Applications to the CETT Program MUST be developed and submitted via CETTrack. The Application must be from a CETT Collaborative Group comprised of:

• Clinical Laboratory Improvement Amendments (CLIA)- approved clinical laboratory
• Research laboratory
• Researcher and clinician familiar with the disease
• Disease-specific advocacy group

Andy Faucett, CETT Program Coordinator, is available to help interested parties navigate the application process. For example, if a potential CETT Collaborative Group does not have all the components, the CETT Program Staff can help find a laboratory, connect investigators to a clinical laboratory or to an advocacy group to complete the CETT Collaborative Group, or address other issues throughout the application process.

The CETT Program created CETTrack as an online portal to allow Collaborative Groups to share documents and build their applications. Contact Andy Faucett, CETT Program Coordinator, to register the leader of your Collaborative Group in CETTrack. The leader can then register additional members of the Collaborative Group as they are recruited.

As of June 1, 2008 all applications to the CETT Program must be submitted through CETTrack.

To develop an application, the CETT Collaborative Group should keep the following concepts in mind, as they will be required in the application and test development process.

• Information on clinical uses of the test; how the test results will be interpreted for clinical care providers, patients, and their families; and clinical utility regarding payor reimbursement.
• Methods to collect and store in publicly accessible databases the clinical information on each sample necessary for interpretation, while at the same time respecting confidentiality.
• Methods to collect and store test result information in publicly accessible databases.

• First Friday of the Month - Collaborative Groups must indicate through CETTrack no later than the first Friday of the month that a proposal will be submitted that month.
• Second Friday of the Month - The completed application and all supporting documents must be uploaded into CETTrack. The final version of the application must be “submitted” in CETTrack by midnight EST on the second Friday of the month.
• Documents requiring a signature in which electronic signature is not an option should be priority mailed to:

  Andy Faucett, M.S., C.G.C.
  Emory University School of Medicine
  615 Michael Street, Suite 301
  Atlanta, GA 30322

• The goal of the CETT Program is a 3-month review cycle with updates by Andy Faucett on the status of the application. If a delay is likely, due to unforeseen events and/or requests for additional information, the applicants will be notified by the CETT Program Coordinator.
• An application received off-cycle will be considered in the next month.

Finding an Advocacy Group:

The CETT Program has joined with the Genetic Alliance (GA) and the National Organization for Rare Disorders (NORD) to help applicants find or establish an advocacy group. In addition, the CETT Program assembled a group of experienced advocates (CETT Program Advocacy Mentors) to serve as mentors for Collaborative Groups. These mentors are valuable resources, both for the applicants and for the CETT Program.

Assistance with Educational Materials:

Kate Reed, MS is the CETT Program Education Coordinator. Collaborative Groups should contact Kate via CETTrack as early as possible. Kate can provide examples of effective educational materials and will discuss the plan for development of the educational materials. This step must be completed before the Application is submitted.

Assistance with data collection plans:

The CETT Program has partnered with the National Center for Biotechnology Information (NCBI) to assist each CETT Collaborative Group as they develop a plan to store limited clinical and genotype information necessary to improve the interpretation of the genetic test result and to increase the understanding of the phenotypic spectrum of the rare disease. NCBI is available to assist applicants with the initial design of their collection plan and with the actual organization and storage of genotype and clinical data collected during test translation. The goal of NCBI in working with the CETT Program is to facilitate the development of standard formats and terminology for the collection of clinical information associated with genomic data so that work from many laboratories can be compared. Contact NCBI at cett@ncbi.nlm.nih.gov of via CETTrack to begin this interaction as soon as possible. This contact must be verified in CETTrack before the completed Application is submitted.

Finding a Clinical Laboratory:

The six CLIA-certified members of the National Laboratory Network (NLN), which are experienced in rare genetic disease testing, are willing to become a member of a given CETT Collaborative Group or to work with collaborative groups to help them understand the complexities of rare disease testing and the requirements of the CETT Program application. The NLN laboratories are:

• The Medical Genetics Laboratories at Baylor College of Medicine in Houston
  NLN Liaison: Christine M. Eng, M.D., American Board of Medical Genetics (ABMG)
• Emory Genetics Laboratory in Atlanta
  NLN Liaison: David Ledbetter, Ph.D., Fellow of the American College of Medical Genetics (ACMG)
• GeneDX in Gaithersburg, MD,
  NLN Liaison: Sheri Bale, Ph.D., Fellow of the ACMG
• The Molecular Genetics Laboratory at the Hospital for Sick Children in Toronto
  NLN Liaison: Peter N. Ray, Ph.D., Fellow of the ACMG
• The Orphan Disease Testing Center at the University of California at Los Angeles
  NLN Liaison: Wayne W. Grody, M.D., Ph.D., Fellow of the ACMG
• University of Chicago Genetic Services Laboratories
  NLN Liaison: Soma Das, Ph.D., Fellow of the ACMG

Application page
Application instruction page