Clinical Services

Translational Trials Development and Support Laboratory (TTDSL)

The Translational Trials Development and Support Laboratory (TTDSL) has been established to provide laboratory services that comply with Good Clinical Practice (GCP), College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) standards. Compliance with these standards assures that the assay results used for decisions in routine clinical settings, study development and for clinical trial participant eligibility and monitoring are reproducible, objective, valid, and reliable.

A listing of assays currently available is provided on the Clinical Sample Submission forms in the Forms Link. The TTDSL has the ability to develop most investigator specific research tests to SOP level assays that meet CAP/CLIA requirements.

The TTDSL assay compendium includes cellular and molecular testing as follows:

  • Endotoxin by LAL
  • Fanconi Anemia Complementation typing
  • Clonogenic assays (+/- presence of drugs) for enumeration and function
  • Clonal contribution studies including vector insertion site analysis and sequencing (LAM PCR)
  • Quantitation of VEGF-D in human serum for Lymphangioleimyomatosis (LAM) diagnosis - Available in EPIC

The laboratory has significant expertise in assays to detect, quantitate, and sequence insertion sites, including molecular detection and tracing of stem cell activity and lineage specific repopulation, surveillance for potential oncogene activation, and other specific molecular safety and efficiency monitoring assays. 

The TTDSL is accredited by the College of American Pathologists (CAP). The accreditation documents that the laboratory not only meets Federal Clinical Laboratory Improvement Amendments (CLIA) requirements, but exceeds them. CAP has the authority of the Centers for Medicare and Medicaid Services (CMS) to accredit all CLIA specialties and subspecialties. CMS is also recognized by The Joint Commision (TJC) as an equivalent program in TJC-accredited institutions. 

The TTDSL holds a Type 5 Master File (BB-MF) that may be used for cross reference in support of IND submissions. Contact us for more information.

Selected References

1.  Chandra S, Levran O, Jurickova I, Maas C, Kapur R, Schindler D, Henry R, Milton K, Batish SD, Cancelas JA, Hanenberg H, Auerbach AD, Williams DA. (2005) A rapid method for retrovirus-mediated identification of complementation groups in Fanconi anemia patients. Mol Ther. 12(5):976-84

 2.  Kelly PF, Radtke S, von Kalle C, Balcik B, Bohn K, Mueller R, Schuesler T, Haren M, Reeves L, Cancelas JA, Leemhuis T, Harris R, Auerbach AD, Smith FO, Davies SM, Williams DA (2007). Stem cell collection and gene transfer in Fanconi anemia. Mol Ther.15(1):211-9

 3.  Zhang X, Shang X, Guo F, Murphy K, Kirby M, Kelly P, Reeves L, Smith FO, Williams DA, Zheng Y, Pang Q (2008). Defective homing is associated with altered Cdc42 activity in cells from patients with Fanconi anemia group A. Blood 112(5):1683-6. Epub 2008 Jun 18

4.  Singh TR, Bakker ST, Agarwal S, Jansen M, Grassman E, Godthelp BC, Ali AM, Du CH, Rooimans MA, Fan Q, Wahengbam K, Steltenpool J, Andreassen PR, Williams DA, Joenje H, de Winter JP and Meetei AR (2009). Impaired FANCD2 monoubiquitination and hypersensitivity to camptothecin uniquely characterize Fanconi anemia complementation group M. Blood 114(1):174-80

5.  Ali AM, Kirby M, Jansen M, Lach FP, Schulte J, Singh TR, Batish SD, Auerbach AD, Williams DA, Meetei AR. (2009) Identification and characterization of mutations in FANCL gene: a second case of Fanconi anemia belonging to FA-L complementation group. Hum Mutat. 30(7):E761-70

6.  Hartmann L, Neveling K, Borkens S, Schneider H, Freund M, Grassman E, Theiss S, Wawer A, Burdach S, Auerbach AD, Schindler D, Hanenberg H, Schaal H. Correct mRNA processing at a mutant TT splice donor in FANCC ameliorates the clinical phenotype in patients and is enhanced by delivery of suppressor U1 snRNAs (2010). Am J Hum Genet. 87(4):480-93