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Genomic Health, Cleveland Diagnostics Ink Deal to Develop, Commercialize Prostate Cancer Tests

NEW YORK (360Dx) – Genomic Health and Cleveland Diagnostics today announced a licensing agreement to develop and commercialize prostate cancer tests based on Cleveland Diagnostics' IsoPSA reagents and technology.

The strategic collaboration will provide Genomic Health with "broad exclusive global rights" to develop and commercialize early- and late-stage cancer diagnostic tests, the firms said.

Under the agreement, Genomic Health will initially focus on developing a high-PSA reflex test to predict the presence of high-grade cancer, with a Gleason score greater than seven, prior to prostate biopsy.

Genomic Health expects to begin clinical validation of the test in 2018, with the aim of providing initial access to US urology labs in 2020, the firms said.

Cleveland Diagnostics' IsoPSA reagent interrogates the spectrum of structural changes, or isoforms, of complex PSA. Using Cleveland Diagnostics' solvent interaction analysis (SIA) technology, the IsoPSA assay can be integrated into the workflow of urology lab practices to distinguish cancer-related PSA isoforms from benign isoforms, and to detect prostate cancer more precisely than by standard PSA testing alone, the firms said. 

The journal European Urology recently published the results of a Cleveland Clinic-led multi-center prospective trial of the IsoPSA reagent with the SIA technology.

"Our research has shown that IsoPSA offers improved accuracy for identifying men at risk of high-grade disease, which will address one of the main limitations of standard PSA assays by reducing the over-diagnosis of low-grade, indolent cancers," Eric Klein, chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and lead author on the recent study, said in a statement. He noted that use of the IsoPSA assay "is likely to reduce unneeded biopsies for the benefit of both patients and clinicians."

The firms noted that to further confirm this finding, a follow-up multicenter clinical study in more than 250 patients is currently underway and is expected to be completed in the first half of 2018.

As part of their collaboration agreement, Genomic Health will make a $2 million convertible note investment in Cleveland Diagnostics in the fourth quarter of 2017, and it will make a contingent additional payment of $5 million and a $3 million convertible note investment following positive results from the follow-on multicenter study. 

Additional future payments are conditional and will be made as certain milestones are achieved over the next several years, in addition to royalties on test sales, the firms said.

The firms noted that their goal is to reduce unnecessary biopsies and optimize healthcare spending for the more than 4 million screened men who receive a PSA score between 2 and 10 in the US each year.