Neurocode launches ALZpath blood test for Alzheimer’s diagnosis

Innovative blood test that offers fast and accessible way to diagnose and monitor Alzheimer’s disease hits the clinic.

ALZpath’s pTau217 test, which a recent study suggests could be as accurate as a spinal tap, is now available for clinical diagnostic use.

Neurocode USA, a specialized clinical laboratory that offers testing solutions for neurological disorders, has announced the clinical launch of ALZpath Dx, an innovative and novel blood test that can be used in the screening, diagnosis and monitoring of Alzheimer’s disease based on circulating level of pTau217 in the blood.

Longevity.Technology: Neurocode is the first laboratory in the US to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes, and this should hopefully make an impact on Alzheimer’s, one of the areas in medicine with the highest unmet medical need. While emerging pharmaceutical interventions offer some promise, they predominantly slow the advancement of early-stage Alzheimer’s; therefore, the imperative for timely and precise diagnosis looms large, and introducing a blood assay capable of swiftly and effectively discerning the disease’s onset would indeed represent a transformative milestone in Alzheimer’s therapeutic strategies. This advancement carries profound implications given the staggering global burden of Alzheimer’s, underscoring the pressing necessity for innovative diagnostic modalities.

Neurocode’s pioneering assay measures levels of phosphorylated tau at position 217 (pTau217). The idea of using pTau217 as a diagnostic test for Alzheimer’s has been around for a while, and pTau217 is widely considered to be a transformative blood-based biomarker, one that will enable earlier and more accurate Alzheimer’s diagnosis. It will also foster better stratification of patients for clinical trials, improved patient care and treatment, and greater diagnostic specificity and sensitivity. The test, which is powered by the Simoa (single-molecule assay) technology of Quanterix Corp, must be ordered by a healthcare provider; sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site.

“The clinical availability of the ALZpath Dx test is significant as it provides a more scalable, more accessible, and less invasive option for the diagnosis of patients in earlier stages of the disease, when recently-approved disease-modifying therapies are most beneficial. Patients and their families gain unprecedented ease of access to early and accurate diagnosis and the opportunity for timely treatment,” said Ryan Fortna, MD PhD, Medical Director of Neurocode. “Additionally, this blood-based test is as accurate as brain imaging or CSF testing, but is faster, more accessible, less expensive, and less invasive, and it does not require radiation exposure.”

Recently, ALZpath announced results of an international peer-reviewed study published in JAMA Neurology, evaluating the performance of its ALZpath Dx assay in a 786-patient study. The findings demonstrated that the ultra-sensitive immunoassay showed high diagnostic accuracy in identifying elevated amyloid in the brain across all cohorts. The accuracy was significantly higher than other blood-based biomarker combinations and equivalent to cerebrospinal fluid (spinal tap) biomarkers. It demonstrated high accuracy in predicting Alzheimer’s brain pathologies (amyloid-beta plaques and tau tangles) as identified by positron emission tomography (PET) imaging, the current gold standard diagnostic technique [1].

Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility. Their validation study used over 1,700 samples with amyloid PET imaging and 150 subjects with post-mortem (autopsy) pathology, demonstrating an area under the curve (AUC) of 0.94, significantly exceeding the 90% accuracy threshold for a standalone diagnostic Alzheimer’s test proposed by the Alzheimer’s Association Workgroup [2].

Neurocode launches ALZpath blood test for Alzheimer's diagnosis
Andreas Jeromin, PhD, ALZpath Chief Scientific Officer

Andreas Jeromin, PhD, Chief Scientific Officer of ALZpath, said: “The availability of ALZpath Dx in our first partner laboratory marks a significant milestone in making this test available for clinical use, and we are thrilled to collaborate with Neurocode. Looking ahead, ALZpath is planning to expand our network to help patients, their families, health care providers and pharmaceutical/biotech companies, and to improve care and management of a disease that devastates so many lives.”

Following the launch with Neurocode, ALZpath has plans to partner with additional US labs, and ALZpath Dx is available for research use as part of the “Biomarker Factory” at UCL; additionally, ALZpath is in discussions with additional labs in the UK to launch for clinical use.

[1] https://jamanetwork.com/journals/jamaneurology/fullarticle/2813751
[2] https://alz.org/media/Documents/scientific-conferences/Clinical-Criteria-for-Staging-and-Diagnosis-for-Public-Comment-Draft-2.pdf

Photograph courtesy of ALZpath