miR Scientific Announces Validation of its Urine Based, Non-Invasive Prostate Cancer Test Published in the Journal of Urology

General News Tuesday August 11, 2020 10:00 —PRNewswire Press Releases

NEW YORK--11 Aug--PRNewswire/InfoQuest

- 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.

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 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).

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