PR85065

NEW YORK, Aug. 10, 2020 /PRNewswire=KYODO JBN/--

-- 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 (https://c212.net/c/link/?t=0&l=en&o=2880549-1&h=163293274&u=https%3A%2F%2Fwww.mirscientific.com%2F&a=miR+Scientific%2C+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 (https://c212.net/c/link/?t=0&l=en&o=2880549-1&h=3761623138&u=https%3A%2F%2Fwww.auajournals.org%2Fdoi%2F10.1097%2FJU.0000000000001020&a=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 - https://mma.prnewswire.com/media/701096/miR_Scientific_Logo.jpg

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

NewYork-Presbyterian/Columbia.

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 (https://c212.net/c/link/?t=0&l=en&o=2880549-1&h=163293274&u=https%3A%2F%2Fwww.mirscientific.com%2F&a=miR+Scientific%2C+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.

(i) https://www.cancer.gov/types/prostate

(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

CONTACT: Media Contact:

         Karen Sharma

         Tel: +1-(617)-571-2733

         pr@mirscientific.com