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First Commercial Alzheimer’s Blood Test Available For Purchase, But Not Yet FDA-Approved

by DailyHealthPost Editorial

The first ever commercial Alzheimer’s blood test is on the market. But don’t get your hopes up too quickly. Although the company is quick to share data showing the superiority of their blood test against PET scans, it does not mean that their product is 100% accurate.

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Currently, the only way to diagnose someone with Alzheimer’s with 100% accuracy is through an autopsy after a patient has passed away.

The blood test developed by C2N Diagnostics is specifically designed for people 60 and older who are experiencing cognitive impairment, and who are seeking a cost-effective way to test for Alzheimer’s.

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According to CBS, the test is less expensive than getting regular amyloid PET scans, which typically aren’t covered by insurance. The C2N test sold under the brand name PrecivityAD costs $1,250 and is offered with income-based discounts.

Two Major Limitations of The C2N Alzheimer’s Blood Test

Independent experts are leery because key test results have not been published and the test has not been approved by the U.S. Food and Drug Administration (FDA) — it’s being sold under more general rules for commercial labs.

“I think there are two key steps that need to happen before this test really becomes more widespread,” internal medicine specialist Dr. Karen Abrashkin said on CBSN. “One is that we need to see the data that’s being used to develop the test. We haven’t seen that data yet. It hasn’t been published and so we don’t know how sensitive or specific this test is for Alzheimer’s.”

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The other, according to Abrashkin, is FDA clearance.

“That’s really a stamp of approval that needs to happen before the test becomes more widespread,” she said.

The Future of Blood Tests for Alzheimer’s

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There are quite a few number of different tests undergoing development over the past several years. Many are designed to detect the disease’s key biomarkers — beta-amyloid and tau proteins in the brain — via blood plasma. While most Alzheimer’s blood tests underway are still years from completion, there is no doubt that over time we will see more and more tests being created with increasing accuracy.

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