SOLICITATION NOTICE
B -- Genetic Tests upon rare skin disorders and immunologic diseases
- Notice Date
- 3/9/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
- ZIP Code
- 20892-7663
- Solicitation Number
- 263-2006--p--(DQ)-0028
- Response Due
- 3/24/2006
- Description
- The National Institutes of Health, Office of the Director (NIH, OD). The Ordering Office has identified Gene DX, Inc., 9700 Great Seneca Hgwy Ste 200, Rockville, Maryland, to be the only known source to meet the subject requirement. The OD has a requirement for genetic testing to be performed for rare skin disorders. The Office of Rare Diseases (ORD) established the Collaboration, Education, and Test Translation Program for Rare Genetic Diseases, a program that promotes new genetic test development and access to clinical laboratories for the public. The Service is Commercially Available. The following information may be entered into a notice of intent synopsis for a noncompetitive (sole source) acquisition: 1. The period of performance shall be one year from the date of award. 2. The Contractor shall be clinical laboratory improvement amendments (CLIA) certified. 3. The contractor shall have at least 25 years of experience in clinical, ctyogenetic, an molecular genetics research. 4. The Contractor shall provide employees that hold doctorate degrees, masters degrees, be Board-Certified by the American board of Medical Genetics (AMBMG), and be a Board Certified genetic counselor by the American Board of Genetic Counseling (ABGC). 5. The contractor shall have at least twenty five (25) years experience in the development and applications of molecular biological techniques to answer questions about genetics and epidermal differentiation. 6. The contractor shall offer testing in more than one hundred (100) different rare disorders. 7. The Contractor?s test shall be based on bi-directional sequence analysis, with confirmation of identified mutations done using restriction digest, heteroduplex, or other methods. 8. The Contractor?s tests shall include X-linked and autosomal hypohidrotic ectodermal dysplasia, Clouston syndrome, ectrodactyly-ectoderma dysplasia-clefting and related syndromes, lamellar ichthyosis, type 1 and 2, Harlequin ichthyosis (ABCA12), and congenital resessive ichthyosis. 9. The Contractor shall provide a genetic counselor to assist in the development of educational materials for the healthcare provider and, if necessary, the patient and family, to ensure a through understanding of the procedures, findings, and limitations. 10. The Contractor shall develop four to six tests within one year after award. 11. Once the test s are available to the public, the laboratory shall provide structured feedback to ORD about the use of each test for five years. 12. The Contractor shall outline procedures to develop the test and educational materials for the clinical domain. 13. The Contractor shall outline quality control procedures including eradication of false positives and false negatives. 14. The Contractor shall develop the test for clinical application and associated educational materials. 15. The Contractor shall develop a report mechanism and report five years to the office of Rare Diseases: The number of tests undertaken for each rare genetic rare condition. Who requested the test. What queries the laboratory received on the understandability of the test. Who had questions about the test and/or test results (e.g.. Healthcare provider or patient/family). What kind of questions were asked. Any other information that would be helpful to know for ORD to improve the future process of developing tests for rare genetic diseases. 16. The contractor shall identify the need and content for additional or different educational materials. The period of performance shall be one year from the date of award. It is the Governments belief that these requirements may only be met by Gene DX, inc. Thus is not a formal solicitation, however, concerns that respond to this notice must furnish concise responses directed specifically to the requirements mentioned above. Sources demonstrating the capability to accomplish the above shall supply pertinent information in sufficient detail to demonstrate their ability to perform. Information furnished shall include enough material to perform a proper evaluation. Respondents will not be notified of the evaluation results.
- Record
- SN01003013-W 20060311/060309211846 (fbodaily.com)
- Source
-
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