FDA Approved Tests and Devices

Diagnostic tests and devices approved by the Food and Drug Administration.

Eight diagnostic tests or devices supported by the EDRN have been approved by the U.S. Food and Drug Administration for clinical use and 18 EDRN developed biomarker tests are available in Clinical Laboratory Improvement Amendments (CLIA) approved laboratories. Details on the EDRN-supported biomarkers that received FDA approval are listed below.

Biomarker/Device Purpose Year of Approval EDRN Prinicpal Investigators
Industrials Partners
EsoCheck™ Allows patients to undergo a non-invasive five-minute office-based procedure to detect Barrett's Esophagus 2019 FDA-cleared tool Sanford Markowitz, M.D.
CancerSEEK Detection of genetic mutations associated with pancreatic and ovarian cancer. 2019 FDA break through device Ken Kinzler, Ph.D., Robert Schoen, M.D., Randall Brand, M.D., Peter Allen, M.D., and Samir Hanash, M.D.
Thrive Detection Corp.
Overa(5 analytes: CA 125, apolipoprotein A-1, transferrin, follicle-stimulating hormone, human epididymis protein 4) Prediction of ovarian cancer risk in women with adnexal mass. 2016 Zhen Zhang, Ph.D. and Daniel Chan, Ph.D.
%[-2]proPSA Reduce the number of unnecessary initial biopsies during prostate cancer screening. 2012 Daniel Chan, Ph.D.
Beckman Coulter
PCA3 (Prostate Cancer Antigen 3) RNA in urine Determination of need for biopsy or repeat-biopsy in patients at risk for prostate cancer. 2012 John Wei, M.D.
Risk of Ovarian Malignancy (ROMA) algorithm Prediction of ovarian cancer risk in women with pelvic mass. 2011 Steve Skates, Ph.D.
Fujirebio Diagnostics
DCP and AFP-L3; a combined panel of biomarkers Risk assessment for development of hepatocellular carcinoma. 2011 Jorge Marrero, M.D.
Wako Diagnostics
OVA1™ (5 analytes: CA 125, prealbumin, apolipoprotein A-1, beta2 microglobulin, transferrin) Prediction of ovarian cancer risk in women with adnexal mass. 2009 Daniel Chan, Ph.D. and Zhen Zhang, Ph.D.
Version 5.1.0