Prostate cancer is the second most common cancer in men. There are an estimated 191,000 new cases and 30,000 deaths per year in the United States.1 The two traditional methods used for early detection of this disease—blood tests to check prostate-specific antigen (PSA) levels and digital rectal exams—have limited effectiveness and present health risks for men. Bio-Techne, which provides life science reagents, instruments, and services to research and life sciences end markets, is working to change this.
The Minneapolis-based company is commercializing a new diagnostic test, the ExoDx™ Prostate IntelliScore test, that is more predictive and less risky for patients than existing methods, helping to better assess the risk of high-grade disease. Through an easy-to-collect urine sample to detect the genetic markers for high-grade prostate cancer, physicians and patients can make a more informed decision on whether or not to pursue a more invasive tissue biopsy. This provides a much more customized and accurate approach to diagnosis and treatment decisions.
A Better Way to Identify Which Patients Need Intervention and When
Primary care physicians (PCPs) are the gatekeepers for the screening, diagnosis, and treatment of prostate cancer patients, but the current tools at PCPs’ disposal are limited. Bio-Techne’s test is intended to eliminate much of the guesswork for PCPs, who typically begin talking to men around the age of 40 about the incidence of prostate cancer and the options to screen for it. The primary tools used to screen for prostate cancer—digital rectal examinations (DRE) and tests of the PSAs in a patient’s blood—have inherent limitations. PSAs are nonspecific biomarkers for prostate cancer, so screening for them can lead to false positives. DRE results, often used in conjunction with the PSA screen, can be subjective based on a physician’s experience and their specialty.
The ExoDx Prostate Test Can Lead to Better Decision-making
The ExoDx Prostate Test is a well-validated urine genomic test that provides important risk assessment data. It can help physicians better determine who is at the greatest risk for high-grade prostate cancer so they need to be referred to a urologist for a prostate biopsy.
The test analyzes prostate gene expression in very small extracellular vesicles called exosomes. These vesicles contain DNA, RNA, and proteins. They are produced and secreted in large quantities from every cell in the body and can be found in urine and other bodily fluids.
The ExoDx Prostate Test is a non-invasive urine test that assesses the risk of aggressive prostate cancer without requiring a digital rectal examination. It analyzes three exosome-located genomic markers that are elevated in high-grade prostate cancer and can eliminate the need for a biopsy in certain cases. Ultimately, the ExoDx Prostate Test can help physicians and their patients make more informed decisions on who may likely benefit, and who might not, from a prostate biopsy.
ExoDx Prostate Test Has Been Validated by Robust Data
The ExoDx Prostate Test has been validated in large-scale clinical studies. It was proven to be significantly more accurate than optimized standard of care models, clinical risk calculators, or PSA tests. The studies have shown the test can help avoid 27 percent of unnecessary biopsies in patients with PSA levels in the gray zone (2–10 ng/mL).2
Use of the ExoDx Prostate Test also resulted in a significant increase in patient compliance with physicians’ biopsy recommendations:
- 92 percent of patients complied with the physician recommendations to defer a biopsy after reviewing results of the ExoDx Prostate Test.
- 72 percent of patients complied with physician recommendations to proceed to a biopsy due to the ExoDx Prostate Test versus 39 percent in the standard care control group.
- 30 percent more cases of clinically significant or high-grade prostate cancer were detected by physicians due to increased compliance, relative to the standard care control group.
Sustainable Development Goals
The Sands Capital six investment criteria tend to lead us to businesses that are innovators or vital facilitators of change in industries undergoing significant transformation. Bio-Techne is one of many portfolio businesses that create impact by addressing at least one major social or environmental challenge identified by the United Nations Sustainable Development Goals (SDGs). Bio-Techne’s efforts support SDG 3: Good Health and Well-Being.
Unless otherwise indicated, all information in this article is drawn from: “The exode™ Prostate Test (EPI) and Primary Care Providers,” A white paper published by exosomdx, a Bio-Techne brand
2 “ExoDx™ Prostate IntelliScore (EPI) A simple urine test for risk assessment of high-grade prostate cancer (HGPCa),” Brochure from clinicians, from Bio-Techne, citing McKiernan J, Donovan M, et al. A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy. JAMA Oncology, July 2016
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