Renalytix Share Discussion Threads

[wan] 05/6/2023 15:02

It's not often reported on in the UK -

Kidney disease 'could become public health emergency' without more funding, charity warns

Monday 5 June 2023 01:55, UK

NHS 'risks being overwhelmed'

Kidney Research UK said the greater funding could be put towards developing better prevention strategies and treatment options, as well as earlier diagnosis.

Chief executive Sandra Currie said without it, the NHS "risks being overwhelmed with demand".

"There is no cure for kidney disease, a transplant does not last a lifetime and dialysis patients face hours of gruelling treatment every week, taking them away from loved ones and making it harder to work," she added.

"We know the only hope for stopping the growth of kidney disease and the increasing burden to the health system, the economy and to patients is better prevention strategies, earlier diagnosis and better treatment options, and yet kidney disease isn't even included in NHS long-term strategic plans."

A Department of Health and Social Care spokesman said the government is "committed" to improving services for patients living with kidney disease.
Full story Sky News - hTTps://news.sky.com/story/kidney-disease-could-become-public-health-emergency-without-more-funding-charity-warns-12896585

[wan] 31/5/2023 17:05

ckamper...Thanks for the info. Yes, hopefully things are beginning to move in the right direction -

Apparently Georgia is the 10th state to enact similar legislation this month requiring insurance companies in the state to cover the cost of biomarker testing when it is deemed scientifically and medically necessary. Others states are AZ, AR, CA, IL, KY, LA, MD, NM and RI -

ROCKVILLE, Md. (May 4, 2023) - The American Kidney Fund (AKF) applauds Arizona, Arkansas, Georgia, Kentucky and New Mexico for passing legislation that requires health insurance plans to cover biomarker testing for people with chronic diseases, such as kidney disease.
hTTps://www.kidneyfund.org/article/american-kidney-fund-applauds-passage-legislation-requiring-insurance-coverage-biomarker-testing

Renalytix has received criticism from some for not selling many tests into the current long list of signed up health plans, but there is a fact that is appropriately covered in one of your links above -

Congress No Longer Wants to Wait”
Government & Legislative Affairs
May 10, 2023
“Increasingly, medical technology innovators are confronting a ‘valley of death’ where their technologies have received FDA authorization, but often no CMS or insurance coverage is in place to allow patients to gain access to them. Simply put, America’s seniors and patients across the country are all too often not getting timely access to critical medical technologies for many years, if ever.
hTTps://www.advamed.org/industry-updates/news/advamed-to-cms-patients-are-still-waiting-but-were-encouraged-congress-no-longer-wants-to-wait/

So, Renalytix has done a lot of the ground work forming an effective bridge over the valley of death! Plus the deal with EVERSANA will extend and accelerate that progress. Hence the market should 'very much' appreciate FDA approval, which will hopefully come in June.

[ckamper] 31/5/2023 15:44

Many thanks to wan from my side as well.

I am currently thinking about the question of how the hopefully imminent FDA approval will affect the coverage of KidneyIntelX.

Apparently there are efforts in many states, independent of MCIT or TCET, to require FDA-approved biomarkers to be covered by insurers - in some states this is probably already signed into law (?).

See for example:

hxxps://www.precisionmedicineonline.com/precision-oncology/legislation-mandating-insurance-coverage-biomarker-testing-introduced

hxxps://malegislature.gov/Bills/193/S689/Cosponsor

Does anyone know more about this or have an opinion?

Regardless of this, TCET, the successor to MCIT, also seems to be picking up speed just in time.

See for example:
hxxps://www.advamed.org/industry-updates/news/advamed-to-cms-patients-are-still-waiting-but-were-encouraged-congress-no-longer-wants-to-wait/

[wantage] 30/5/2023 11:44

WanMuch appreciate your sleuthing and sharing Renx info. Keep up the good work.

[wan] 25/5/2023 08:26

Todays news is even more encouraging!

