Journey

We’ve demonstrated positive momentum since we opened our doors.

See all archived press releases here.

  • 2Q: 2024
    JUNE:
    • Medicare issues final coverage determination for kidneyintelX.dkd.

  • 1Q: 2024
    MARCH:
    • KidneyIntelX testing technology has been included in the final KDIGO 2024 Clinical Practice Guidelines for the Evaluation and Management of CKD.
    JANUARY:
    • New published data demonstrates that EHR deployment of KidneyIntelX™ was associated with clinical actions that slowed progression of chronic kidney disease and improved Type 2 diabetes control in just 12 months. Results demonstrated a 61% increase in preventative drug prescriptions among patients in the high-risk group and improved specialist referrals which can significantly reduce overall cost of care and improve patient outcomes.

  • 3Q: 2023
    AUGUST:
    • Renalytix Clinical Advisory Board formed with world-leading, multi-disciplinary experts to support broadening adoption and use of FDA-authorized kidneyintelX.dkd.
    JULY:
    • 12 Months KidneyIntelX™ in vitro prognostic testing continued to demonstrate clinical actions that lead to improvement in both diabetes (A1C reductions) and kidney health (eGFR slope improvement) in patients with type 2 diabetes and CKD.

  • 2Q: 2023
    JUNE:
    • FDA grants marketing authorization for kidneyintelX.dkd to assess risk of progressive kidney function decline in adults with type 2 diabetes and early-stage kidney disease.
    MAY:
    • Renalytix selects Eversana to expand commercialization of KidneyIntelX for early-stage kidney disease prognosis detection in patients with type 2 diabetes.
    APRIL:
    • Real-world Utility Data demonstrates KidneyIntelX optimizes clinical management in early-stage CKD across physician specialities.

  • 1Q: 2023
    JANUARY:
    • Renalytix completes agreement with Veterans Administration to integrate KidneyIntelX testing across all Electronic Health Record Systems.
    • Renalytix and Partners awarded $10M Horizon Europe Grant to advance personalized medicine in treating CKD throughout Europe and the U.S.

  • 4Q: 2022
    DECEMBER:
    • Primary care use of KidneyIntelX in early stage CKD improved clinical care delivery and outcomes. First-in-class, bioprognostic™ KidneyIntelX provided clear direction for primary care physicians to slow or stop progression of chronic kidney disease in adult diabetes patients.
    NOVEMBER:
    • Published real world evidence demonstrates KidneyIntelX™ improved clinical decisions and outcomes in high-risk patients with early-stage diabetic kidney disease. Risk scoring by KidneyIntelX resulted in a 4.5-fold increase in new drug prescriptions (for SGLT2i inhibitors) for high risk compared to low risk patients, an observed reduction of HbA1c levels in the highest risk patients, an overall increased use of antihypertensive therapeutics, and an observed early reduction in albumin to creatine ratio levels in the low and intermediate risk groups.
    OCTOBER:
    • KidneyIntelX clinical utility and health economics validated in multiple data releases at American Society of Nephrology. First clinical utility findings with multi-year real world evidence from a major health system was shared. Results underscore the value of the KidneyIntelX™ platform in improving cost economics for the Medicare population.

  • 3Q: 2022
    AUGUST:
    • Data results published in American Journal of Managed Care demonstrate adoption and clinical utility of KidneyIntelX™ with primary care physicians. Clinicians confirmed KidneyIntelX has value as a risk decision tool in their adult patients with type 2 diabetes and chronic kidney disease stages 1-3b.

  • 2Q: 2022
    JUNE:
    • KidneyIntelX™ demonstrates ability to assess risk of heart failure hospitalization and death in large international diabetic kidney disease patient cohort. Data shared in oral presentation at American Diabetes Association 82nd Scientific Sessions® highlights importance in early understanding of cardiovascular risk, a leading cause of death in patients with diabetes and chronic kidney disease.
    • Late-breaking data presented at American Diabetes Association Scientific Sessions® demonstrates increased adherence to care guidelines for physicians using KidneyIntelX risk assessment to improve outcomes, alleviate patient suffering, and reduce significant financial burden associated with progressing chronic kidney disease.

  • 1Q: 2022
    MARCH:
    • Renalytix reaches enrollment milestone for building KidneyIntelX as premier precision medicine platform for kidney disease and diabetes. On track to reach over 30,000 biospecimens with matched electronic health records from multiple centers across the U.S.
    FEBRUARY:
    • KidneyIntelX™ clinical results presented at World Congress of Nephrology demonstrate improved prediction of kidney function over standard of care (UACR and historical eGFR) change over time.
    JANUARY:
    • American Diabetes Association and Renalytix announce partnership and national program to establish early care management, technology innovation and large health system engagement to support the 34 million U.S. individuals living with diabetes.
    • Singing River Health System and Renalytix join forces to improve kidney health on the Mississippi Gulf Coast, focusing on underserved populations with high disease burden.
    • American Journal of Nephrology data demonstrates KidneyIntelX successfully monitors patient response to SGLT2i therapy in 1,325 CANagliflozin CardioVAScular Assessment Study (CANVAS) multinational clinical trial cohort patients.
     
