Renalytix Share Discussion Threads

[wan] 25/4/2023 07:40

Yes back in January 2021, which highlights what I said above "But what about CKD stages 1-3b, which KidneyIntelX addresses?". With no reporting on it recently, we have no idea of the status though.

What that partnership appeared to show was that Davita was certainly interested in the earlier stages that they didn't cover.

Early Risk Identification at Core of Innovative Kidney Care Partnership Between RenalytixAI, DaVita
First-of-its-kind program combines early risk assessment of kidney decline and comprehensive care management to help slow kidney disease progression, improve care coordination and reduce costs

[tradertrev] 24/4/2023 16:09

Don't we have a partneship with DaVita?

[wan] 21/4/2023 10:14

In case my reply on Discord in the US might be of some interest to others -

Again, I agree with your assessment regarding a changing landscape, which is heating up. For instance the formation of Mozarc on the 1st April 2023 which is a new company supported by assets and investment between Medtronic, Inc. and DaVita Inc. and according to the details will be dedicated to bringing new technology solutions to patients with kidney failure around the world.

And with regard to Davita inc., a few years ago DaVita Clinical Research (DCR) developed a machine learning algorithm to expand predictive analytics for CKD care apparently enabling clinicians to identify patients with CKD (stages 3–5) at risk of near-term hospitalization. But what about CKD stages 1-3b, which KidneyIntelX addresses (utilising proprietary biomarkers)? DaVita states it is committed to offering the right tools, support and care teams to enable physicians to provide optimal patient care............they will of course not be the only ones committed to offering the right tools, cue the recent KidneyIntelX real-world evidence!

[mrmarmalade] 21/4/2023 05:35

Hi Wan...I really appreciate the work you put in here keeping us informed good or bad. I was wondering if there was a Telegram channel for RENX?
BW MM

[wan] 19/4/2023 09:27

In my view, todays news highlights that it probably gives us a window on at least some of the positive evidence if front of the FDA. Readers will note that "More evidence generation on the wider impact of KidneyIntelX implementation in health systems will be forthcoming."

The need for risk stratification in type 2 diabetes and chronic kidney disease: Proposed clinical value of KidneyIntelX

Published Online: 24 Mar 2023
Volume & Issue: Volume 3 (2023) - Issue 1 (March 2023)
Page range: 1 - 9
Received: 28 Jul 2022
Accepted: 07 Oct 2022

[mr roper] 19/4/2023 08:06

Another solid piece of rwe published today.

All eyes on the fda and the test run rate now

[hashertu] 12/4/2023 12:36

wan. Thanks.
Mind boggling sums of money being spent to treat the end state.

[wan] 12/4/2023 10:49

Renalytix launched their latest blog to coincide with the 2023 National Kidney Foundation’s Spring Clinical Meeting in Austin.

Among other things, they discuss why kidney disease is still not keeping pace with other chronic diseases relative to diagnosis and treatment and the importance (and relatively simple implementation) of early-stage screening, especially in high-risk populations.

An important and informative read that's well worth reading -

Why are there so many barriers to
diagnosing and treating kidney disease?
By Elise Wilfinger
11th April 2023

[wan] 12/4/2023 10:19

Given the results from testing on novel medication prescription in a diverse patient population and the subsequent increased use of SGLT2i's(in accordance with guideline recommendations), a rational question might be, what key player/manufacturer of Sodium-Dependent Glucose Co-Transporter 2 (SGLT2), 'wouldn't', subject to FDA approval, want to recommend or partner with KidneyIntelX version 1 (other tests are in the pipeline, which might also be of interest to partners)?

For context: Janssen Pharmaceutical, Eli Lilly, AstraZeneca Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals are the major companies operating in North America Sodium-Dependent Glucose Co-Transporter 2 (SGLT2) Market.

[wan] 12/4/2023 08:44

E Poster details and links -

Impact of KidneyIntelX testing on novel medication prescription in a diverse patient population

Richard Lord1,Jennifer Houlihan1,Terry Williams1,Steve Coca2,Barry Freedman1.
1. Atrium Health Wake Forest, Winston-Salem, NC, United States.
2. Renalytix, New York City, NY, United States.

INTRODUCTION
Use of risk stratification to guide treatment plans and population health initiatives have potential to prevent complications and improve equity. The KidneyIntelXTM bioprognostic test is a multiplex immunoassay of 3 plasma biomarkers combined with 7 clinical variables to generate an individual risk categorization (High, Intermediate or Low) for progressive decline in kidney function over 5 years in diabetic kidney disease (DKD). KidneyIntelX was recently introduced into the Wake Forest-Atrium Health System to assess early impact on DKD management.

Full details -

Diabetic kidney disease epidemiology in US veterans

Kibum Kim1,2,3,Jacob Crook2,3,Chao-Chin Lu2,3,Heather Nyman2,Joanne LaFleur2,3.
1. University of Illinois Chicago, Chicago, IL, United States.
2. University of Utah, Salt Lake City, UT, United States.
3. Salt Lake City VA Healthcare System, Salt Lake City, UT, United States.

INTRODUCTION
Chronic kidney disease (CKD) carries a significant burden on the Veteran’s Health Administration, with annual costs of $18 billion.[1] Because type 2 diabetes (T2D) is a leading cause of CKD, contemporary epidemiology of diabetic kidney disease (DKD) is essential to define the gaps in current DKD management. Progressive decline in kidney function (PDKF) is a predicted signal for early intervention.[2] We summarized the epidemiology of DKD in US veterans and examined the PDKF as a predictive indicator for early intervention.

