>\n Some blood tests don\u2019t work as well<\/a> in Black and Hispanic Americans, groups who are at the highest risk of the disease. But since Roche\u2019s study included an ethnically representative sample, Parnas said it would be accurate regardless of race.\u00a0<\/p>\n What do the test results mean?<\/p>\n Roche\u2019s blood test could help doctors determine whether their patients are at high risk.\u00a0<\/p>\n A positive result means that Alzheimer\u2019s can\u2019t be ruled out as a potential cause of cognitive decline. People who test positive might be referred to a specialist or memory clinic for cerebrospinal fluid, brain imaging, or blood biomarker tests to confirm a diagnosis. After the diagnosis, people in the earliest stages of the disease might consider trying anti-amyloid drugs like Leqembi or Kisunla<\/a>, or joining a clinical trial.<\/p>\n A negative result usually means that the cognitive symptoms aren\u2019t caused by Alzheimer\u2019s. In that case, clinicians might take another look at other possible causes like sleep apnea, vitamin or hormone deficiencies, or thyroid dysfunction.\u00a0<\/p>\n For some high-risk patients, including those over 80 who have memory problems resembling Alzheimer\u2019s, Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, told Being Patient that \u201cthe clinician should still consider additional testing\u201d to make sure it isn\u2019t a false negative.\u00a0<\/p>\n By helping primary care doctors screen their patients, it could ease the burden on specialty memory clinics, which Schindler said often have 6- to twelve-month waitlists.<\/p>\n When will the test be available, and how much will it cost?<\/p>\n Roche plans to sell the test in 2026 through clinical laboratories. However, the company isn\u2019t sure yet how much the test will cost or whether it will be covered by Medicare or private insurers.<\/p>\n Why is FDA clearance important?<\/p>\n