Fresenius Medical Care's Third-Party Clinical Research Organization Frenova Announces Strategic Collaboration Advancing Genomics-Driven, Precision Kidney Disease Care

Rhea-AI Summary

Fresenius Medical Care (NYSE:FMS) announced a strategic collaboration between its research organization Frenova, Nephronomics, and GENEWIZ by Azenta Life Sciences to advance genomic analysis of kidney disease through the My Reason® genomics program.

The collaboration leverages Frenova's registry of over 35,000 participants (targeting 50,000 in two years) to create the world's largest cardio-kidney-metabolic disease database. GENEWIZ will provide DNA sequencing and biospecimen storage, while Nephronomics holds exclusive commercial rights to develop targeted therapies using AI/ML models.

This initiative aims to transform kidney care through personalized medicine by analyzing genetic mechanisms underlying kidney, cardiovascular, and metabolic diseases.

Positive

• Creation of world's largest kidney disease genomic database with over 35,000 participants
• Strategic partnership with leading genomics companies enhances research capabilities
• Potential for development of personalized treatments and improved patient outcomes
• Exclusive commercial rights secured through Nephronomics for therapy development

Negative

• Significant investment required for large-scale genomic sequencing and analysis
• Long development timeline before potential therapeutic applications
• Complex regulatory pathway for precision medicine approvals

• Frenova and Nephronomics, a renal precision company co-founded by Fresenius Medical Care, initiate collaboration with GENEWIZ by Azenta Life Sciences
• Provides vital insights through sophisticated genomic sequencing and analysis of Frenova's My Reason® genomic and clinical data registry
• Paves way for advances in precision kidney disease care, novel therapies, and diagnostics

BAD HOMBURG, Germany, July 31, 2025 /PRNewswire/ -- Fresenius Medical Care today announced that Frenova, the company's third-party clinical research organization, along with Nephronomics, a renal precision medicine company, and GENEWIZ by Azenta Life Sciences, have entered a collaboration to advance the genomic analysis efforts for Frenova's transformative My Reason® genomics research program. This strategic collaboration aims to leverage cutting-edge technologies to better understand kidney, cardiovascular, and metabolic diseases while driving advancements in precision medicine for patients worldwide.

Genomics-driven medicine, also known as personalized medicine or precision medicine, uses an individual's genetic information, specifically their genome, to guide medical decisions. This approach uses genomic analysis to understand a patient's unique biological makeup, enabling more targeted and effective treatments, diagnostics, and preventative strategies.

"Kidney disease affects each individual differently, shaped by their unique biology and genetic makeup," said Frank Maddux, M.D., Global Chief Medical Officer and member of the Management Board at Fresenius Medical Care AG. "These differences influence not only how the disease manifests, but also which treatments and therapies are most effective. By harnessing advanced genetic and molecular insights, we can transform kidney care—making it more personalized, precise, and responsive to each patient's distinct needs. This collaboration paves the way for innovative diagnostics and therapies, enabling truly individualized clinical interventions and redefining what it means to be patient centric."

Frenova's My Reason® genomics research program is a kidney-focused data registry composed of genomic and clinical patient data designed to uncover insights into the genetic mechanisms underlying kidney disease. To date, more than 35,000 participants have been registered in the program and provided biospecimens, with a goal of reaching 50,000 participants over the next two years. The collaboration provides the analysis and gene sequencing necessary to extract the data's rich insights.

"This large-scale whole genome sequencing initiative marks a pivotal milestone in our journey to build the most comprehensive genotype-phenotype database for patients with cardiovascular, kidney, and metabolic diseases," said Jan Walter, President of Frenova. "We are excited to collaborate with Nephronomics on the interrogation of the Nephronomics Atlas to unlock unprecedented insights that could transform patient care."

"The My Reason® dataset, built through Frenova's unparalleled reach and expertise in nephrology care, represents the world's most robust end-stage kidney disease cohort, where many genetic signals are strongest," said James Sietstra, Founder of Nephronomics. "This collaboration will enable us to unlock new insights that not only advance scientific understanding but also translate into genetically informed therapeutics in the cardio-kidney-metabolic field."

"We are thrilled to partner with Frenova and Nephronomics and contribute to the My Reason® research program," said Ginger Zhou, President, GENEWIZ. "This collaboration represents a significant step forward in our shared mission to advance precision medicine and improve outcomes for patients."

