- Results of an international multi-center study to evaluate the
accuracy of the ClarityDX Prostate screening test are now available
to the public
- Open access article published in npj Digital Medicine.
Click the link for full-text article: https://rdcu.be/dLqzD
EDMONTON, AB, June 26,
2024 /PRNewswire/ - Nanostics Inc., a precision
health company developing diagnostic tests with its ClarityDX®
platform technology, is thrilled to announce the publication of the
research supporting the development of the ClarityDX Prostate test.
This test combines an optimized machine learning platform with
blood-based biomarkers for clinically significant prostate cancer
and clinical biomarker data to generate the patient's risk score
for clinically significant (defined as Grade Group 2 and above)
prostate cancer.
"Now that the results have been published in Nature Digital
Medicine, scientists, physicians and patients can all evaluate the
scientific evidence for the performance of ClarityDX Prostate as an
adjunctive screening tool for prostate cancer," said Dr.
John Lewis, CEO of Nanostics and
Bird Dogs Chair of Translational Oncology at the University of Alberta.
Early detection and treatment of clinically
significant prostate cancer is key to survivability.
Currently, men are screened for prostate cancer using the PSA test.
However, using the PSA test alone could result in many men
undergoing prostate biopsies when they have no, or low-risk
prostate cancer, and undergoing unnecessary treatments when they
have low-risk cancer. North American and European urology
associations now recommend that men with elevated PSA levels use
adjunctive tests to better inform their decision to biopsy or
not.
According to the 3448-patient study titled, "Development of an
effective predictive screening tool for prostate cancer using
the ClarityDX machine learning platform", validation of
ClarityDX Prostate showed it to have 95% sensitivity, 35%
specificity, 54% positive predictive value, and 91% negative
predictive value for predicting clinically
significant prostate cancer. Using ClarityDX Prostate could
avoid up to 35% of unnecessary prostate biopsies.
The study also compared ClarityDX Prostate to other
model-based risk calculators and PSA alone showing that ClarityDX
Prostate was three times more accurate at predicting the risk of
clinically significant prostate cancer. The study supports the use
of ClarityDX Prostate as an adjunctive test for men with elevated
PSA levels to help patients and their healthcare providers decide
if a prostate biopsy is necessary.
"This study shows that ClarityDX Prostate is accurate at
predicting if the patient has grade group 2 and above prostate
cancer," said Dr. Eric Hyndman,
Urologist and Chief Medical Officer at Nanostics. "Using this as an
adjunctive test after PSA screening will give physicians more
information to help decide if their patient should undergo a
prostate biopsy or not."
This study was supported by funding from the Alberta Cancer
Foundation, Bird Dogs, NRC-IRAP, Alberta Innovates, Ride for Dad
and the Prostate Cancer Fight Foundation, and Prostate Cancer
Canada.
Go to www.nanosticsdx.com for more information and to order
ClarityDX Prostate. Please direct all inquiries about the ClarityDX
Prostate test to Nanostics via email at info@nanosticsdx.com or
telephone 1-800-672-2027.
About Nanostics Inc.
Nanostics is a private Canadian company that develops and
commercializes novel and noninvasive diagnostic tests. Its core
technology, ClarityDX®, uses advanced machine learning algorithms
to create a disease risk score. ClarityDX is applicable to a wide
range of cancers and other diseases. Nanostics' lead product,
ClarityDX Prostate®, is a test that improves the accuracy of
detecting clinically significant prostate cancer. Read more at:
www.nanosticsdx.com. Follow Nanostics on LinkedIn, YouTube,
Facebook, and Instagram.
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SOURCE Nanostics