  • 4Q: 2021
    NOVEMBER:
    • St. Joseph’s Health and Renalytix partner to advance value-based kidney health in New York. Partnership expands doctor and patient access to advanced prognosis and coordinated care management of early-stage diabetic kidney disease.

  • 3Q: 2021
    SEPTEMBER:
    • Mount Sinai initiates system-wide scaled-up implementation of KidneyIntelX™ early-stage risk assessment testing and care management program across primary care and specialty clinician networks under a real-world evidence development program for patients with diabetic kidney disease (DKD).
    JULY:
    • Payer budget impact analysis projects significant savings from KidneyIntelX™ testing at primary care level, as published in peer-reviewed publication, Journal of Medical Economics.

  • 2Q: 2021
    JUNE:
    • Utility Study indicates KidneyIntelX risk assessment can address treatment ambiguity in primary care.
    • Renalytix announces new data demonstrating that KidneyIntelX can be effective at monitoring SGLT2i therapeutic response and improvements in kidney health over time in adults with Type 2 diabetes.
    MAY:
    • Renalytix partners with Atrium Health, Wake Forest Baptist Health and Wake Forest School of Medicine to reduce impact of kidney disease in large populations.
    APRIL:
    • Multi-Center Study finds KidneyIntelX 72% more effective than the current standard of care in identifying early-stage patients at higher risk for disease progression and failure.
    • Clinical Utility Study demonstrates that primary care physicians are highly likely to order KidneyIntelX to inform care decisions.
    • Renalytix and Joslin Diabetes Center enter exclusive option agreement for patent filings on select additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelX platform.
    • KidneyIntelX demonstrates performance and informs treatment decisions in multinational CANagliflozin CardioVAScular Assessment Study (CANVAS).
    • U.S. General Services Administration grants 10-year governmentwide contract for KidneyIntelX testing.

  • 1Q: 2021
    FEBRUARY:
    • The University of Utah and Renalytix form partnership to enable health system-wide approach to help delay or prevent kidney disease progression in the earliest stages.
    JANUARY:
    • Renalytix signs multi-geography, U.S. partnership with DaVita, an end-to-end kidney solution.

  • 3Q: 2020
    SEPTEMBER:
    • Renalytix initiates KidneyIntelX Testing at Mount Sinai, with its first live EHR Integration.
    AUGUST:
    • Renalytix announces partnership with Astra-Zeneca, teaming up to improve CKD treatments and outcomes.
    • Renalytix files submission with FDA, seeking clearance of its KidneyIntelX test platform.
    • Renalytix commences with a KidneyIntelX Multi-Center Study to monitor & predict kidney risk in COVID-19 patients.
    JULY:
    • Renalytix raises $85.1M on the NASDAQ Global Market in the U.S.
    • Renalytix signs agreement to become a provider in the America’s Choice Provider Network, one of the largest, preferred networks in the US with members and providers in all 50 states and agreement with 1700+ payers.
     
  • 2Q: 2020
    JUNE:
    • Renalytix is granted a Clinical Laboratory Permit for KidneyIntelX from the NYS Department of Health, following an extensive review by a panel of Department of Health scientists and external reviewers of the analytical and clinical validation results.
    • Renalytix announces partnership with University of Michigan to extend its KidneyIntelX platform to an expanded population of CKD patients or patients at risk for developing CKD.
    MAY:
    • Renalytix proposes dual-listing on NASDAQ.
     
  • 1Q: 2020
    FEBRUARY:
    • Renalytix receives ISO 13485 certification for its Salt Lake City Laboratory.

  • 4Q: 2019
    DECEMBER:
    • Renalytix opens second CLIA-authorized testing facility, Utah.
    OCTOBER:
    • Renalytix obtains a distinct Common Procedural Terminology (CPT) reimbursement code 0105U, for its KidneyIntelX platform, effective across the U.S.

  • 3Q: 2019
    SEPTEMBER:
    • Renalytix achieves inclusion on the Final 2020 Clinical Laboratory Fee Schedule (“CLFS”) with a set national price of $950 per reportable test for its KidneyIntelX test platform (effective January 2020 through December 2022).
    JULY:
    • Renalytix raises gross proceeds in follow-on financing on the AIM market, $17.3M.
    • Renalytix announces positive interim study results conducted with leading academic medical centers in the U.S.

  • 2Q: 2019
    MAY:
    • FDA grants Breakthrough Device Designation to Renalytix for its KidneyIntelX test, identifying it as a breakthrough technology for which no approved or cleared alternative exists and meeting the criteria of providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease.
    APRIL:
    • Renalytix published a manuscript outlining demonstrated performance of its machine learning algorithm which combines biomarkers and EHR data to predict progressing kidney disease.

  • 1Q: 2019
    MARCH:
    • Renalytix requests parallel CMS reimbursement review of KidneyIntelX with the FDA review.
    • Renalytix requests Breakthrough Device Designation of KidneyIntelX from the FDA.

  • 4Q: 2018
    NOVEMBER:
    • Renalytix secures $29.1 million in funding to support the development and commercialization of two product categories for the early detection of kidney disease and accurate management of kidney transplant rejection.