GeneNews' Innovative Diagnostic Laboratory J-V Launches

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News Desk 2018
GeneNews' Innovative Diagnostic Laboratory J-V Launches Beckman Coulter's Prostate Health Index (phi) Across U.S.

TORONTO, April 24, 2014 (GLOBE NEWSWIRE) -- GeneNews Limited (TSX: GEN ) ("GeneNews" or the "Company") today announced that its recently formed joint venture, Innovative Diagnostic Laboratory LLP ("IDL"), has added Beckman Coulter Diagnostics' Prostate Health Index (phi) to its menu of advanced cancer assays and has initiated a commercial roll out of this groundbreaking test across the United States.

The phi test is a simple, non-invasive blood test that is three times more specific in detecting prostate cancer 1 than PSA (prostate-specific antigen). While PSA is currently the most widely used screening test for prostate cancer, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present. 

"The PSA test is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer," said William Catalona, MD, urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Dr. Catalona, who was the first physician in the U.S. to run the phi test added, "The problem is that higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessarily invasive biopsies and an increased potential for patient harm."

The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multi-center clinical study found a 31 percent reduction in unnecessary biopsies due to false-positives as a result of using the phi test(1).  

"The phi test helps physicians distinguish prostate cancer from benign conditions by utilizing three different PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels," said Kevin Slawin, MD, founder of the Vanguard Urologic Institute at Memorial Hermann Medical Group and director of Urology at Memorial Hermann-Texas Medical Center, who performed some of the key research that led to the development of the phi test and who also began using the test in February. "We have seen first-hand how phi is much more accurate and reduces the need for prostate biopsies. And, the fact that phi is a simple blood test has been very appealing to our patients."

"We are excited to be working with an industry leader like Beckman Coulter to make the phi test available to physicians nationwide through IDL," said GeneNews' Executive Chairman, James R. Howard-Tripp. "The phi test is a significant step forward in prostate cancer management and IDL is the first laboratory to offer this test to physicians throughout the U.S."

Mr. Howard-Tripp continued, "GeneNews is committed to helping IDL become a leader in molecular diagnostics and personalized medicine, serving as a strong commercialization outlet for advanced cancer tests like ColonSentry®, EarlyCDT® Lung and phi. As always, we look forward to updating our stakeholders as IDL grows."

1. Beckman Coulter U.S. Prostate Cancer Pivotal Study Report

About GeneNews

GeneNews is a company focused on developing and commercializing proprietary molecular diagnostic tests for the early detection of diseases and personalized health management, with a primary focus on cancer-related indications. GeneNews' first product, ColonSentry®, is the world's first blood test to assess an individual's current risk for colorectal cancer. GeneNews' common shares trade on the Toronto Stock Exchange under the symbol 'GEN'. More information on GeneNews and IDL, can be found at www.GeneNews.com and www.myinnovativelab.com .  

Forward-Looking Statements

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

Company Contact: James R. Howard-Tripp Executive Chairman Office: (905) 739-2030 Investor & Media Contact: Stephen Kilmer Kilmer Lucas Inc. Office: (212) 618-6347 Mobile: (905) 906-6908

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