TORONTO, ON / ACCESSWIRE / April 17, 2019 / GeneNews Limited (TSX: GEN) ('GeneNews' or the 'Company'), a life sciences company specializing in blood-based biomarker tests for early cancer detection, has launched the company's first telehealth program for marketing the Prostate Health Index (phi) directly to patients nationwide. The Prostate Health Index is an FDA approved blood test that can help differentiate prostate cancer from benign prostate conditions in men with elevated PSA.¹ Patients can now initiate a physician order online using a telehealth physician network at http://www.mycancerrisk.info/phi.html.

The Prostate Health Index is fast becoming the 'second opinion' for men with elevated PSA who want more information before deciding to move forward with a prostate biopsy. While Prostate Specific Antigen (PSA) is currently the most used screening test for prostate cancer, it is widely recognized that PSA results can indicate the possibility of prostate cancer when none is present. The Prostate Health Index utilizes 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 and can help men and their physicians decide if a prostate biopsy is indicated.²

Addressing an Unmet Need

'We launched this program to address the hundreds of patient inquiries we get for the Prostate Health Index,' commented James Howard-Tripp, GeneNews' Chairman and CEO. 'Men want a greater say in their treatment and want these tests done at their request, timelines and convenience. When you are at risk for having prostate cancer, you want to know what your next step should be. Now, through a telehealth physician network that is familiar with the clinical utility of the test, we have a solution that can address a patient's immediate need to get tested and to help guide their management.'

Studies have shown that approximately 70% of men with an elevated PSA who have a biopsy do not have cancer.³ The Prostate Health Index is included in the National Comprehensive Cancer Network (NCCN) Guideline for Prostate Cancer Early Detection as a blood test to improve specificity for prostate cancer detection.⁴

How it Works

The Prostate Health Index is indicated for men age 50 years and older with an elevated PSA between 4ng/ml and 10ng/ml.⁵ Patients can initiate a request online at http://www.mycancerrisk.info/phi.html. Once an order is submitted, GeneNews will connect the patient with a physician in our U.S. based telehealth partner network who can prescribe the test after confirming the patient is eligible. GeneNews will then connect the patient with a convenient blood draw location or mobile phlebotomist.

The test is processed at GeneNews' CLIA and CAP accredited reference laboratory located in Richmond, Virginia. Results are reported back to the ordering telehealth physician who will review the results with the patient. Patients are advised to share their test report with their regular healthcare professionals so that results can be integrated into their treatment plans.

Patients pay a flat fee of $299 which covers the physician order, blood draw charges, the test and physician consult as required.

About GeneNews Limited

GeneNews is dedicated to developing and commercializing innovative solutions for early cancer detection. Our mission is to provide advanced diagnostics that can help physicians identify cancer in their patients at the earliest possible stage (Stage-0) when it is the most curable. As early pioneers in the liquid biopsy space, GeneNews developed one of the first blood-based biomarker tests for the early identification of Colorectal Cancer. ColonSentry® uses the company's proprietary Sentinel Principle technology, which is based on the scientific observation that circulating blood reflects, in a detectable way, what is occurring throughout the body. Today, more than 100,000 patients in the U.S. have benefited from the ColonSentry test. GeneNews' next generation test, Aristotle®, will use this proven technology to test for ten cancers from a single blood sample. In addition to building a pipeline of products for early cancer detection, GeneNews operates a CAP and CLIA accredited, clinical reference laboratory in Richmond, Virginia that offers the ColonSentry® test as well as licensed biomarker tests for lung, breast and prostate cancers. www.GeneNews.com.

1. Loeb S, Sanda MG, Broyles DL, et al. The Prostate Health Index Selectively Identifies Clinically Significant Prostate Cancer. The Journal of Urology. 2015;193(4):1163-1169
2. White J, Shenoy V, Tutrone RF, et al. Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting. Prostate Cancer and Prostatic Diseases. 2018; 21: 78-84.
3. Biddle C, Brasel A, Underwood W 3rd, et al. Experiences of Uncertainty in Men With an Elevated PSA. Am J Mens Health. 2016;11(1):24-34.
4. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Prostate Cancer Early Detection.
5. Beckman Coulter Access Hybritech p2PSA Instructions for Use.

Company Contact:

James R. Howard-Tripp
Chairman & CEO
jhoward-tripp@genenews.com
Tel. (905) 209-2030

Jerome Cliche
Financial Communication Advisor
​jcliche@genenews.com
Tel. (514) 815-8799

SOURCE: GeneNews Limited