Danaher (DHR) Gets CE Mark for Alzheimer's Blood Test

Danaher (DHR) announced that its Beckman Coulter Diagnostics unit has obtained CE Mark certification under the EU's IVDR for its Access p-Tau217 blood assay, designed for early detection of Alzheimer's disease. The milestone comes as DHR shares have declined 17.2% year-to-date.

The Product

The Access p-Tau217 assay measures levels of the p-Tau217 protein, a biomarker for Alzheimer's disease. It enables early detection before clinical symptoms appear, potentially improving treatment outcomes.

Pricing and Availability

Danaher has not disclosed specific pricing for the test. It will be available in markets recognizing the CE Mark, primarily in Europe. Commercial rollout is expected in the coming months.

Competition

The test faces competition from other companies developing similar blood-based Alzheimer's tests, including Roche and Quanterix. However, the p-Tau217 assay has shown high accuracy in preliminary studies.

Potential Impact on Danaher

The launch represents a strategic move into the rapidly growing neurodiagnostics market. With the rising global prevalence of Alzheimer's, the test could boost Danaher's diagnostics revenue. However, the stock remains under pressure due to broader year-to-date weakness.