MINNEAPOLIS, May 7, 2020 /PRNewswire/ -- Bio-Techne
Corporation (NASDAQ:TECH) today announced a major publication in
the Journal of Prostate Cancer and Prostatic Diseases entitled,
Clinical Utility of the exosome based ExoDx™ Prostate
(IntelliScore) EPI test in men presenting for initial Biopsy with a
PSA 2-10ng/mL (link available here). Principal
investigators Dr. Ronald Tutrone,
Medical Director of Chesapeake Urology, and Dr. James McKiernan, Professor of Urology at
Columbia University, demonstrated the
ExoDx Prostate test, or EPI, delivered improved patient outcomes
over standard of care in a real-world clinical setting that
included 72 urologists, 24 sites and more than 1000 patients.
The study is the first ever prospective, multi-center, randomized
prostate biomarker trial with a blinded control arm conducted in a
clinical utility setting, The study was a collaboration between the
largest urology practice in Maryland, Chesapeake Urology, and CareFirst
Blue Cross Blue Shield of Maryland.
The EPI test is a urine-based genomic test that helps inform the
prostate biopsy decision. This liquid biopsy test recently received
coverage for the VA Healthcare system under the General Services
Administration (GSA) award, received a positive coverage decision
from Medicare, and is included in the National Comprehensive Cancer
Network (NCCN) guidelines for early detection in men for both
initial and repeat biopsy. It is performed by Exosome Diagnostics™,
a Bio-Techne brand, in its CLIA, ISO, and NY certified and
CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk
assessment tool that assists physicians and their patients with
determining if a prostate biopsy is needed when presented with an
ambiguous PSA test result, thereby reducing complications from
unnecessary and invasive procedures.
Key findings from the study include:
- When implementing the ExoDx™ Prostate test in a real-world
clinical setting, patients demonstrated improved compliance with
the physician's recommendation to defer prostate biopsy when the
test was negative and go through with a biopsy when the test was
positive.
- Twenty-three percent of patients deferred a biopsy due to the
EPI test based on the physician-patient shared decision
questionnaire.
- In the standard of care setting, many high-grade prostate
cancers are missed because not all high-risk men go through with a
biopsy.
- Due to improved compliance to proceed to biopsy, physicians
detected 30% more cases of clinically significant, or high-grade
prostate cancer compared to the standard of care control arm.
These findings can have significant implications for both
clinical and economic outcomes. According to Dr.
Ronald Tutrone, "From a clinical
perspective, deferring biopsy can help a patient avoid the
undesirable complications from a biopsy, such as pain, hematuria,
infection and potentially hospitalization. Many patients are
frightened to undergo biopsy procedure; however, introducing an EPI
result not only improved compliance to proceed to biopsy, but
detected more clinically significant cancers that might have been
missed under the standard of care paradigm."
"This study has important implications from an economic
perspective," commented Chuck
Kummeth, President and Chief Executive Officer of
Bio-Techne. "Avoiding unnecessary biopsy procedures represents an
estimated savings to the healthcare system of $1,400-$4,000 per
patient, in addition to added costs treating complications. There
are economic consequences to missing high grade prostate cancer as
well. Risk stratification tools such as the ExoDx Prostate
test provide the right intervention for the right patient at the
right time. Publication of this study in a leading urology
journal confirms our convictions that the ExoDx Prostate test
provides strong clinical utility and economic value to patients,
the medical community and private payors."
A nationwide webinar is scheduled for May
21, 2020 to review the study findings in detail. More
information can be found on the Exosome Diagnostics website at
http://www.exosomedx.com.
About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Senior
Director, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
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SOURCE Bio-Techne Corporation