C2N Diagnostics reported positive results for its APTUS-Aβ blood test for beta-amyloid (Aβ) isoforms 42 and 40 for early Alzheimer's pathology in a multicenter U.S. proof-of-concept study of 415 samples taken from six different locations.
C2N Diagnostics is based at the Center for Emerging Technologies in St. Louis. The privately held startup was formed by Dr. David Holtzman and Dr. Randall Bateman of the Washington University School of Medicine in St. Louis, which has been at the lead in developing a diagnostic for Alzheimer's disease. Research has moved toward testing a biomarker composite derived from ratios of plasma levels of amyloid-related peptides.
The latest data were discussed in a late-breaking presentation at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in San Diego. The researchers reported an area under the curve performance of 0.86, which rose to 0.90 when other key factors, such as age and apolipoprotein E E4 (APOE E4) genetic status, were taken into account. The company said it may be possible to improve accuracy even further through a number of tweaks, including the standardization of sample collection.
The APTUS test, which has received breakthrough designation from the U.S. Food and Drug Administration, is being evaluated in the PARIS study, which the company will use for registrational purposes. C2N also plans to launch a CLIA version of the test.
"We realize the urgency for developing a reliable blood test that will help identify individuals with early Alzheimer's pathology," CEO Dr. Joel Braunstein said in a statement. "This test will come at a much lower cost and hassle than existing methods of detecting brain amyloidosis."
In separate but related news, the Alzheimer's Drug Discovery Foundation Diagnostics Accelerator announced six new investments in innovative research worth a total of $6 million. Backed by Bill Gates and Jeff and MacKenzie Bezos, among other philanthropists, the organization is working to encourage the development of new biomarkers for dementia disorders.
New recipients include Dr. Henrik Zetterberg of the University of Gothenberg in Sweden, who was awarded $3,197,896 for his research in developing a Aβ42/Aβ40 blood test for Alzheimer's disease in collaboration with Roche. In addition, Laura Ibanez, PhD, of the Washington University School of Medicine in St. Louis is set to receive $281,370 for research into a test for measuring cell-free RNA (cfRNA) in Alzheimer's disease.