Dr. Robert H. Getzenberg, a leading University of Pittsburgh and Johns Hopkins cancer researcher who claims to have developed superior new blood tests to detect prostate cancer, colon cancer, and bladder cancer has been accused of making false claims over a period of years and selling these false claims to keep his laboratory working.

Onconome, Inc. a biotechnology company, earlier this month filed an action in Federal court charging that from 2001 to 2005 the University of Pittsburgh and one of its researchers, Dr. Robert H. Getzenberg, committed scientific research fraud and breach of contract.

Dr. Getzenberg has also worked at Johns Hopkins, a leading US center for treatment of prostate cancer and other urological diseases.

Dr. Getzenberg’s best-known scientific project is the EPCA-2 biomarker, a discovery claimed to detect prostate cancer better than the currently used PSA blood test.
In 2007, in a study published in the April issue of the journal Urology, Getzenberg and his team of Hopkins researchers published evidence in support of EPCA-2 testing as a more accurate way to identify cancer in the prostate.
The study claimed to show that EPCA-2 is potentially superior to any biomarker currently in use for detection of prostate cancer. EPCA-2 was judged better than the PSA test at predicting whether a biopsy will show that a man has prostate cancer, simple benign prostatic enlargement (BPH), or a healthy prostate.

According to Onconome, Inc., Dr. Getzenmberg also claimed that EPCA-2 biomarker can distinguish between early stage and late stage, metastatic prostate cancer.

Onconome says that Dr. Getzenberg’s laboratory reports and other statements and claims led them to fund his work “for over five years, spending millions of dollars and devoting virtually its entire anti-cancer effort to the Getzenberg technology.” Onconome says:

Dr. Getzenberg represented to Onconome that the data from his laboratory showed ‘amazing’ results for his immunoassays for prostate and other cancers, and showed the assays were working, reproducible and demonstrated ‘sensitivities’ (meaning few false negatives) and ‘specificities’ (few false positives) approaching 100 percent.

But these representations were false. Dr. Getzenberg misrepresented the research results and data from his lab in order to claim these spectacular results. Even in the last year of his research for Onconome, Dr. Getzenberg’s researchers recorded, in laboratory records that Onconome only recently obtained: ‘the assay didn’t work as expected. . . . Because we don’t have the whole peptide sequence, all of this work may mean nothing'; ‘Everything has fallen apart.. . ; ‘I’m having to throw out samples'; ‘Results A) EPCA 2.22 didn’t work.’

The lawsuit states: “Notwithstanding the spectacular (and false) results proclaimed by defendants, the Getzenberg assay was no more accurate in distinguishing cancerous tissue from normal tissue than flipping a coin.”

Onconome filed suit in Pennsylvania on grounds that Dr. Getzenberg was “employed by and an agent of” the University of Pittsburgh during much of the time covered by the contracts at issue. He was the Director of Urological Research of the Department of Urology, a Co-Director of the Prostate and Urologic Cancer Center of the university’s Cancer Institute, and a Professor of Urology, Pathology, and Pharmacology at the Pittsburgh School of Medicine.

Dr. Getzenberg currently holds the position of Professor and Director of Urology Research in the Department of Pharmacology and Molecular Sciences at Johns Hopkins.

A request to speak with him about the case was answered by an associate at Hopkins who said yesterday that he is in California and will call back, adding: “The charges are not true, Dr. Getzenberg is a wonderful researcher.”

Onconome, a private company based in Redmond, WA, is an in-vitro diagnostics company focusing on the discovery, development and commercialization of innovative biomarkers for the early and accurate detection of various forms of cancer and other major diseases with unmet diagnostic needs. The company lists prostate cancer technology and specifically “IHC tissue test based upon staining of tissue from prostate biopsy samples” among its pipeline projects. IHC, or immunohistochemistry, uses biopsy tissue to develop immune-system antibodies to latch onto and identify specific antigens present in various health conditions ranging from normal to cancer.