The Long and Winding Road to FDA Approval of a Novel Prostate Cancer Test: Our Story

Author:

Rittenhouse Harry1,Blase Amy2,Shamel Blair3,Schalken Jack4,Groskopf Jack5

Affiliation:

1. IR2DX, San Diego, CA

2. ResMed, San Diego, CA

3. The Shamel Group Incorporated, San Diego, CA

4. Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands

5. Hologic Gen-Probe, San Diego, CA

Publisher

Oxford University Press (OUP)

Subject

Biochemistry (medical),Clinical Biochemistry

Reference16 articles.

1. DD3: a new prostate-specific gene, highly overexpressed in prostate cancer;Bussemakers;Cancer Res,1999

2. DD3PCA3, a very sensitive and specific marker to detect prostate tumors;de Kok;Cancer Res,2002

3. DD3PCA3 RNA analysis in urine – a new perspective for detecting prostate cancer;Tinzl;Eur Urol,2004

4. UPM3, a new molecular urine test for the detection of prostate cancer;Fradet;Urology,2004

5. DD3PCA3-based molecular urine analysis for the diagnosis of prostate cancer;Hessels;Eur Urol,2003

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