Notice Number: NOT-OD-08-084

Key Dates
Release Date:  July 3, 2008

Issued by
National Institutes of Health, Office of Rare Diseases (ORD), (http://rarediseases.info.nih.gov)

Description

This notice is to inform the research community of a pilot resource program established by the NIH ORD, the Collaboration, Education, and Genetic Test Translation (CETT) Program http://www.cettprogram.org/.  The program was created to facilitate the translation of genetic tests from the research setting to Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.  The CETT Program promotes genetic test translation through collaborations among clinicians, laboratories, researchers, and disease-specific advocacy group.  Researchers play a critical role in the genetic test translation process from a new gene or assay to a clinical diagnostic test utilized in clinical diagnosis and possible care management decisions.  The new CETT funding guidelines further support the researcher’s role in this collaboration.  More information can be found on the CETT Program Web site above or e-mail [email protected].   Through the CETT Program, researchers working on rare diseases can obtain help with forming a relationship with a CLIA-approved laboratory and patient advocate group.  Researchers will be able to:

• Focus their resources on research questions, not on clinical care and service.
• Provide clinical results to their research participants, patients, families through referring clinicians in an approved regulatory manner (follow CLIA regulations for providing clinical information)
• Identify potential new subjects from the expanded access to clinical testing for research participation with documented clinical findings
• Fulfill their commitment to the patient community by bringing research efforts to clinical practice.
• Advance the knowledge base obtained from the collection and storage of clinical data and thereby help move research forward on testing for sand research on genetic rare disease.

Inquiries

Inquiries on the NIH ORD CETT Program can be made by contacting

Giovanna M. Spinella, MD
Program Consultant/CETT Program Director
Office of Rare Diseases, OD, NIH
6100 Executive Blvd., Room 3B01
Bethesda, MD 20892
Phone:  301 402-4336/301 496-0139
Fax:  301 480-9655
E-mail:  [email protected]