High throughput DNA damage quantification of human tissue with home-based collection device
Inventors
Costes, Sylvain V. • Tang, Jonathan • Yannone, Steven M.
Assignees
Exogen Biotechnology Inc • University of California San Diego UCSD • University of California Irvine
Publication Number
US-9931634-B2
Publication Date
2018-04-03
Expiration Date
2035-02-27
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Abstract
Kits, methods and systems for providing a service to provide a subject with information regarding the state of a subject's DNA damage. Collection, processing and analysis of samples are also described.
Core Innovation
The invention describes kits, methods, and systems for providing individuals with information about the state of their DNA damage. Specifically, it enables the in-home collection of small blood samples (typically a few drops), which are immediately fixed in a way that preserves DNA break markers for later laboratory analysis. The fixation protocol halts biological activity in blood cells and allows the samples to be reliably shipped and/or stored without altering the signal of interest.
A key challenge addressed is the absence of available systems permitting at-home blood collection for DNA damage assessment. Conventional technologies such as the RABiT system require patients to be physically present at specialized labs and do not account for specific white cell sorting or individual factors like age needed for accurate DNA damage analysis. The invention solves these limitations by providing a service that includes all necessary components for proper sample collection, fixation, shipping, and laboratory processing, thereby enabling remote users to benefit from established DNA damage quantification protocols without laboratory visits.
The invention further details methods for isolating specific leukocyte populations (such as T, B, and NK cells) from the stabilized blood samples, making them amenable to immunofluorescent staining and quantification of DNA damage. Analytical processes include comparison to baseline reference levels and may involve assessment over time for monitoring, as well as data reporting to the individual. The kit and workflow support a broad range of downstream analytical methods for DNA damage, including immunofluorescence and other established laboratory technologies.
Claims Coverage
There are two independent claims in this patent, each outlining distinct main inventive features.
Home-based blood collection kit with stabilizing fixative for DNA damage assessment
A home collection kit comprising: - A sterile lancet for blood collection. - A capillary blood collection device coated with an anti-coagulant to prevent coagulation. - One or more sample tubes, each pre-filled with a fixative, anti-coagulant, and buffer that maintain fixation conditions so the blood can be shipped and/or stored without changes to DNA break markers. This kit allows subjects to self-collect blood samples at home, immediately fix DNA damage signals, and preserve sample integrity during shipping or storage.
Laboratory processing including targeted leukocyte isolation and immunofluorescent DNA damage scoring
After receiving blood samples fixed via the home kit, the laboratory process entails: 1. Isolating T, B, and/or NK cells by: - Hypotonic lysis of erythrocytes in fixed blood samples. - Capturing target cells with CD-specific antibodies. - Coupling antibody-captured cells to magnetic beads or nanoparticles. - Immobilizing cells in a strong magnetic field. - Washing away unwanted cells and serum components, leaving only target cells. 2. Affixing isolated cells to a surface using an adhesive. 3. Labeling cells with primary antibodies for DNA damage markers and fluorescent secondary antibodies. 4. Imaging labeled cells and scoring for DNA breaks. This workflow uniquely enables the quantification of DNA damage in specific immune cell populations from stabilized, home-collected samples.
The independent claims cover an integrated system for home-based blood collection and preservation, along with a specialized laboratory workflow for isolating and analyzing DNA damage in specific blood cell types. The inventive features allow remote DNA damage assessment with stable sample handling and precise, cell-specific analysis.
Stated Advantages
Allows accurate DNA damage analysis from small blood samples collected at home, eliminating the need for laboratory visits.
Maintains stability of DNA damage markers during shipping and storage, ensuring reliable results even after delayed laboratory processing.
Enables specific isolation of white blood cell subtypes, preventing skewed DNA damage measurements due to varying cell ratios.
Supports high-throughput and automated analysis, promoting reproducibility and efficiency in laboratory workflows.
Documented Applications
Assessment of DNA damage risk in relation to diseases such as cancer, age-related diseases, or after exposure to environmental or medical sources of ionizing radiation.
Prediction of subjects’ sensitivity to radiation prior to radiotherapy or medical imaging procedures involving ionizing radiation.
Monitoring of individuals occupationally exposed to radiation or chemicals for workplace safety compliance.
Population screening following environmental exposure events, such as nuclear accidents or chemical contamination incidents.
Evaluation of the impact of lifestyle changes (e.g., diet, exercise, supplements) on DNA damage levels over time.
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