NEW YORK, Sept. 15, 2020 /PRNewswire-HISPANIC PR WIRE/ — Advocates from kidney organizations around the country will converge virtually on September 16^th for meetings with their Congressional delegations to inspire action for kidney disease at the 7th Annual Kidney Patient Summit. Originally scheduled as an in-person Summit to be held in the nation’s capital last March, due to COVID-19 the event was rescheduled for this week and will be held virtually. The event, led by the National Kidney Foundation (NKF), brings together members of the NKF patient-based Kidney Advocacy Committee and advocates from the Alport Syndrome Foundation, IGA Nephropathy Foundation of America, and PKD Foundation.  As COVID-19 creates more kidney patients, their message is more urgent now than ever.

Advocates representing nearly all 50 states will share their stories and urge their Congressional delegations to support public policy priorities that advance kidney disease prevention, early detection, treatment, research and access to transplants, including living organ donation.  

Actor, activist, and entrepreneur Wilmer Valderrama will lead a virtual briefing for Congressional staff on September 16^th on the impact of kidney disease to Hispanic communities and will meet individually with Members of Congress to stress the importance of policies that promote kidney health. Valderrama is serving as a national spokesperson for the “Are You the 33%?” campaign, which is available in English and in Spanish, and focuses on the 33 percent of adults in the U.S. at risk for developing dangerous, life-threatening kidney disease. Risk factors include diabetes, heart disease, high blood pressure, obesity and family history of kidney disease. Black or African American and Hispanic or Latino people are also at greater risk of developing kidney disease. 

During their individual meetings with Members of Congress and staff, Kidney Patient Summit advocates will specifically be asking policymakers to:

• Pass the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (HR 5534/S.3353) which extends Medicare coverage of immunosuppressive drugs for kidney transplant patients beyond the 36-month cut-off currently in place to cover medications for the life of the transplant;
• Increase funding for kidney disease research and programs including a nationwide Kidney Risk Campaign to reach the undiagnosed who are unaware they are affected by kidney disease. An estimated 37 million adults in the U.S. are affected by kidney disease but 90% are unaware they even have it. Many patients don’t learn they have kidney disease until their kidneys have already failed. Early diagnosis can help stave off the deadly complications of this disease including dialysis and kidney transplant; and
• Pass the Living Donor Protection Act (S. 511 and H.R. 1224), which prohibits insurance companies from denying or limiting life, disability and long-term care insurance to living donors and from charging higher premiums, and also ensures job protections for organ donors who need to take medical leave for organ donation and recovery after surgery.

The Kidney Patient Summit is focused on individuals who have kidney disease, dialysis patients, living donors, family members and caregivers, all united by the affirmation and hashtag “My Kidneys, My Life“ (#MyKidneysMyLife) to underscore the direct relationship between having at least one healthy kidney and living at all. Advocates will emphasize this message during personal meetings with their Congressional delegations on Tuesday, September 16^th.

“I’m continuously inspired by our advocates, who help push for legislation to improve the lives of the 37 million adults in the U.S. living with kidney disease,” said Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant patient. “Each year, the Kidney Patient Summit gives a voice to patients, and those who care for them, as they speak personally to their Congressional delegations to make sure they are not forgotten. This year, more than ever before, we must stress the importance of kidney health and the unique risk and burden kidney patients face with COVID-19. ”

The Summit officially opens Tuesday, September 15^th with virtual training meetings for NKF advocates, their families, and care partners, who will use their collective experiences related to kidney disease to champion NKF’s legislative priorities.  

On Wednesday, September 16^th advocates will attend virtual meetings with Members of Congress and their staffs and will participate in a virtual Congressional briefing, “Kidney Health and the Hispanic Community: Are You the 33%?” from 12:30 to 1:30 pm EST featuring Wilmer Valderrama, Sylvia E. Rosas, MD, MSCE, nephrologist and epidemiologist at the Joslin Diabetes Center and the Beth Israel Deaconess Hospital in Boston, MA, Director of the Latino Kidney Clinic at Joslin Diabetes Center and Associate Professor of Medicine at Harvard Medical School; and patient advocate Maria Grijalva, kidney transplant recipient from California.

