a historic advancement in clinical trial Testing
CyTOF (Time-of-Flight Mass Cytometry)
CyTOF provides the most comprehensive understanding of cell phenotypes, signaling pathways and function in the world today, enabling system-level biology at single-cell resolution. Single-cell proteomics, the large-scale study of proteins, represents an advanced method of measuring and phenotyping cells that can generate an unprecedented level of detailed data about cells from relatively small samples. The data helps identify previously undetected cell subsets, deepening understanding of unique cell biology and potential for disease. With CyTOF, we capture over 70 biomarkers relating to human peripheral blood, T cell phenotyping, T cell phenotype expansion, and a hemopoietic stem/progenitor panel.
Mass spectrometry (MS) for Alzheimer's
Mass spectrometry (MS) is an analytical technique that measures the masses within a sample.
Novel Alzheimer’s Disease detection assay We use highly sensitive immunoprecipitation-mass spectrometry to measure plasma amyloid O-proteins and AO- approximate peptides (AOAPs) cleaved from amyloid precursor protein (APP), to detect cerebral amyloid deposition with clinically demonstrated equivalency to PET scan in the detection of Alzheimer's disease using only a blood sample. We utilize this blood-based biomarker in lieu of a Cerebral Spinal Fluid (CSF) examination, which requires an invasive lumbar puncture, creating potentially greater risk of complications to subjects. Subjects responsive to this biomarker may predictively affirm potential early onset of Alzheimer's, as well as the effects of Heterochronic Plasma Exchange in mitigating or remediating key biomarkers of Alzheimer's disease, as indicated by cerebral amyloid deposition.
We measure genetic health risk on a range of health conditions, including late-onset Alzheimer’s disease, Parkinson’s disease and alpha-1 antitrypsin deficiency which we can cross-correlate with other biomarkers. We genotype specific genetic variants in the genome relevant to individual health and ancestry, including medically relevant genes with known disease associations and associated with traits, to assign genetic ancestry and ethnicity.
“BIG DATA” Database & Analytics
We have developed a unique capability to ingest and analyze very large amounts of scientific and medical data, making a leap forward in precision health and clinical trial analysis and diagnostics. Rather than limit testing, we ingest as much data as possible and then target database queries for specific bioinformatics subsets.
"Deep Learning" Artificial Intelligence
The combination of 7 complimentary and advanced, state-of-the-art, ultrasensitive, high-precision measurement technologies to capture comprehensive data about the human body has never been seen by scientists or doctors before. When we include the subject medical history and physician observations across the study pool, we create significant amounts of ultra-sensitive, high-precision data we characterize as the "big data" of the body. In order to discover as many possible early detection triggers for potential disorders, individually and collectively, we have utilize "deep learning" software and apply artificial or augmented intelligence technologies to support clinical scientific observations and assessments for each Subject and across the collective Subject pool comparatively – as well a diagnostic dashboard for simplified viewing via a cloud-based interface.
Blood and Tissue Sample Cryopreservation / Storage
We will cryopreserve samples of all blood draws at all points in time – before, during, after, and 6 months after, the intervention itself – so that we may re-run additional tests as desired in the future, if and when additional testing technologies become available.
ELISA; Digital ELISA
ELISA (enzyme-linked immunosorbent assay) technologies detect substances that have antigenic properties, primarily proteins rather than small molecules and ions, such as glucose and potassium. A plate-based assay technique ELISA is designed for detecting and quantifying substances such as peptides, proteins, antibodies and hormones.
Digital ELISA is 100-3,500 times more sensitive than traditional ELISA, enabling the detection and quantification of biomarkers previously difficult or impossible to measure with automated, consistent results (no operator variation), offering the most highly sensitive and accurate ELISA detection of cytokines in the world. We capture 4 ELISA biomarkers and 24 Digital ELISA biomarkers, including ultra-sensitive immunological and neurological assays, as well as markers of chronic inflammatory conditions.
DNA Methylation Biomarkers (500 loci)
Eukaryotes control gene expression, but DNA methylation, a chemical reaction that occurs in every cell and tissue the body, is the process of adding methyl groups to a molecule that has been observed as a common epigenetic signaling tool used by cells to lock genes in the "off" position. DNA methylation may be an important component in numerous cellular processes, including embryonic development, genomic imprinting, X-chromosome inactivation, and preservation of chromosome stability. DNA can be modified by methylation of cytosine bases, particularly cytosines preceding guanines (CpG dinucleotides), by enzymes called DNA methyltransferases. This epigenetic modification generally functions to repress gene expression and is important for the regulation of cellular differentiation and development. DNA methylation can also serve as an epigenetic biomarker for many human diseases associated with biological aging. We use bisulfite treatment of DNA to determine its pattern of methylation, considered the "gold standard" to assess DNA methylation status and epigenetic clock analysis, a type of DNA clock based on measuring natural DNA methylation levels to estimate the "biological age" of a tissue, cell type or organ. Our DNA methylation analysis will capture over 500 CpG sites contributing to a combinatorial assessment.
Continuous Digital Biomarkers
We provide Apple Watch, the premier platform for measurement and monitoring of continuous digital biomarkers, to Subjects, in order to collect, compare, and correlate the predictive capabilities of our comprehensive scientific measurements, in the specific context of this Study, with the predictive capabilities of digital biomarkers. This data will provide investigators a window into a patient’s day-to-day status between physician visits and as well as a longitudinal collection of real-world information, analyzed in conjunction with clinical and molecular data, complimenting deep, comprehensive measurement of cells, proteins, methylation markers, and standard blood tests collected through scientific devices and equipment. This data can be compared to publicly available data, resting BPM for example, et al., as well as anonymously with other Study Subjects, enabling investigators to create digital phenotypes for Subjects and their response to therapies to further personalize assessment of intervention(s).
As organisms grow, cells divide to produce new cells to replace old, damaged cells. During cell division, in order for chromosomes to remain intact and evenly distributed among cell, telomeres – the repetitive, non-coding stretches of DNA located at the ends of chromosomes – act as protective endcaps to prevent chromosomes from unraveling. This telomeric protection helps ensure DNA divisions replicate accurately. In the cell division process, telomeres lose a small fraction of their DNA each time a cell divides. As cells age, they lose telomeric DNA, and, ultimately, the cell cannot replicate and dies. Measurement of the loss of telomeric DNA, or the rate of loss, serves as another biological aging clock for cellular senescence.