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 |
|---|---|---|
APOA2-iTQ® (analysis of two APOA2 isoforms, APOA2-AT and APOA2-TQ) |
Detection of pancreatic diseases associated with exocrine function disorder (pancreatic cancer, pancreatic cystic neoplasm, pancreatitis, etc.) |
Giman Jung, Ph.D — Toray International America, Inc. |
LungLB |
Blood test validated to detect lung cancer from indeterminate lung nodules |
Paul Pagano, Ph.D. — LungLife AI |
MiCheck (Glypican-1 protein and related signaling molecules) |
Differentiate aggressive prostate cancer from non-aggressive cancer and no cancer |
Daniel Chan, Ph.D. — |
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. — |
Percepta |
(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 |
Detection of pancreatic cancer |
Samir Hanash M.D., Ph.D. — Cosmos Wisdom |
|
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 |
Detection of prostate cancer |
National Institute of Standards and Technology (NIST) — Mitomics |
|
Detection of lung cancer |
William Rom, M.D., M.P.H. — Celera |
|
Detection of lung cancer |
William Rom, M.D., M.P.H. — Somalogic |
|
80-gene panel† |
Detection of lung cancer |
Avrum Spira, M.D., M.Sc. — Allegro/Veracyte |
Detection of colon cancer |
Sanford Markowitz, M.D., Ph.D. — LabCorp |
|
Detection of advanced adenomas and colon cancer |
Robert Bresalier, M.D. — BG Medicine |
|
Risk of hepatocellular carcinoma |
Timothy Block, Ph.D. — Beckman Coulter |
|
Progression prediction of BE |
Stephen Meltzer, M.D. — Diagnovus |