Renalytix Achieves Significant Milestone.
FDA Grants De Novo Marketing Authorization
for kidneyintelX.dkd™, changing how we begin to address
under-recognized kidney disease in adult patients with type 2 diabetes.

Introduction

Readers of this blog know that its intent is to provide the ideas, perspectives and innovations that matter most in kidney health.

Even now, as our test utilizing the KidneyIntelX™ technology, kidneyintelX.dkd, has received De Novo Marketing Authorization by the FDA, our focus remains on how this gets us closer to our goal of eradicating kidney disease. How does this recognition help the 850M who suffer with kidney disease worldwide?

This Special Edition blog explores that very question.

 
So, why is FDA De Novo Marketing Authorization meaningful?

Introduced as part of the U.S. FDA Modernization Act of 1997 (FDAMA), FDA De Novo grants apply to new, low-to-moderate risk technologies that fulfill an unmet healthcare need and are recognized as both novel (first-of-kind) and with no predicate in the market. Further, it establishes a high benchmark and the predicate for all same or like future medical devices reviewed by the FDA.

 
What does that mean for Renalytix and kidneyintelX.dkd™, in particular?

Simply, it means that Renalytix’s kidneyintelX.dkd test is being singularly recognized as the first and only FDA authorized prognostic test that successfully aids early-stage, risk assessment for progressive decline in kidney function. It sets the bar as a predicate for same or like medical devices reviewed by the FDA in the future.

 
Most importantly, what does this mean for clinicians and patients nationwide?

In three words, peace of mind.

It provides clinicians and their patients with a critically important, and proven, new prognostic test that accurately assesses those patients at highest vs lowest risk for progressive decline in kidney function. Therefore, it helps with actionable, segmented patient care.

Although not required for laboratory-developed tests (LDT), Renalytix voluntarily pursued FDA De Novo Marketing Authorization to provide clinicians and patients with the confidence they need and the peace of mind they deserve when defining their precision medicine care plans.

The FDA De Novo pathway requires a stringent review of all data that demonstrates both clinical and analytical performance of the medical device. The FDA reviewed all such data for kidneyintelX.dkd and found that it:

• Demonstrated precision and accuracy in detecting what’s intended, plus reliability in producing repeatable test results;
• Accurately assessed the progression of kidney function decline;
• Had no equivalent test in the marketplace;
• Should be accessible to patients, as quickly as possible.

De Novo Marketing Authorization does not end with a pre-market review and grant from FDA. Rather, it continues with rigorous post-market surveillance and FDA oversight of kidneyintelX.dkd, which we welcome.

 
How does this further advance kidney health in the U.S.?

As the founder and global leader in the new field of bioprognosis™, Renalytix is enabling earlier-stage risk assessment and providing treatment insights that allow patients and clinicians to act sooner — when it matters most.

Imagine a world where we can accurately identify those patients who are at the highest risk for progression of kidney disease? And then customize treatment plans to stem further kidney function decline? That’s exactly what we’re able to do now.

We think about it as the 3 P’s in kidney health care.

Predict. Preempt. Prevent.

• Reliable, consequential predictions that an event will happen in the future (predict who is at highest risk for progressive decline in kidney function).
• To be forward-looking and preempt the worst threats before they emerge (to have a test that course-corrects before the worst kidney disease outcomes occur).
• Prevent future kidney damage through optimized treatment insights and lifestyle behavior changes.

Bringing this new and credible innovation to market will immediately help inform clinicians and guide those patients who live with kidney disease in the United States. In the future, we plan to expand to patients worldwide. All toward our singular goal of eradicating kidney disease.