Tuesday, April 29, 2025
4/29/2025
Whole blood filter paper assay for Alzheimers Disease - BioSpyder proposes to develop and validate a classifier test for Alzheimer’s Disease (AD) that may also classify other dementias. This Diversity supplement will extend the scope to include a test for Parkinson’s Disease (PD). BioSpyder intends to market these tests as RUO products initially, then pursue the development of definitive in vitro diagnostic (IVD) tests, addressing a major unmet need. In Phase I, a classifier was demonstrated using whole blood obtained from a finger-stick, spotted on filter paper, and assayed using the whole transcriptome TempO-Seq® gene expression assay (the WBFP TempO-Seq assay). This approach produced signatures for both AD and PD, enabling the construction of a classifier that initially identified each with 87% accuracy. After retraining with additional AD samples, the WBFP TempO-Seq AD classifier identified 100% of an independent testing cohort of AD samples correctly and identified immune cell functional pathways underlying the signature. AD is the most common form of dementia, with the risk of developing AD being 1 in 5 for women and 1 in 10 for men. Mild cognitive impairment (MCI) can be noticed years before those patients can be diagnosed with AD or another dementia, resulting in years of uncertainty, lack of treatment, and lost time to prepare for a future with AD. That diagnosis requires cognitive testing administered by a neurologist, preferably confirmed by a -amyloid PET scan. Biomarker immunoassays recently cleared under the Breakthrough Device designation are not definitive and require cognitive testing or a -amyloid PET scan for diagnosis, along with the need for drawing blood or collecting cerebral spinal fluid. Thus, the unmet need for a definitive IVD persists. In this Phase II we will validate the performance of the WBFP TempO-Seq assay to classify AD patients, ability to classify patients with other dementias, establish how early after presenting with MCI patients can be identified with AD, correlate the WBFP TempO-Seq assay classification to -amyloid PET scans and immunoassay, implement/validate performance of a focused WBFP TempO-Seq AD or pan- dementia test, and prepare the materials for, and meet with, the FDA in a pre-IDE meeting to discuss the studies required for an application for clearance as an IVD. The diversity supplement will carry this out for PD. These tests will be marketed for RUO use to identify novel therapeutic targets, characterize the progression from MCI to AD and PD, facilitate drug discovery efforts and aid in selection/classification of patients, and potentially for development as companion diagnostic tests. If the WBFP TempO-Seq AD, PD, or pan-dementia tests receive FDA clearance, they will be transformative, providing a definitive diagnosis of AD, PD, or other dementias. This could potentially happen before a diagnosis through cognitive testing can be made, and importantly, enabling self-collection of samples to address health disparities.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).