Laboratory services provider Labcorp has launched its standalone phosphorylated tau 217 (pTau217) blood biomarker test, for the diagnosis of Alzheimer’s disease. 

The test is designed to identify the presence or absence of biomarker pTau217. Elevated levels of pTau217 in cerebrospinal fluid have been associated with the presence of Alzheimer’s pathology, including the accumulation of tau protein tangles in the brain.

Studies have shown pTau217 to be more specific to Alzheimer’s compared to other forms of dementia, making it a valuable tool for early diagnosis. 

Labcorp’s pTau-217 test can also be used for monitoring patients on newly approved anti-amyloid therapy, according to Labcorp in the 20 March press release. The test is not US Food and Drug Administration (FDA) approved. 

A recent change to FDA rules now means that laboratory-developed tests (LDT) are set to be regulated as medical devices. One of the new policies announced in October 2023 intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach. The FDA said this rule will not apply to all LDTs currently on the market. 

In October 2023, Labcorp launched its ATN Profile test, which combines three blood biomarkers: amyloid plaques, tau tangles and neurodegeneration (ATN), to detect and evaluate the disease’s biological changes.  

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The company also has two other Alzheimer’s tests in its portfolio, the Neurofilament light chain (NfL) and Beta-amyloid 42/40 ratio tests. According to a report on GlobalData’s Pharma Intelligence Center, the Alzheimer’s disease market is forecast to generate $15.9bn in global sales by 2030. 

In the announcement accompanying the launch, Labcorp’s chief medical and scientific officer Brian Caveney said: “The introduction of pTau217 represents a significant milestone in our ongoing commitment to advancing testing capabilities across the spectrum of Alzheimer’s disease. 

“By expanding our suite of blood-based biomarker tests, we are empowering clinicians and pharma with more tools for clinical trials and for the detection and monitoring of Alzheimer’s to improve patient care.” 

Earlier this month, Washington-based clinical laboratory Neurocode USA announced the launch of its pTau217 blood test ALZpath Dx to detect Alzheimer’s disease.