Nephronomics holds exclusive commercial rights to the My Reason® dataset, which anchors the Nephronomics Atlas, a resource of deep clinical and genomic cardio-kidney-metabolic (CKM) disease data. Nephronomics aims to develop targeted therapies and redefine CKM disease care through precision medicine insights. By leveraging proprietary artificial intelligence (AI)/machine learning (ML) models trained on this comprehensive dataset, Nephronomics identifies novel disease subtypes, protective genetic variants, and therapeutic targets.

As part of this collaboration, GENEWIZ will apply its validated DNA sequencing technologies and expertise, to generate large-scale genomic data from biospecimens collected through Frenova's extensive nephrology research network. In addition to sequencing, Azenta will also provide long-term storage of samples through its global biorepository network. With over 25 years of experience in DNA sequencing and multiomics analysis, Azenta is uniquely positioned to provide end-to-end solutions for complex research programs.

About Fresenius Medical Care:
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 4.2 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,675 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 299,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

For more information visit the company's website at www.freseniusmedicalcare.com.

About Frenova:
Frenova is a Fresenius Medical Care company that operates as a global Site Management Organization (SMO) dedicated to the management and execution of third-party clinical trials focusing on Cardio-Kidney-Metabolic (CKM) related therapeutic areas. Leveraging our relationship with Fresenius Medical Care's global dialysis clinics and partner nephrology practices, Frenova provides access to a global site network, streamlined procedures, and technology-enabled subject screening and enrollment. Frenova also offers data analytics and licensing services, with access to one of the nephrology industry's largest longitudinal patient databases.

For more information visit the company's website at www.frenova.com.

About Nephronomics:
Nephronomics, a joint venture between Mechanica Partners and Fresenius Medical Care, isassembling the world's largest vertically integrated cardio-kidney-metabolic (CKM) disease database and deep learning model with >35,000 patients consented. The Nephronomics Atlas contains matching whole genome and longitudinal clinical data of patients with advanced CKD and ESKD including comprehensive laboratory data, diagnosis histories, treatments, and raw radiology images.

For more information, please visit www.nephronomics.com.

About Azenta Life Sciences:
Azenta, Inc. (Nasdaq: AZTA) is a leading provider of life sciences solutions worldwide, enabling life science organizations around the world to bring impactful breakthroughs and therapies to market faster. Azenta provides a full suite of reliable cold-chain sample management solutions and multiomics services across areas such as drug development, clinical research and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. Our global team delivers and supports these products and services through our industry-leading brands, including GENEWIZ, FluidX, Ziath, 4titude, Limfinity, Freezer Pro, and Barkey. Azenta is headquartered in Burlington, MA, with operations in North America, Europe, and Asia.

For more information, please visit www.azenta.com.

Disclaimer:
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this release.

Media contact
Kirsten Stratton
T +1 781 929 8096
kirsten.stratton@freseniusmedicalcare.com 

Christine Peters
T +49 160 60 66 770
christine.peters@freseniusmedicalcare.com 

Contact for analysts and investors
Dr. Dominik Heger
T +49 6172 609 2601
dominik.heger@freseniusmedicalcare.com 

www.freseniusmedicalcare.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/fresenius-medical-cares-third-party-clinical-research-organization-frenova-announces-strategic-collaboration-advancing-genomics-driven-precision-kidney-disease-care-302518644.html

SOURCE Fresenius Medical Care Holdings, Inc.

FAQ

What is the goal of Fresenius Medical Care's My Reason® genomics program?

The My Reason® program aims to create a comprehensive kidney-focused data registry of genomic and clinical patient data to understand genetic mechanisms of kidney disease and develop personalized treatments. It currently has over 35,000 participants with a target of 50,000 in two years.

Who are the key partners in FMS's new genomic research collaboration?

The collaboration involves Frenova (FMS's research organization), Nephronomics (a renal precision medicine company), and GENEWIZ by Azenta Life Sciences (providing DNA sequencing and biospecimen storage).

What is Nephronomics' role in the FMS genomics collaboration?

Nephronomics holds exclusive commercial rights to the My Reason® dataset and uses AI/ML models to identify novel disease subtypes, protective genetic variants, and therapeutic targets for cardio-kidney-metabolic diseases.

How will this genomics collaboration benefit kidney disease patients?

The collaboration aims to enable more personalized and precise treatments by understanding patients' genetic makeup, leading to targeted therapies, improved diagnostics, and better preventative strategies for kidney disease.

What is the current scale of Fresenius Medical Care's operations?

Fresenius Medical Care operates 3,675 dialysis clinics worldwide, treating approximately 299,000 patients, and is the world's leading provider of dialysis products and services.