FDA clears WashU-developed blood test that spots Alzheimer's with over 90% accuracy
FDA clears blood test to aid evaluation for Alzheimer's disease
The FDA has cleared PrecivityAD2, a blood test based on technology invented at Washington University School of Medicine in St. Louis, to aid in diagnosing Alzheimer's disease. The test detects amyloid plaque biomarkers with over 90% accuracy, offering a less invasive alternative to spinal taps and brain scans. Developed by C2N Diagnostics, a WashU startup, the test uses high-resolution mass spectrometry to measure amyloid and tau proteins. Early detection is crucial as new treatments are most effective when started early.
With FDA clearance, this innovation can reach more patients, increasing early and accurate diagnoses for people who are seeking causes of cognitive symptoms such as memory loss.
- brandonb
This Alzheimer's blood test, PrecivityAD2, is based on the p-tau217 biomarker.
In one recent study, people very high p-tau217 had a 38% chance of progressing to cognitive impairment within 5 years vs 12% for those with low levels. The current tests cost about $200-300, so they're not unreasonable as a screening test. PrecivityAD2 looks to be priced around $1,400-$1,500 so at that price, this specific test likely only makes sense for people with established disease.
- ggm
Do we yet have any good avoidance or mitigation regimes, be they drug or otherwise for people who show positive on a test like this? The alternative is that it lets you put things in place for when you lose agency.
Good as in scientifically proven. Not speculative fantasy.
- debo_
I work directly in this field (clinically validated digital cognitive tests that characterize cognition, often paired with p-tau blood tests.) Ask me anything, I guess!
- Pawenniag
If this gets cheap enough and the predictive values hold up in ordinary clinical populations, it could change when people actually get evaluated rather than just how they get evaluated
- willmadden
Why is the FDA "clearing" something that is completely innocuous like a blood test?
- hn_submit
These tests are more or less useless because there's no treatment anyway so knowing about it a long time in advance will not lead to any substantial gain. Even slowing the disease isn't within the realm of today's technology. Today's pharmaceutical companies are close to quacks as far as Alzheimer is concerned. We know next to nothing about its origins or even how the disease progresses.
The only thing you gain is giving people more time to worry and despair.