Summary:

The National Cancer Institute (NCI) seeks co-development partners and/or licensees to further develop a novel ELISA-based biodosimeter.

Description of Technology:

Exposure to ionizing radiation or agents that induce DNA double-stranded breaks (DSBs) can result in severe damage to cell and/or tissues, including cell death. This can lead to illness (i.e., acute radiation syndrome, cancer, etc.) or even death.  Identifying the amount of exposure to a DNA DSB-causing agent can be useful in monitoring, determining the need for further testing, and avoidance or modification of certain medical interventions and/or types of medical treatments. DNA damage caused by DSBs can be identified and quantified in situ by detecting phosphorylated histone protein γ-H2AX (gamma-H2AX) foci which is formed at DSBs. However, existing methods of analyzing γ-H2AX are laborious, low-throughput, and prone to variability.

Investigators in NCI’s Developmental Therapeutics Branch have developed a novel, high-throughput ELISA-based biodosimeter to measure DNA damage. This biodosimeter simultaneously quantifies the amount of γ-H2AX and total H2AX and results in a percent γ-H2AX, which is a normalized value representative of the amount of DNA damage. Overall, this biodosimeter provides users with flexibility of input sample type (ex. cells, tissues, blood) and high-throughput, less laborious option to precisely measure DNA damage. It provides reliable, dose-dependent measurement outputs that are independent of variability in cell number, cell viability, cell lysis efficiency, and laboratory operator. Additionally, the biodosimeter is both sensitive and specific, having a 100-fold quantitative range with sensitivity of 5 pM for γ-H2AX and 50 pM for H2AX.

NCI is seeking co-development partners and/or licensees to further develop this novel ELISA-based biodosimeter.

Potential Commercial Applications:

• Assay for measuring DNA damage by a variety of causes (ex. ionizing radiation, environmental agents, chemotherapeutic agents, etc.)
• Biodosimeter to monitor cancer drug treatment course
• High-throughput screening of new drugs targeting DNA metabolism

Competitive Advantages:

• Quantitative
• High sensitivity and selectivity
• Can be used on varying sample types (ex. cells, blood, and or tissues)
• Has internal controls for reliable measurements
• High-throughput and less laborious than other methods for assaying γH2AX levels