CLIA Approved Tests

Tests approved by Clinical Laboratory Improvement Amendments.

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
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