September 20, 2022

Araclon Biotech obtains CE mark for early-stage Alzheimer’s disease diagnostic tests

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  • ABtest-MS and ABtest-IA are the first tests developed by a Spanish company for the measurement of amyloid peptides in blood to assist in assessing the risk of Alzheimer's disease. This certification is applicable in all European Union countries, Iceland, Liechtenstein and Norway
  • Through mass spectrometry (ABtest-MS) and ELISA (ABtest-IA), both tests can quantify Aβ40 and Aβ42 proteins – both associated with the risk of getting AD – in biological samples
  • Both tests are currently available in a research environment through the ABtestService: for plasma samples in the case of ABtest-MS, and plasma and cerebrospinal fluid (CSF) for ABtest-IA.
  • Receiving the CE mark represents another step towards incorporating ABtest-MS and ABtest-IA into routine clinical practices for future Alzheimer's disease diagnosis as they constitute a reliable, minimally invasive, highly agile and cost-effective detection tool using plasma samples.

Zaragoza, Sept. 20, 2022 - Araclon Biotech, a Grifols Group company dedicated to the research and development of therapies and diagnostic methods applied to Alzheimer’s disease (AD), has obtained the CE mark for its two early-stage diagnostic tests, ABtest-MS and ABtest-IA. Both tests are capable of quantifying Aβ40 and Aβ42 proteins, whose accumulation in the brain is considered the first pathological change related to AD1. ABtest-IA also allows their quantification in cerebrospinal fluid (CSF).

ABtest-MS and ABtest-IA are the first AD risk-assessment tests developed by a Spanish company to obtain the CE mark, applicable in all European Union countries, Iceland, Liechtenstein and Norway. Certification is a step forward for Araclon Biotech, whose objective is to incorporate the tests into routine clinical practices for future Alzheimer's diagnosis. 

When applied to plasma samples, the tests contribute to diagnosis through an agile, reliable and minimally invasive method that is less costly than alternatives. In addition, the use of these plasma tests as pre-screening (triage) tools could considerably accelerate and lower the cost of recruitment for clinical trials of new treatments.

“Obtaining the CE mark for our early Alzheimer's disease diagnostic tests reinforces our commitment to researchers, healthcare professionals and patients, as it advances our roadmap to establish them as Alzheimer's screening standards in the future. These tests have been validated in several studies, involved thousands of clinical samples and can predict the presence of brain amyloid deposits in initial stages of the disease, which could facilitate its early management,” explains Jose Terencio, Araclon CEO and vice president of Innovation at Grifols.

Both tests are currently available in a research environment, including centers specialized in AD research and experimental researchers who specialize in this neurodegenerative disease, through the ABtestService, which offers both test options in plasma samples, as well as CSF samples (ABtest-IA only).

ABtest-MS and ABtest-IA: two innovative tests which accurately quantify Aβ40 and Aβ42 proteins associated with Alzheimer’s disease.

ABtest-MS and ABtest-IA are two innovative methods developed entirely by Araclon and capable of accurately quantifying Aβ40 and Aβ42 proteins in plasma samples. ABtest-MS is based on liquid chromatography coupled to mass spectrometry, while ABtest-IA uses the ELISA immunoassay technique and can also quantify both proteins in CSF.

The results of recent studies, which have been presented at international congresses2,3, demonstrate the high predictive ability of ABtest-MS to accurately identify subjects with cerebral amyloid load, a sign indicative of early-stage AD. These data support preliminary results of recently published studies in high-impact scientific journals such as Alzheimer's Research & Therapy4, Nature Aging5 and Alzheimer's & Dementia: The journal of the Alzheimer's Association6, confirming that beta-amyloid biomarkers measured with ABtest-MS in plasma are linked to AD.

In turn, ABtest-IA has also evidenced a close association between plasma β-amyloid protein levels and amyloid deposits in the brain7,8. Furthermore, ABtest-IA has been able to predict longitudinal changes in the course of Alzheimer's disease, demonstrating that lower levels of the Aβ42/Aβ40 ratio are associated with a greater accumulation of brain amyloid over time9 and a higher risk of progression to dementia10.

In addition, the ABTest-MS will be used to analyze samples from a patient cohort at risk of AD as part of a study being led by New York University’s Grossman School of Medicine.

