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264 Novel and Improved Methods for Detecting Epigenetic Modifications
Number of anticipated awards: 2-3
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000
The deadline for receipt of all contract proposals submitted in response to this solicitation is:
5:00 p.m. Eastern Standard Time
Monday, November 3, 2008
Summary:
Epigenetic markers have shown promise for early detection and diagnosis of cancerous lesions. However, it is unlikely that any single epigenetic marker has sufficient sensitivity and specificity to accurately and reliably detect early cancers, or to predict cancer risk and progression. Also, methods used to measure epigenetic modifications need to be improved to increase specificity, sensitivity, reproducibility, and throughput. For example, most methods to measure CpG methylation at specific sites require bisulfite treatment, which is time consuming and can result in incomplete conversion of cytosines to uracils, leading to fluctuations in methylation measurements and poor accuracy. Assays, methods and arrays or chips need to be developed to integrate and improve the ability to detect epigenetic modifications as a non-invasive approach for early cancer detection, risk assessment, diagnosis, prognosis, and clinical response. Responses to this solicitation may include assays for epigenetic modifications such as CpG methylation, histone modification, as well as others.
Project Goals:
The purpose of this initiative is to solicit small businesses to develop innovative and improved assays, methods, or chips for detecting epigenetic modifications applicable for clinical assessment of epigenetic markers of cancer. This SBIR contract solicitation encourages: (1) development of new methods for methylation detection that do not require bisulfite treatment or increase the conversion rate of cytosine to uracil by bisulfite; (2) development of chips for high throughput detection of epigenetic modifications; and (3) development of more sensitive techniques that allow for epigenetic modifications to be measured in small volumes of bodily fluids such as sera or sputum. Most current methods require large volumes, making them unsuitable for use with these bodily fluids and hence for use in early cancer detection and diagnosis.
Phase I activities and expected deliverables:
Develop innovative and improved epigenetic modification detection methods or increase analytical sensitivity to allow for measurement of modifications in low abundance;
- Demonstrate proof of principle for the development of the assay, method or chip;
- Establish a panel of epigenetic cancer markers of interest to be used in testing the assay, method or chip;
- Demonstrate feasibility by testing a panel of 5 to 10 target epigenetic markers;
- Test the usefulness of these methods using DNA extracted from cell lines or clinical samples;
- Obtain input from potential customers and the clinical community in preparation for developing a comprehensive commercialization plan for the assay, method or chip.
Phase II activities and expected deliverables:
Refine and analytically validate the assays, methods, or chips to test accuracy, sensitivity, precision, and dynamic range.
- Provide data comparing the assay, method or chip to previous widely used assays detailing improvements in accuracy, sensitivity, precision, dynamic range, throughput and sample size;
- Use these assays, methods, or chips to characterize more than 30 epigenetic markers;
- Clinically validate the sensitivities and specificities of assays and methods using appropriate clinical samples;
- Generate a scientific publication regarding assay or method performance targeted to the end user audience.
