Country for PR: United States
Contributor: PR Newswire New York
Monday, August 10 2020 - 21:30
miR Scientific Announces Validation of its Urine Based, Non-Invasive Prostate Cancer Test Published in the Journal of Urology
NEW YORK, Aug. 10, 2020 /PRNewswire-AsiaNet/--

-- Validated Data Reinforces Capability to Molecularly Detect and Characterize 
Prostate Cancer with Concurrent Sensitivity and Specificity of Over 91%

-- Data Support Integration of Sentinel Prostate Test(TM) in Patient Care 
Settings and Decision-Making

-- Adoption Based on Published Data Indicates High Impact to Vastly Improve 
Patient Outcomes and Reduce Unnecessary Interventions and Waste

miR Scientific, LLC ( 
), a healthcare company whose purpose is to transform cancer management by 
providing early and highly accurate detection, characterization and monitoring 
of disease, today announced that validation data for its Sentinel Prostate 
Test(TM) a urine-based, non-invasive cancer test were published in the 
September issue of the Journal of Urology ( 
). These data show that miR Scientific's platform can detect molecular evidence 
of prostate cancer with sensitivity of 94% and specificity of 92%, which 
translates to AUC of 0.98. When the cancer is diagnosed, the test further 
classifies the cancer as either low risk with sensitivity of 93% and 
specificity of 90%, which translates to AUC of 0.98, or critically, as high 
risk with sensitivity of 94% and specificity of 96%, which translates to AUC of 
0.99. The publication highlights test results based on urinary exosomes that 
are isolated from a single specimen of regularly passed urine. Hundreds of 
specifically extracted small non-coding RNAs (sncRNA) are then interrogated in 
a high-throughput real-time PCR–based platform and analyzed with a proprietary 
classification algorithm. 

Logo - 

Prostate cancer is the most common cancer, the second leading cause of cancer 
death among men in the United States, (i) a major source of health inequity, 
(ii) and a massive disease burden borne by individuals, their families, 
strained health systems and payors, including from public, private and 
employer-based sources. Today, despite the dedication and capabilities of 
primary care physicians, urologists and oncologists, patients are primarily 
subjected to a standard-of-care based on the forty-year old PSA test, which 
identifies a significant number of men as having elevated PSA, thereby 
potentially having prostate cancer, even though subsequent, highly invasive 
biopsies will prove that they do not have prostate cancer. Despite the 
variations on the cutoffs, the PSA test often fails to identify aggressive 
disease. (iii) This is a highly significant shortcoming as the patient only 
becomes aware of his cancer at later stages when mortality risk and treatment 
costs are far higher.   

"miR Scientific is dedicated to providing all age-eligible men, especially 
those with suspicion of cancer, a methodologically, clinically and 
scientifically validated technology that provides from a single urine specimen, 
exceptionally accurate, timely and actionable knowledge of the molecular status 
of prostate cancer," said Sam Salman, Chairman & CEO. "Our breakthrough 
platform enables us to reimagine how things ought to be for patients, 
physicians and other key healthcare stakeholders: a standalone test that 
reaches across communities from all racial and socio-economic backgrounds with 
what is demonstrated in the Journal of Urology data to have an unmatched impact 
on comprehensively improved outcomes by optimizing care, reducing anxiety, 
eliminating avoidable morbidities and preserving life and precious financial 
and point-of-care resources."

The publication includes performance data on a case-controlled training and 
validation group of 1,436 subjects comprised of a retrospective sample of 613 
patients from the University Health Network at Princess Margaret Hospital's GU 
BioBank and a cohort of 823 subjects from Albany Medical Center (AMC) and SUNY 
Downstate Medical Center (DMC), where urine samples were collected prior to 
biopsy and analyzed from participants with suspicion of prostate cancer, during 
a 2-year period (2017 to 2019). As further described in the publication, the 
testing and validation group was analyzed with sncRNA sequences obtained from a 
proprietary selection algorithm in a discovery phase comprised of a group of 
235 participants from AMC and DMC. 