Learn more information about the Kidney Patient Summit at advocacy.kidney.org

Kidney Disease Facts
In the United States, 37 million adults are estimated to have chronic kidney disease—and approximately 90 percent don’t know they have it.  1 in 3 adults in the U.S. are at risk for chronic kidney disease.  Risk factors for kidney disease include: diabetes, high blood pressure, heart disease, obesity, and family history. People of Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, or Native Hawaiian or Other Pacific Islander descent are at increased risk for developing the disease. Blacks or African Americans are almost 4 times more likely than White Americans to have kidney failure.  Hispanics are 1.3 times more likely than non-Hispanics to have kidney failure.

The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.

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SOURCE The National Kidney Foundation

NEW YORK, Sept. 14, 2020 /PRNewswire-HISPANIC PR WIRE/ — miR Scientific, LLC announced today that its disease management platform for prostate cancer has been selected as the winner in Questex’s 2020 Fierce Innovation Awards — Life Sciences Edition in the Medical Device Innovation category.  The Fierce Innovation Awards, a peer-reviewed awards program from the publisher of FierceBiotech and FiercePharma, has recognized miR Scientific for the miR Sentinel™ Prostate Test platform as an industry leading medical device innovation.

“Receiving the medical innovation award during National Prostate Cancer Awareness Month from such an extraordinarily accomplished peer-review panel of one of the industry’s leading publishing groups further invigorates our team’s fierce resolve to transform cancer management,” said Sam Salman, Co-Founder and Chairman & CEO at miR Scientific. “Our innovation is a revolutionary validatedⁱ platform that provides a molecular measure of malignancy of the entire organ with unmatched accuracy, and since it is entirely based on a single non-invasive urine specimen, broad accessibility and complete ease of use can be achieved.”

The miR Sentinel™ Prostate Test solves a persistent global real-world problem involving the management of prostate cancer, a screened disease that represents the highest number of new cancer cases diagnosed annually and is the second leading cause of cancer deaths among men worldwide. The current standard of care (SOC) for screening prostate cancer fails to provide subjects and their providers with a definitive indication of the presence of disease and its severity.  As a result, significantly less than half of the age-eligible male population in the US, and even less globally, interact with screening, potentially missing an early detection opportunity that may have likely allowed for successful disease management. The SOC too-often identifies healthy patients as being suspicious of disease, requiring them to be subjected to highly invasive, morbidities-prone and costly core needle biopsies.  Significantly less than half-the men with a suspicion of disease are diagnosed with cancer. The SOC therefore suffers from high false positives, deadly false negatives and systematic health inequity across racial populations.

The miR Sentinel™ Prostate Test is an integrated platform that, from a single urine specimen, 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.  Validation data for the miR Sentinel™  Prostate 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 Company is preparing for the large-scale commercial launch of the miR Sentinel™ Prostate Test as a CLIA and CLEP Lab Developed Test.

The Fierce Innovation Awards highlight companies that demonstrate innovative solutions, technologies and services that have the potential to make the greatest impact for biotech and pharma industries. Winners’ and finalists’ applications were reviewed by an exclusive panel of executives from major biotech and pharma companies. All applications were evaluated based on effectiveness, technical innovation, competitive advantage, financial impact and true innovation. 

Winners were announced in the Fierce Innovation Report Healthcare Edition 2020 published by Fierce Healthcare in September 2020.  

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 miR Sentinel™ PCa Test, which determines whether or not there is molecular evidence of prostate cancer; the miR Sentinel™ CS Test, which for those with a positive miR Sentinel™ PCa Test (or other confirmatory cancer diagnosis), determines whether the cancer is low risk versus intermediate or high risk, and the miR Sentinel™ HG Test, which for those with a positive miR Sentinel™ PCa Test (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 the miR Sentinel™ Prostate Test as 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™, 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 Wang et al, “Expression of Small Noncoding RNAs in Urinary Exosomes Classifies Prostate Cancer into Indolent and Aggressive Disease,” THE JOURNAL OF UROLOGY®, Vol. 204 (September 2020): 466-475. https://doi.org/10.1097/JU.0000000000001020

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SOURCE miR Scientific, LLC