AltPep Corp., a privately held biotechnology company dedicated to early disease-modifying treatments and detection tools for amyloid diseases, announced that the peer-reviewed Nature journal Scientific Reports published new results from the company’s evaluation of its novel SOBA-AD blood test, aimed at detecting Alzheimer’s disease (AD).

Blood-Based Tool for Alzheimer’s Detection

The data, consistent with an earlier study, further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of Alzheimer’s disease. The SOBA-AD blood test targets toxic soluble oligomers, an early molecular trigger of amyloid diseases, with the ultimate goal of identifying patients with the disease years before symptoms manifest.

In the report titled “Performance of SOBA-AD blood test in discriminating Alzheimer’s disease patients from cognitively unimpaired controls in two independent cohorts,” 265 blinded plasma samples from two independent cohorts were tested at two different sites. The SOBA-AD blood test identified AD patients from cognitively unimpaired (CU) subjects with 100% sensitivity, >95% specificity, and >98% area under the curve (95% CI 0.95-1.00).

“Moving forward, AD will be defined biologically at the molecular level vs by clinical symptoms alone,” says Valerie Daggett, PhD, founder and CEO of AltPep. “These results for our simple SOBA-AD blood test support the goal of earlier, pre-symptomatic detection of patients with AD. AltPep’s technology stands apart from others because it rationally targets a specific nonstandard protein structure called alpha-sheet, which is present in toxic oligomers that form both early and throughout the disease process. This novel test, now run successfully at multiple locations, has the potential to have profound implications as a biomarker for AD clinical trials as well as a diagnostic for earlier treatment of the disease.”

Further reading: How Amyloid Blood Test Could Transform Alzheimer’s Diagnostics

Results of the SOBA-AD Blood Test Study

In the new study, the SOBA-AD blood test effectively differentiated clinically diagnosed Alzheimer’s disease patients from CU controls with high specificity and sensitivity across 265 samples. 

Combining these results with prior research, a comprehensive analysis of 644 samples consistently exhibited high performance metrics, with sensitivity ranging from 99 to 100%, specificity from 95 to 100%, and an area under the curve from 98 to 100%. In addition to expanding the cohorts from one to three and including two independent sites (AltPep and the University of Washington) with separate equipment and operators, this study increased diversity among the samples.

In the prior research, a number of CU subjects tested positive who later converted to Mild Cognitive Impairment (MCI) or Alzheimer’s, as confirmed by clinical evaluation or neuropathology. These results support the potential for early detection in preclinical stages. In this study, five CU controls tested positive for AD according to the assay. While confirmatory data were unavailable for these five cases, it is plausible these subjects also have pre-symptomatic disease. Follow-up is still being pursued.