FDA-Approved Tests
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.
- 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., PAVmed.
- 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. Approved 2016. Zhen Zhang, Ph.D. and Daniel Chan, Ph.D., Vermillion.
- %[-2]proPSA Reduce the number of unnecessary initial biopsies during prostate cancer screening. Approved 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. Approved 2012. John Wei, M.D., Gen-Probe.
- Risk of Ovarian Malignancy (ROMA) algorithm. Prediction of ovarian cancer risk in women with pelvic mass. Approved 2011. Steve Skates, Ph.D., Fujirebio Diagnostics.
- DCP and AFP-L3; a combined panel of biomarkers. Risk assessment for development of hepatocellular carcinoma. Approved 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. Approved 2009. Daniel Chan, Ph.D. and Zhen Zhang, Ph.D., Vermillion.
Purpose of the APOA2-ITQ Test
| Biomarker Assay | Purpose | Year of Approval | EDRN Associate Member/Industrial Partner |
|---|---|---|---|
APOA2-itQ® (analysis of two APOA2 isoforms, APOA2-AT and APOA2-TQ) |
Diagnostic aid for pancreatic cancer |
June 8, 2023; IVD in Japan |
Kazufumi Honda, D.D.S., Ph.D., and Giman Jung, Ph.D /Toray Industries, Inc. |
- Approval in Japan information
- Insurance coverage information: February 1, 2024
- EDRN Reference Set Data, in part, were used in Regulatory Approval Submission