Full details -

[wan] 12/4/2023 07:55

More supportive data announced today and being presented at a major conference also bodes well in my view for FDA approval, which is currently under review and active FDA discussion.

[wan] 03/4/2023 08:00

edit to the above post: not to mention a steep (and long!) learning curve and in-depth experience with the FDA.

[wan] 03/4/2023 07:53

Yes, and as I previously remarked, a catalyst for a steep increase in the testing run rate would be partnering with a large diagnostic player, Dialysis player (Davita?), and/or large pharma. In my view it is likely that two or all of those will occur due to KindneyIntelX having a meaningful impact on a market that is too large for those entities to ignore! Such partnering would also negate not only funding requirements, but also the salesforce requirement.

As an additional attraction, in what is obviously a world where AI is increasingly being deployed/integrated, I also see Renalytix expertise in AI & ML development and integration (also beyond kidney disease), not to mention a steep (and long!) learning curve and in-depth experience with the FDA, being of interest to those potential partners too.

[wan] 01/4/2023 12:20

Just in case some readers hadn't seen/heard the answer to a Renalytix question that was put to EKF management during the Q&A section of their Preliminary Results Presentation, which provides an informed and very positive view on the recent FDA update at 33m:39secs in -

[mikemine1] 01/4/2023 12:04

If they get paid $950 for each test that equates to $1,425,000 which could be around $7-8mn for the year depending on how well the sales grow.If it really takes off the $10mn plus could be on the cards but they would need to go some to reach that figure I reckon.

Just speculation on my part of course.

[mr roper] 31/3/2023 09:12

Interesting investor call.

Fda response due in q2.

CEO describes 2023 as "crossing the rubicon". Sinai switching to full commercial contract and seeing payments coming in from diversified sources.

Tests were 1500 for last quarter, by q4 I'd hope that would be doubled to 3000.

Exciting times

[wan] 30/3/2023 09:57

A broadly positive Half-year Report today, with very encouraging indications that testing adoption and testing volumes is set to materially increase.

Obviously Renalytix gave an business update recently (27 March 2023) highlighting further expansion of insurance coverage base for KidneyIntelX, and I also noted on here back in January that according the KindneyIntelx website the coverage for Commercial Health Plans and PPO Networks now extends to 32(possibly more).

I note that coverage has now increased to 36 -

[angus17] 22/3/2023 08:59

Oh ok. I can but hope. Buying a few more today anyway. I like the fact it's below the placing price.

[wan] 22/3/2023 07:56

Not really, as it's standard text from Renalytix for their notice of results.

[angus17] 22/3/2023 07:46

results next week to discuss new partnerships and strategic direction. Do you think we will be hearing about these sometime between now and next week?

A good time to top up I wonder.

[angus17] 21/3/2023 15:26

what we need to give this a boost is a trading update so that we can see what sales are doing. It's a dramatic fall the share price has had in a few weeks and I guess the BOD will be desperate to get it above the recent placing price. I am hoping that those that bought in at the recent placing price have been told that some good news is pending.

[hashertu] 21/3/2023 11:12

hxxps://www.rimsys.io/blog/de-novo-classification-process-a-beginners-guide

wan. This source is marginally easier to read.
Let's hope that delay is nothing more than that.

[wan] 21/3/2023 09:28

Todays RNS can be read several ways, it would thus be good to get further clarification. To my mind/interpretation, the following appears to be the most relevant/likely case as to what is happening -

Reclassification Process Described in Section 513(f)(3) of the FD&C Act
Devices that were not available on the market before the enactment of the Medical Device Amendments to the FD&C Act, on May 28, 1976 (generally referred to as postamendments devices), are automatically classified into class III under section 513(f)(1), without any FDA rulemaking process and regardless of the risks they pose.

Under section 513(f)(3) of the FD&C Act, the reclassification of these devices may be initiated by the FDA itself or it may be in response to a petition from a manufacturer or importer. As with the 513(e) reclassification process described above, to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. If the FDA receives a petition requesting a reclassification, it may ask a device classification panel to review the information and make a recommendation on the petition. After all information is considered, the FDA will issue an order approving or denying the petition. If the FDA approves the petition, the order will describe the reasons for reclassification and identify the risks to health (if any) presented by the device type.

[wan] 17/3/2023 07:58

Renalytix

Join us for a discussion with Dr. Joseph Vassalotti on March 30th at 5:30pmET. It is a rare opportunity to hear directly from the Chief Medical Officer of National Kidney Foundation with the latest evidence on the importance of early risk assessment in chronic kidney disease. Register today!

Diabetic Kidney Disease: Importance of Diagnosis and Early Risk Assessment for Optimal Outcomes

Thu, Mar 30, 2023 10:30 PM - 11:15 PM BST

Clinicians are faced with multiple barriers to address the complex management needs of patients with chronic diseases, including diabetic kidney disease (DKD). Until recently, treatment options for DKD were limited. Large-scale clinical trials have demonstrated that novel therapeutics, like SGLT-2 inhibitors, can significantly slow progression of kidney disease by 25-40% and reduce the risk of cardiovascular events, heart failure and death.

With new risk assessment tools, clinicians can simply and accurately identify those early-stage patients who are at highest risk for progression to rapid kidney function decline and failure. Implementation of KidneyIntelX in the primary care setting will allow clinicians to optimize the therapeutic management and specialist referrals of patients with early-stage DKD, improving outcomes and quality of life for patients.

Join Dr. Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation (NKF) and Clinical Professor of Medicine, in the Division of Nephrology, at Icahn School of Medicine at Mount Sinai who will share his focus on implementation of evidenced-based clinical practice guidelines from the perspective of a practicing nephrologist.