EXOSOME DIAGNOSTICS RELEASES INTERIM RESULTS FROM CLINICAL STUDY OF PROSTATE CANCER RISK TEST

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May 18, 2023, 07:00 ET

Halfway through 5-year study, ExoDx Prostate Test offers more accurate stratification of high- and low-risk patients compared to standard of care

MINNEAPOLIS, May 18, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has reported interim results from a previously published prospective, randomized study of more than 1,000 patients aimed at evaluating the clinical utility of the ExoDx™ Prostate Test over a 5-year follow-up period. This study adds to the body of published evidence on the ExoDx Prostate Test. The results came out in a peer-reviewed paper published today in Prostate Cancer and Prostatic Diseases.

In the ongoing study, researchers are assessing clinical outcomes for 1,049 men age 50 or older with a PSA in the gray zone. At the halfway point of this 5-year study, researchers reported that patients identified as low risk by the ExoDx Prostate Test received fewer biopsies, significantly deferred the time to their first biopsy, and were significantly less likely to be diagnosed later with high-grade prostate cancer. Additional biopsies performed over the 2.5 years found additional cancer in both study arms, but the ExoDx Prostate Test arm still found more high-grade prostate cancer (≥GG2) than the standard of care arm.

Prostate cancer is the most common type of cancer found in men, accounting for more than a quarter of all newly diagnosed cancer cases. Early detection is linked to improved survival rates, but typical screening recommendations — such as digital rectal exams or testing for the prostate specific antigen (PSA) biomarker — do not give the full picture. Additional datapoints can aid in risk assessment and identify cases of high-grade prostate cancer that require aggressive treatment.

The ExoDx Prostate Test analyzes key molecular information from exosomes, vesicles that contain full genomic material, and are naturally released from cells and accessible in urine samples. The ExoDx Prostate Test result is independent of the typical data collected in standard of care protocols, offering a new dimension of information to help shed light on prostate cancer risk. The ExoDx Prostate Test was designed to stratify patients with a likelihood of low-grade prostate cancer from those at risk of high-grade prostate cancer. This more accurate assessment enables physicians to understand whether a biopsy procedure is necessary for patients whose PSA results fall into the uncertain "gray zone" for cancer risk.

"For men at very low risk or very high risk of prostate cancer, the standard of care has worked fairly well for ensuring that patients get what they need. Unfortunately, many men fall somewhere in the middle, and our standard of care protocols are not nearly as clear for those cases," said Ronald F. Tutrone, Jr., MD, Chairman of the William E. Kahlert Endowment for Urological Research, Medical Director of Chesapeake Urology Research Associates, and lead author of the paper. "We are excited about the potential for a new approach like the ExoDx Prostate Test to provide more actionable information that could help guide care decisions for so many men who are left behind by conventional screening methods."

Johan Skog, Chief Scientific Officer and Vice President at Exosome Diagnostics and senior author of the paper, commented, "We designed the ExoDx Prostate Test to meet the pressing needs in prostate cancer healthcare today and we are delighted about its performance so far in this important study. As a noninvasive test independent of clinical standard of care datapoints, it can be used safely and easily as a tool for men to potentially avoid the risks of an invasive biopsy procedure without compromising their health."

Paper cited: Tutrone R et al. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer – an interim analysis. Prostate Cancer and Prostatic Diseases. https://doi.org/10.1038/s41391-023-00675-1.

About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000 employees worldwide. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.