SPECIAL NOTICE
A -- NIAAA CRADA Opportunity to Further Develop DNA Melting Analysis Technology for the Detection of Single Nucleotide Polymorphims
- Notice Date
- 5/2/2002
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427 Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Solicitation Number
- Reference-Number-01583
- Response Due
- 6/3/2002
- Archive Date
- 6/18/2002
- Point of Contact
- Patricia Lake, Technology Transfer Specialist, Phone (301) 435-3120, Fax (301) 402-2117, - Patricia Lake, Technology Transfer Specialist, Phone (301) 435-3120, Fax (301) 402-2117,
- E-Mail Address
-
lakep@mail.nih.gov, lakep@mail.nih.gov
- Description
- The Laboratory of Neurogenetics (LNG), National Institute on Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health seeks a CRADA Collaborator. The principal goal of this CRADA is to increase the efficiency and sensitivity of identifying gene variants, including single nucleotide polymorphisms (SNPs). Because SNPs are present in large numbers in human populations (estimated at several million over the entire genome), they are likely to be retained because they are either genetically neutral or they confer survival advantages. However, when combined with other polymorphisms or environmental factors, SNPs may become low-level disease risk factors or disease modifiers. An understanding of functional variations among groups of people is important to medicine for many reasons, including the design of more effective therapeutic drugs and a better understanding of drug side effects, a concept known as pharmacogenetics. DNA melting analysis developed by LNG uses melting of DNA duplexes in solution to detect sequence variants. POTENTIAL AREAS OF APPLICATION: DNA melting analysis is a high throughput approach for detecting sequence variants in DNA. Due to the significance of gene variations in understanding disease progression and in rational drug design, the high throughput approach possible with LNG technology is likely to facilitate studies of therapeutic efficacy. Pharmacogenomics studies have demonstrated that drugs show significant interindividual variation with regard to therapeutic efficacy. Traditionally the effectiveness and safety of a therapeutic drug is based on the results obtained form large clinical trials, which represent the average response of the study group. However, interindividual variation among the study subjects usually shows significant numbers of individuals with little or no response and significant numbers of individuals at the opposite end of the spectrum having dramatic responses. Genetic factors contribute greatly to this variation in responses among groups of people. It is likely that polymorphsims in genes encoding drug targets or enzymes involved in drug metabolism will positively or negatively affect individual drug responses. The potential for more individualized therapy requires a greater understanding of the role of functional polymorphisms associated with drug responsiveness. Thus, the DNA melting analysis technology developed by LNG offers the possibility of the rapid discovery of many more gene polymorphisms with benefit to individualized drug therapeutics. MAIN ADVANTAGES OF TECHNOLOGY/INVENTION: A number of methods rely indirectly on differences in melting temperature to detect gene variants, including SNPs. One indirect method is denaturing gradient gel electrophoresis (DGGE). In DGGE, double-stranded DNAs are moved by an electric field through an increasing gradient of a denaturing agent (e.g. a mixture of urea and formamide) in a gel at constant temperature until they "melt." When the double stranded DNA fragments melt they undergo an abrupt decrease in mobility. DNA melting analysis, as developed by LNG, is a non-gel-based fluorescence method that can detect previously undiscovered sequence variants with high throughput. The method is based on direct measurement of the melting behavior of double stranded DNAs. In addition, the method works for DNA fragments of differing lengths up to approximately 170 base pairs. This method does not require prior knowledge of the SNP (or other variant, such as an insertion or deletion) sequence, does not require expensive oligonucleotide hybridization probes, and does not require modification of the primary sequence (i.e. introduction of a "GC clamp") to a PCR-generated amplicon to detect differences in melting behavior. The method is easily automated using available equipment that permits simultaneous analysis of a large number of samples (for example, 96 samples in a standard 96-well plate). Furthermore, all necessary reagents may be combined in a single step and the melting analysis may be repeated multiple times on a single sample to reduce statistical variation of the data. CURRENT STATE OF DEVELOPMENT: The technology/invention has been described in an article published in the journal Clinical Chemistry, published in March 2001 (Lipsky et al., volume 47, pages 635-644). The National Institutes of Health filed a U.S. provisional patent application. A regular (utility) U.S. patent application is being prepared. FURTHER R&D REQUIRED: Under the present proposal, the overall goal of the CRADA collaboration will involve the following: 1. Further improvement of the technology/invention for high throughput applications including improved efficiency and sensitivity. 2. Developing improved melting parameters for larger PCR-generated DNAs for DNA melting analysis. 3. Developing software to improve variant detection by DNA melting analysis. PARTY CONTRIBUTIONS: THE ROLES OF THE LNG and NIAAA in the CRADA may include, but are not limited to: 1. Providing intellectual, scientific, and technical expertise and experience to the research project. 2. Providing the CRADA Collaborator with information and data relating to the methodology. 3. Publishing research results. 4. Developing additional research applications and/or potential clinical applications. THE ROLES OF THE CRADA COLLABORATOR may include, but are not limited to: 1. Providing significant intellectual, scientific, and technical expertise or experience to the research and development project. 2. Providing programming support for writing novel software, and technical support for writing manuals. 3. Providing technical and/or financial support to accomplish the scientific goals of the project and to further refine applications of the technology as outlined in the agreement. 4. Publishing research results. SELECTION CRITERIA for choosing the CRADA Collaborator may include, but are not limited to: 1. A demonstrated record of success in the development and dissemination of medical or scientific applications. 2. The ability to collaborate with the LNG and NIAAA on further research and development of this technology/invention. This ability will be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to ongoing research and development. 3. The demonstration of adequate resources to perform the research and development of this technology (e.g. facilities, personnel, expertise, and funding) and to accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborator's proposal. 4. The willingness to commit best effort and demonstrated resources to the research and development of this technology, as outlined in the CRADA Collaborator's proposal. 5. The demonstration of expertise in the commercial development and production of products related to this area of technology. 6. The willingness to cooperate with the LNG and NIAAA in the timely publication of research results. 7. The willingness to accept the legal provisions and language of the CRADA with appropriate modifications pertaining to the software component of the technology sought to be developed. These provisions govern the distribution of future rights to intellectual property developed under the CRADA. DATES: Interested parties should notify the Technology Transfer Branch of the NCI in writing of their interest in the CRADA collaboration no later than June 3, 2002. The written notice should briefly address the selection criteria listed above. CRADA proposals submitted thereafter may be considered if a suitable CRADA Collaborator has not been selected. Note that this is not a contract solicitation. NIH will not provide funds to Collaborator for research pursuant to this CRADA, inasmuch as the U.S. Government is prohibited from contributing funds to non-Federal parties under a CRADA, under the Federal Technology Transfer Act of 1986 (15 U.S.C. 3710(a)(d)(1)). CONTACT INFORMATION: Inquires and proposals regarding this opportunity should be addressed to: Patricia Lake Technology Transfer Specialist Technology Transfer Branch, NCI 6120 Executive Boulevard, Suite 450 Rockville, Maryland 20852-7181 301-435-3120 or 301-496-0477 FAX 301-402-2117 e-mail: lakep@mail.nih.gov FURTHER INFORMATION can be obtained from the following web sites: http://ttb.nci.nih.gov/
- Record
- SN00070202-W 20020504/020502213108 (fbodaily.com)
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