C2N Diagnostics has launched two new blood tests for clinical researchers studying Alzheimer's disease and related dementias. The C2N eMTBR-tau243 test selectively detects a specific region of tau, while the C2N %p-tau MAA measures multiple phosphorylated tau forms from a single sample. These tests aim to improve disease staging, predict disease progression, and monitor treatment efficacy. C2N plans to integrate the tests into clinical routine in the future.
Quest Diagnostics has announced its plans to offer a newly FDA-cleared blood test to aid in the diagnosis of Alzheimer's disease (AD) by the end of the summer. The company will provide laboratory testing based on the Lumipulse G pTau 217/β-Amyloid (Aβ) 1-42 Plasma Ratio test developed by Fujirebio, the first blood-based in vitro diagnostic (IVD) test authorized by the FDA to help detect the amyloid pathology characteristic of AD in adults aged 50 years and older exhibiting signs and symptoms of cognitive decline [1].
According to the company, the test demonstrated a 92% positive predictive value and 97% negative predictive value for AD in a clinical study of 499 adults representative of the US population. The test will be available across Quest's network of approximately 2,000 US patient service centers [1].
Quest Diagnostics currently offers a suite of lab-developed tests under its AD-Detect portfolio, which measure plasma levels of Aβ42 and 40 to assess the risk of AD progression. The addition of the Fujirebio test will extend this portfolio to include an FDA-cleared option for use in specialized care settings [1].
The introduction of this new test aligns with the growing demand for scalable, accessible, and informative early detection tools for AD. With nearly 7 million Americans living with Alzheimer's disease and the figure projected to double by 2060, the need for effective early detection tools continues to grow [1].
Quest Diagnostics will showcase its complete line-up of Alzheimer's and other neurological test innovations at the Alzheimer's Association International Conference in Toronto from July 27 to 31, 2025 [1].
References:
[1] https://www.patientcareonline.com/view/quest-will-offer-fda-cleared-fujirebio-blood-test-to-detect-alzheimer-disease
[2] https://www.ainvest.com/news/quest-diagnostics-partners-fujirebio-offer-alzheimer-diagnostic-test-2507/
Comments
No comments yet