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▎WuXi AppTec Content Team Editor Diadem announced today that the U.
S.
Food and Drug Administration (FDA) has granted Breakthrough Device Designation to AlzoSure Predict, Diadem’s prognostic assay for blood-based biomarkers designed to identify with high accuracy Whether individuals over age 50 with signs of cognitive impairment progress to Alzheimer's disease before symptoms become apparent
.
According to the press release, this test can determine whether the disease will progress to Alzheimer's disease six years in advance
.
Breakthrough Device Designation is awarded to novel medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases
.
Breakthrough medical device designation gives R&D companies additional guidance from the US FDA during the development process, as well as expedited review of marketing applications
.
The AlzoSure Predict assay being developed by Diadem is a simple, non-invasive plasma biomarker-based assay
.
The company's assay includes a proprietary antibody it has developed that is designed to bind to U-p53AZ
.
U-p53AZ is a conformational variant of the p53 protein and has been implicated in the pathogenesis of Alzheimer's disease in multiple studies
.
Image source: Diadem's website The decision was supported by a longitudinal study of 482 patients
.
The study shows that AlzoSure Predict can determine whether an individual will progress to full-blown Alzheimer's disease up to 6 years before disease symptoms become apparent
.
Patients were ≥50 years of age, asymptomatic, or in the early stages of Alzheimer's disease or other dementias at the start of the study
.
The findings were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal
.
The second phase of the study, which includes biobank data from more than 1,000 additional patients in the U.
S.
and Europe, will be completed in the coming months
.
Mr.
Paul Kinnon, CEO of Diadem, said: "Receiving Breakthrough Device Designation from the US FDA confirms our view that AlzoSure Predict has the potential to transform the early identification and management of Alzheimer's disease
.
We look forward to working closely with the US FDA Collaborate to complete our clinical studies and expedite the regulatory review process
.
" Reference: [1] FDA Grants Breakthrough Device Designation to Diadem's AlzoSure® Predict Prognostic Blood Test for the Early Prediction of Alzheimer's Disease.
Retrieved January 18, 2022, from https :// -301462419.
htmlDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
S.
Food and Drug Administration (FDA) has granted Breakthrough Device Designation to AlzoSure Predict, Diadem’s prognostic assay for blood-based biomarkers designed to identify with high accuracy Whether individuals over age 50 with signs of cognitive impairment progress to Alzheimer's disease before symptoms become apparent
.
According to the press release, this test can determine whether the disease will progress to Alzheimer's disease six years in advance
.
Breakthrough Device Designation is awarded to novel medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases
.
Breakthrough medical device designation gives R&D companies additional guidance from the US FDA during the development process, as well as expedited review of marketing applications
.
The AlzoSure Predict assay being developed by Diadem is a simple, non-invasive plasma biomarker-based assay
.
The company's assay includes a proprietary antibody it has developed that is designed to bind to U-p53AZ
.
U-p53AZ is a conformational variant of the p53 protein and has been implicated in the pathogenesis of Alzheimer's disease in multiple studies
.
Image source: Diadem's website The decision was supported by a longitudinal study of 482 patients
.
The study shows that AlzoSure Predict can determine whether an individual will progress to full-blown Alzheimer's disease up to 6 years before disease symptoms become apparent
.
Patients were ≥50 years of age, asymptomatic, or in the early stages of Alzheimer's disease or other dementias at the start of the study
.
The findings were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal
.
The second phase of the study, which includes biobank data from more than 1,000 additional patients in the U.
S.
and Europe, will be completed in the coming months
.
Mr.
Paul Kinnon, CEO of Diadem, said: "Receiving Breakthrough Device Designation from the US FDA confirms our view that AlzoSure Predict has the potential to transform the early identification and management of Alzheimer's disease
.
We look forward to working closely with the US FDA Collaborate to complete our clinical studies and expedite the regulatory review process
.
" Reference: [1] FDA Grants Breakthrough Device Designation to Diadem's AlzoSure® Predict Prognostic Blood Test for the Early Prediction of Alzheimer's Disease.
Retrieved January 18, 2022, from https :// -301462419.
htmlDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
