Will be available in clinical settings soon
Development of biomarkers for Alzheimer’s disease (AD) has been the main focus of recent research. However, the high cost and invasiveness of cerebrospinal fluid (CSF) and positron emission tomography (PET) biomarkers have limited their use in the research and clinical settings. Therefore, the reliable and more accessible blood-based biomarkers hold promise for diagnosis of AD in both settings.
PeopleBio (KOSDAQ: 304840) announced on December 16th that its novel blood-based screening tool for AD, called ‘OAβ test’, passed the New Health Technology Assessment (nHTA) that was introduced in 2007 to evaluate the safety and clinical usefulness of new medical technologies including diagnostics and therapeutics in South Korea. Previously, PeopleBio had applied for the nHTA in 2019 but in vain.
The OAβ test uses the Multimer Detection System (MDS) technology to measure the oligomerization levels of beta-amyloids before the onset of AD symptoms. Using the cut-off value of 0.78 ng/ml, the test revealed 100% sensitivity and 92.31% specificity for the prediction of AD. Thus, the test is believed to help the early prediction and diagnosis of AD in the clinical setting and also to lower the cost of clinical trials by identifying the participants easily and quickly. The cost is expected not to exceed $100, which is quite cheaper than that for amyloid PET test being about $1,000 ~ $1,500 in South Korea.
Similarly, the ‘PrecivityAD’ test developed by C2N Diagnostics in St. Louis, Missouri became available in October 2020 in the U.S. The PrecivityAD uses the mass spectrometry technique to measure multiple biomarkers (Aβ42, Aβ40, and apolipoprotein E isoforms) in blood. With the 60% prevalence of amyloid PET positivity, the test showed 92% sensitivity and 77% specificity in identifying the amyloid plaques. This blood test costs $1,250, relatively cheap compared to the cost for amyloid PET or CSF analysis that is approximately $4,000 ~ $5,000 in the U.S. However, it is not covered by insurance yet.
Meanwhile, PeopleBio signed a contract with Singapore's All Eights to supply a total of $1.7 million worth of ‘OAβ test’ kits for three years last month.
Related Research Article
Youn YC, Lee BS, Kim GJ, Ryu JS, Lim K, Lee R, Suh J, Park YH, Pyun JM, Ryu N, Kang MJ, Kim HR, Kang S, An SSA, Kim S. Blood Amyloid-β Oligomerization as a Biomarker of Alzheimer's Disease: A Blinded Validation Study. J Alzheimers Dis. 2020;75(2):493-499.
Related Review Article
Chong JR, Ashton NJ, Karikari TK, Tanaka T, Schöll M, Zetterberg H, Blennow K, Chen CP, Lai MKP. Blood-based high sensitivity measurements of beta-amyloid and phosphorylated tau as biomarkers of Alzheimer's disease: a focused review on recent advances. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1231-1241.