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.


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. —
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


Liquid biopsy test intended to facilitate clinical decision making in lung cancer

Louise Showe, Ph.D. —


(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


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