Article
What was cleared
Roche announced the clearance on Aug. 24. The test, developed with Eli Lilly, measures a single blood biomarker and reports whether a patient has a positive, intermediate or negative likelihood of amyloid pathology linked to Alzheimer’s disease. It is intended for adults 55 and older with signs or symptoms of cognitive decline, in either primary or specialty care, using the same cutoffs in both settings.
The company says results showed high agreement with amyloid PET imaging. The test is not meant to stand alone, and it is not established for predicting dementia or monitoring therapy. It runs on Roche’s cobas analyzers, of which more than 4,500 are installed in U.S. laboratories, so many hospital and reference labs could offer it without new equipment. Roche cites estimates that about three in four people living with dementia have no diagnosis.
Why operations leaders should care
A blood draw ordered by a primary care clinician is far easier to obtain than a PET scan or lumbar puncture. That lowers the barrier to evaluation, which is good for patients, but it also shifts where the bottleneck sits. A positive or intermediate result will usually prompt a specialist visit, confirmatory work-up and, for some patients, a discussion of anti-amyloid therapy that requires infusion chairs and MRI safety monitoring.
Most systems already have long waits for memory clinics. Without a plan, a rise in positive results could lengthen those waits, frustrate referring physicians and leave anxious families without timely answers.
Planning steps
- Decide where the test lives. Work with the laboratory and primary care leaders on whether to bring it in-house or send it out, and set clear ordering criteria aligned with the cleared use.
- Build a results pathway. Define who receives positive and intermediate results, how quickly patients are seen and what confirmatory testing follows.
- Size downstream capacity. Estimate added demand for neurology visits, PET and MRI slots and infusion chairs, and test the financial case with your payer mix.
- Prepare clinicians and patients. Primary care teams need guidance on counseling and on what a result does and does not mean.
- Track equity and access. Monitor who is tested and who reaches a specialist, so the benefit does not stop at patients already well connected to care.
Archive entry for Aug 25, 2026, added Nov. 11, 2026.