"The miR Scientific Sentinel Test(TM) validation data in the Journal of Urology 
significantly contributes to the state-of-the-art innovation capabilities 
available to physicians. The scientists, researchers and biostatisticians 
involved in the creation of this breakthrough platform paid very close 
attention to the needs of physicians whose work always focuses on intervening 
at the earliest possible opportunity to provide life-saving care for patients 
harboring aggressive disease, and improving outcomes and quality of life for 
patients with indolent disease. I am proud to be among a leading cohort of 
physicians who will support the integration of the miR Scientific tests into 
clinical standards and practice," said James McKiernan, MD, the John K. 
Lattimer Professor of Urology, and the chair of the Department of Urology of 
the College of Physicians and Surgeons and urologist-in-chief at 

The potential impact of definitive, accurate detection and classification of 
prostate cancer from a standalone, scalable, and non-invasive urine test is 
profound. With a single test, multiple key points of the traditional patient's 
journey and continuum of care can be transformed into improved outcomes and 
quality of life. From a male population health perspective, the empirical data 
in the Journal of Urology publication supports measurable and sustained 
benefits to key stakeholders when adopted at scale. Applying the data to 
age-appropriate populations, it is expected that as a result of the early 
detection capability of the miR Scientific Sentinel tests, patient treatment 
outcomes shall improve, which often minimizes out-of-pocket costs. Similarly, 
since the publication's data cohort includes the representative population 
found in large employer health plans, covered employees from all ethnicities 
and backgrounds can have the option to benefit from the miR Scientific Sentinel 
Test's demonstrated rapid, reliable, accurate and safe assessment of prostate 
cancer risk and ongoing disease management. The demonstrated high specificity 
and sensitivity indicated in the data support the likely avoidance of wasteful 
costs and lost workdays that are otherwise incurred when unnecessary procedures 
and treatments are given to patients. As also supported by the data, with the 
ability of the miR Scientific Sentinel Test(TM) to identify high risk patients 
from those who do not have prostate cancer, or who have indolent disease, 
hospitals and clinics can benefit from safely prioritizing capacity and medical 
talent for those with high risk disease. Similarly, payors of all types are 
likely to process fewer reimbursement claims for unnecessary procedures and 
associated morbidities, by, for example, making active surveillance a more 
attractive option with a non-invasive test, and mitigating costs of supporting 
late-stage disease interventions. 

Chairman & CEO Salman said that, based on the successful validation of each of 
its three standalone Sentinel test elements, miR Scientific has now taken the 
final step to generate a single, fully integrated Sentinel Prostate Test(TM) 
from a urine specimen collection that definitively classifies and monitors the 
risk of a subject into one of four groups: "No Molecular Evidence of Prostate 
Cancer" (NMEPC), or, for patients with molecular evidence of prostate cancer, 
Low Risk, Intermediate Risk, or High-Risk cancer.

The Company is preparing for the large-scale commercial launch of its Sentinel 
Prostate Test(TM) as a CLIA and CLEP Lab Developed Test.

About the miR Scientific Sentinel Prostate Assay

miR Scientific's published paper in the Journal of Urology makes reference to 
three separately validated tests: the Sentinel PCa Test(TM), which determines 
whether or not there is molecular evidence of prostate cancer; the Sentinel CS 
Test,(TM) which for those with a positive Sentinel PCa Test(TM) (or other 
confirmatory cancer diagnosis), determines whether the cancer is low risk 
versus intermediate or high risk, and the Sentinel HG Test(TM), which for those 
with a positive Sentinel PCa Test(TM) (or other confirmatory cancer diagnosis), 
identifies patients with high grade, high risk cancer. Directly based on the 
validation of three tests in the referenced large Journal of Urology cohort, 
miR Scientific generated a single test that integrates the four possible 
outcomes based on a single urine specimen. The extraordinary sensitivity and 
specificity of the Sentinel tests enable them to be used non-invasively to 
screen, diagnose, prognose and monitor patients with prostate cancer without 
any other adjunctive test or analytic input such as a specific PSA, DRE or 
other value. 

About miR Scientific

miR Scientific, LLC ( 
) is a healthcare company whose purpose is to transform cancer management by 
providing early and highly accurate detection, characterization and monitoring 
of disease. Our team developed the miR Scientific Disease Management 
Platform(TM), which is comprised of proprietary, non-invasive and highly 
accurate liquid biopsy urine tests for the detection, classification and 
monitoring of urological cancers. miR Scientific is a majority-owned operating 
subsidiary of Impact NRS LLC, headquartered in New York with operating 
subsidiaries in Israel, Canada and Puerto Rico.

(ii) Hoffman et al., 2001; Penner et al., 2012; DeSantis et al., 2016, 2019.
(iii) Joseph Presti, Jr. et al., Changes in Prostate Cancer Presentation 
Following the 2012 USPSTF Screening Statement: Observational Study in a 
Multispecialty Group Practice¸ 35(5) J. Gen. Intern. Med. 1368 (Dec. 2019).

SOURCE:  miR Scientific, LLC

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