1 Hansson, O. Biomarkers for neurodegenerative diseases. Nat Med 2021, 27, 954–963. https://doi.org/10.1038/s41591-021-01382-x

2 Plasma Aβ42/Aβ40, measured by a novel mass spectrometric method, identifies early amyloid deposition in individuals at risk of Alzheimer’s disease (FACEHBI Cohort). Allúe JA et al. Oral presentation, Barcelona, 19/03/2022, AD/PD Congress, 2022.

3 Accurate discrimination of brain amyloid status in the multi-centric a4 study by plasma Aβ42/Aβ40 measured with a novel HPLC-MS/MS method. Sarasa L et al. Poster presentation.

4 Jang H, Kim JS, Lee HJ, Kim CH, Na DL, Kim HJ, Allué JA, Sarasa L, Castillo S, Pesini P, Gallacher J, Seo SW; DPUK. Performance of the plasma Aβ42/Aβ40 ratio, measured with a novel HPLC-MS/MS method, as a biomarker of amyloid PET status in a DPUK-KOREAN cohort. Alzheimers Res Ther. 2021 Oct 22;13(1):179. doi: 10.1186/s13195-021-00911-7. PMID: 34686209; PMCID: PMC8540152.

5 Cullen, N.C., Leuzy, A., Palmqvist, S. et al. Individualized prognosis of cognitive decline and dementia in mild cognitive impairment based on plasma biomarker combinations. Nat Aging 1, 114–123 (2021). https://doi.org/10.1038/s43587-020-00003-5

6 Janelidze S, Palmqvist S, Leuzy A, Stomrud E, Verberk IMW, Zetterberg H, Ashton NJ, Pesini P, Sarasa L, Allué JA, Teunissen CE, Dage JL, Blennow K, Mattsson-Carlgren N, Hansson O. Detecting amyloid positivity in early Alzheimer's disease using combinations of plasma Aβ42/Aβ40 and p-tau. Alzheimers Dement. 2022 Feb;18(2):283-293. doi: 10.1002/alz.12395. Epub 2021 Jun 20. PMID: 34151519.

7 Pérez-Grijalba V, Arbizu J, Romero J, Prieto E, Pesini P, Sarasa L, Guillen F, Monleón I, San-José I, Martínez-Lage P, Munuera J, Hernández I, Buendía M, Sotolongo-Grau O, Alegret M, Ruiz A, Tárraga L, Boada M, Sarasa M; AB255 Study Group. Plasma Aβ42/40 ratio alone or combined with FDG-PET can accurately predict amyloid-PET positivity: a cross-sectional analysis from the AB255 Study. Alzheimers Res Ther. 2019 Dec 1;11(1):96. doi: 10.1186/s13195-019-0549-1. PMID: 31787105; PMCID: PMC6886187.

8 Doecke JD, Pérez-Grijalba V, Fandos N, Fowler C, Villemagne VL, Masters CL, Pesini P, Sarasa M; AIBL Research Group. Total Aβ42/Aβ40 ratio in plasma predicts amyloid-PET status, independent of clinical AD diagnosis. Neurology. 2020 Apr 14;94(15):e1580-e1591. doi: 10.1212/WNL.0000000000009240. Epub 2020 Mar 16. PMID: 32179698; PMCID: PMC7251518.

9 Fandos N, Pérez-Grijalba V, Pesini P, Olmos S, Bossa M, Villemagne VL, Doecke J, Fowler C, Masters CL, Sarasa M; AIBL Research Group. Plasma amyloid β 42/40 ratios as biomarkers for amyloid β cerebral deposition in cognitively normal individuals. Alzheimers Dement (Amst). 2017 Sep 12; 8:179-187. doi: 10.1016/j.dadm.2017.07.004. PMID: 28948206; PMCID: PMC5602863.

10 Pérez-Grijalba V, Romero J, Pesini P, Sarasa L, Monleón I, San-José I, Arbizu J, Martínez-Lage P, Munuera J, Ruiz A, Tárraga L, Boada M, Sarasa M. Plasma Aβ42/40 Ratio Detects Early Stages of Alzheimer's Disease and Correlates with CSF and Neuroimaging Biomarkers in the AB255 Study. J Prev Alzheimers Dis. 2019;6(1):34-41. doi: 10.14283/jpad.2018.41. PMID: 30569084.