ALZpath, a developer of diagnostics for Alzheimer's disease and related dementias, announced that it has signed a licensing agreement with Roche for the use of the ALZpath pTau217 antibody to develop and commercialize a diagnostic blood test for Alzheimer's that will be offered on the Roche Elecsys platform.
Roche's pTau217 test was recently granted a breakthrough device designation by the U.S. Food and Drug Administration; it was developed and will be commercialized as part of an ongoing collaboration between Roche and Lilly.
"The field has been waiting for highly accurate and reliable plasma pTau217 assays on widely available, fully automated commercial testing platforms, and we are thrilled that ALZpath's proprietary antibody has been selected by Roche to play that vital role on the Elecsys platform," Venkat Shastri, ALZpath's CEO, said.
Blood-based assays using the pTau217 antibody as a biomarker have been shown to have similar accuracy and reliability as the more expensive and invasive PET imaging or cerebral spinal fluid (CSF) testing usually used for diagnosis of Alzheimer's disease, ALZpath noted in a statement.