Genomic Health will develop and commercialize new prostate cancer tests based on the IsoPSA™ reagents and technology of Cleveland Diagnostics
Genomic Health will develop and commercialize new prostate cancer tests based on the IsoPSA™ reagents and technology of Cleveland Diagnostics

Genomic Health will develop and commercialize new prostate cancer tests based on the IsoPSA™ reagents and technology of Cleveland Diagnostics, through a $10 million-plus collaboration disclosed by the companies.

Under an exclusive licensing agreement, initial efforts will focus on Genomic Health's development of a high- prostate-specific antigen (PSA) reflex test designed to accurately predict the presence of high-grade cancer (Gleason score >7) before prostate biopsy. The test would reduce unnecessary biopsies and optimize healthcare spending, Genomic Health and Cleveland Diagnostics said.

IsoPSA is a reagent designed to interrogate the entire spectrum of complex PSA isoforms—technology that Genomic Health envisions as the basis of an in vitro diagnostic (IVD) blood-based test that it intends to develop and commercialize.

The IsoPSA assay would distinguish cancer-related PSA isoforms from benign isoforms in order to detect prostate cancer more precisely than standard PSA testing alone, according to the companies. The test would also integrate Cleveland Diagnostics' proprietary solvent interaction analysis (SIA) technology platform.

Established in 2013, Cleveland Diagnostics is a portfolio company of Cleveland Clinic Innovations, the commercialization arm of Cleveland Clinic.

A study detailing a multi-center prospective trial of the IsoPSA reagent, including the SIA technology led by Cleveland Clinic, has been published in the December 2017 issue of the journal European Urology.

The study showed the IsoPSA test generated significantly improved diagnostic accuracy over PSA in determining whether a patient has prostate cancer, and identifying patients at risk for high-grade disease. At a cutoff selected to recommend biopsy, the IsoPSA reagent demonstrated a 48% reduction in false-positive biopsies, the study showed. And at a cutoff selected to identity men at low risk of high-grade disease, the false-positive rate was reduced by 45%.

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


Clinical Validation Planned for 2018

Genomic Health—ranked number-two on Clinical OMICs’ list of 20 Molecular Diagnostics Companies to Watch back in February—expects to begin additional development and clinical validation of the first high-PSA reflex test in 2018, the companies said, with the goal of providing initial access to U.S. urology labs in 2020.

“This strategic collaboration marks another important step forward in our mission to address additional unmet needs across the continuum of cancer, by adding a high-PSA reflex test to improve the diagnosis of prostate cancer with greater specificity while eliminating unnecessary biopsies,” Frederic Pla, Ph.D., Genomic Health’s chief business and product development officer, said in a statement. “As we continue to expand our commitment to urology and leverage our commercial capabilities, we will soon have multiple tests to answer critical questions about prostate cancer treatment decisions from early diagnosis to late-stage disease.”

Genomic Health envisions adding the IsoPSA platform to an array of tests that includes the Oncotype DX Genomic Prostate Score™ for low- and intermediate-risk patients considering active surveillance, Oncotype DX AR-V7 Nucleus Detect™ for metastatic patients considering androgen receptor-therapy.

“Tests based on the IsoPSA reagents, with simple workflow and process integration into the lab offered by the SIA technology, promise to satisfy both goals of clinical efficacy and affordability in addressing this important clinical need,” added Cleveland Diagnostics CEO Arnon Chait, Ph.D. “We look forward to collaborating with Genomic Health, a leader in advanced cancer diagnostics, to develop and bring to market a timely test with significant potential to reduce unnecessary procedures, while identifying patients who need further clinical intervention.”

Genomic Health has agreed to make a $2 million convertible note investment in Cleveland Diagnostics during the fourth quarter of 2017, to be followed by an additional $5 million payment and a $3 million convertible note investment, both tied to achieving positive results from the follow-on multicenter study. 

Cleveland Diagnostics would receive additional undisclosed future payments over the next several years, the companies added, based on achieving milestones that include national reimbursement, annual net sales targets and additional licensing rights. Cleveland would also receive royalties on sales of the test.

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