CLIA-Approved Markers
Eighteen EDRN developed biomarker tests are available in Clinical Laboratory Improvement Amendments (CLIA) approved laboratories. Eight diagnostic tests or devices supported by the EDRN have also been approved by the U.S. Food and Drug Administration for clinical use.
The CLIA-approved tests are shown in the chart below.
| Biomarker Assay | Purpose |
EDRN Principal Investigator CLIA Laboratory |
|---|---|---|
| MiCheck (Glypican-1 protein and related signaling molecules) | Differentiate aggressive prostate cancer from non-aggressive cancer and no cancer |
Daniel Chan, Ph.D. Minomic, Inc. |
| Videssa (a multi-protein biomarker blood test) | Distinguish benign from malignant breast lesions |
Joshua LaBaer, M.D., and Karen Anderson, M.D. Provista |
| DetermaVu | Liquid biopsy test intended to facilitate clinical decision making in lung cancer |
Louise Showe, Ph.D. OncoCyte |
| Precepta | (23-gene expression panel) Detection of lung cancer |
Avrum Spira, M.D. Veracyte Inc. |
| Esoguard (methylated vimentin and cyclin A1) | Detection of Barrett’s esophagus |
Sandford Markowitz, M.D. PAVmed |
| Decipher Prostate Cancer Classifier Test (SChLAP1 and other lncRNAs) | Determination of prostate cancer aggressiveness |
Arul Chinnaiyan, M.D., Ph.D. GenomeDx |
| Protein panel (TIMP1, LRG1, and CA19-9) | Detection of pancreatic cancer |
Samir Hanash M.D., Ph.D. Cosmos Wisdom |
| Mucin panel (MUC4, MUC5AC, MUC16 and MUC17) | Detection of pancreatic cancer |
Surinder Batra, Ph.D. Sanguine Diagnostic and Therapeutics |
| MiPS (Mi Prostate Score Urine test), Multiplex analysis of TMPRSS2:ERG gene fusion, PCA3, and serum PSA | Detection of prostate cancer |
Arul Chinnaiyan, M.D., Ph.D. Gen-Probe |
| IHC and FISH for TMPRSS2:ERG fusion | Detection of prostate cancer |
Arul Chinnaiyan, M.D., Ph.D. Roche |
| GSTP1 methylation | Decision making regarding repeat biopsies in prostate cancer |
David Sidransky, M.D. OncoMethylome |
| Mitochondrial deletion | Detection of prostate cancer |
National Institute of Standards and Technology (NIST) Mitomics |
| Proteomic panel | Detection of lung cancer |
William Rom, M.D., M.P.H. Celera |
| Aptamer-based markers | Detection of lung cancer |
William Rom, M.D., M.P.H. Somalogic |
|
80-gene panel† †This panel has been refined; Percepta®, a 23-gene classifier, is now available through Veracyte) |
Detection of lung cancer |
Avrum Spira, M.D., M.Sc. Allegro/Veracyte |
| Vimentin methylation in stool | Detection of colon cancer |
Sanford Markowitz, M.D., Ph.D. LabCorp |
| Galectin-3 ligand | Detection of advanced adenomas and colon cancer |
Robert Bresalier, M.D. BG Medicine |
| GP73 | Risk of hepatocellular carcinoma |
Timothy Block, Ph.D. Beckman Coulter |
| 8-gene Panel for Barrett’s Esophagus (BE) | Progression prediction of BE |
Stephen Meltzer, M.D. Diagnovus |