Innovation and Partnerships Office

At-Home Test Kit and Lab Analysis for DNA Damage Assessment 2014-044

An at-home blood collection kit that immediately fixes blood cells’ biological activity enabling non-toxic sample shipment or storage without changes in specific DNA markers. Samples are treated and assessed in an automated, high-throughput, reproducible process yielding results that take each patient’s age, health status and exposure history into account.

APPLICATIONS
DNA damage assessment to

  • aid in disease prevention or early detection of disease
  • validate prescribed lifestyle and / or nutrition recommendations over time
  • help monitor protection against oxidation (e.g. when running, when being exposed to ionizing radiation)
  • evaluate ionizing radiation exposure for radiologists, nuclear power plant staff, pilots, astronauts, and others

ADVANTAGES

  • Eliminates need to visit a clinic or lab for blood sample collection
  • Requires only a few drops of blood (10 – 100 μl)
  • Solution in collection tubes immediately halts biological activity in living cells to ensure
    • compatibility with lab testing and
    • non-toxicity for shipping
  • Automated, uniform way to interpret DNA damage in cells yields reproducible results
  • Results take age, health status and other individual factors into account

ABSTRACT

In spite of the public’s growing interest in the effects of DNA damage on human health, and the ability to repair some DNA damage through lifestyle and nutrition choices, there is no at-home blood test for assessing DNA damage and monitoring it over time.

Researchers at Berkeley Lab and Exogen Biotechnology have developed a kit that permits in-home, sterile collection of a small blood sample to be used for DNA damage assessments. Fixation solutions within the kit’s collection tubes preserve blood cell structures and DNA damage markers making cells compatible with lab testing such as cell isolation and immunofluorescent staining. The fixation solution also ensure collected samples are non-toxic to meet shipping regulations.

Once the mailed sample reaches a lab, it undergoes a process to extract and capture nucleated lymphocytes so they can be immunostained for reproducible quantification of DNA damage levels. This isolation of specific white blood cells can be achieved using just a few drops of blood (10 – 100 μl). Cells are then imaged on a high-throughput imaging plate. An automated computer scoring and analysis process compares detected DNA damage levels to a baseline or other reference level based on the age, health status, location, history of toxin exposure,  and other factors affecting DNA. The results can be shared with patients, and further samples collected and tested over time can demonstrate DNA damage level optimization due to corrective changes in lifestyle or nutrition.

A current method for carrying out DNA damage analysis uses high-speed automated image analysis and robotics to examine blood tissue samples quickly for quantitative indicators of radiation exposure. However, analysis of patient samples must be carried out on site. Current available tools have not been tested and refined for physiological levels of DNA damage, do not address sorting specific white cells, and do not take the patient’s age into account for data interpretation – all factors found by the Berkeley Lab / Exogen researchers as required for accurate interpretation of DNA damage levels.

STATUS: Patent pending. Available for license or collaborative research.

DEVELOPMENT STAGE: A prototype test kit has been developed and tested on 97 individuals, clearly establishing age dependence of DNA damage levels.

SEE THESE OTHER BERKELEY LAB TECHNOLOGIES IN THIS FIELD:

Assay to Determine Sensitivity to Radiation, IB-3203

REFERENCE NUMBER: 2014-044