With a bias towards the utilisation of AI-driven predictive analytics and cloud-based solutions, and a shared view to improve patient lives, EVERSANA appears to be an excellent choice, especially from a pharmaceutical perspective i.e. Renalytix is not tied to one particular pharma, and therefore potentially has a larger market opportunity, another example would also be SGLT inhibitors coming off patent in the not too distant future.

Keeping the pharma aspect in mind, the following is worth reading to appreciate the deep and vast experience in the successful delivery of commercial expansion, medical technology, and indeed experience and connections within the pharmaceutical industry -
hTTps://www.eversana.com/ourleaders/

That experience and success detailed above includes markets outside of the US, so the partnership may (eventually) be about more than just the US -

"We believe that patients deserve the best options every day in their healthcare journey," said Jim Lang, CEO at EVERSANA. "What Renalytix has created has the potential to impact millions of lives through early-stage preventative care, which will not only make a huge impact on the global healthcare system but most importantly, improve the lives of patients. We could not be more excited to provide our services to support a successful commercialization."

I note the market is not overly impressed at this stage though.

[digger18] 22/5/2023 12:35

Looks like we are getting there slowly but surely. We now need the practitioners to put the patients forward in numbers.

[1jat] 19/5/2023 20:23

Wan…..I am of a similar view…this GM is getting the house in order for a fund raise.
We know one is needed (bar a miraculous explosion in paid for tests)…
The price new funds can be raised at will largely be driven by the FDA opinion….
There is scope for the large investors with an inside track in the fund raise to dilute existing SH on disadvantageous terms….but that does guarantee the funds can be raised quickly and easily (assuming they are onboard).

Now is a very risky time to add as rejection could be a fatal blow…..safer, but perhaps less rewarding to wait for the raise to be announced….and completed.

[wan] 11/5/2023 10:55

My reply on Discord in the US regarding how my post 2159 'might' demonstrate that thought process -

All of the authority to allot shares on a non-pre-emptive basis granted to the Directors at the 2022 AGM was utilised for the purposes of the 2023 Private Placement, which completed on 9 February 2023. The General Meeting is slated for 8 June 2023 and provides the ability to raise funds in the interim of the next AGM. The FDA is working towards a decision date by the end of Q2 2023, so it may be coincidental, but if FDA approval is forthcoming Renalytix will clearly need the flexibility/bridge between June and the end of December (the next AGM) to commence and significantly expanded their commercialisation plans (with or without a partner).

Based on recent interactions with the FDA, while there can be no guarantees, management remains optimistic and is working diligently with the FDA towards a successful outcome. And I don't imagine for one moment that those interactions have ceased!

[wan] 11/5/2023 10:23

I am aware, like others, of the PromarkerD test.

I am of the opinion, that it has not undergone or amassed the same level of real world evidence and clinical utility etc. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary, so it is not in the same league as KidneyIntelx, as KidneyIntelX has received FDA Breakthrough Device Designation and is seeking FDA De Novo marketing authorization.

The PromarkerD test appears to address something very different compared to kidneyIntelx -

Clinical Utility
PromarkerD enables a more comprehensive assessment and informed approach to help:
Identify patients with type 2 diabetes at-risk of developing DKD within the next four years
Implement preventative measures before kidney damage occurs
Personalize patient treatment plans
Improve patient monitoring and management

Whereas KidneyIntelX is designed to provide primary care doctors with a test to risk assess rapid progressive decline in kidney function in adult patients with type 2 diabetes and chronic kidney disease stages 1-3b. This allows PCPs to identify risk early enough to improve kidney outcomes and promote and improve overall patient health.

[ckamper] 11/5/2023 09:53

Do you have an opinion on this? Do you think that the Proteomics International test is a serious competitor?

Sonic Healthcare USA Licenses Proteomics International Kidney Disease Test

May 10, 2023

NEW YORK – Australian diagnostics firm Proteomics International Laboratories announced on Wednesday that Sonic Healthcare USA has exclusively licensed the PromarkerD diabetic kidney disease test for commercialization in the US.

Under the agreement, Sonic Healthcare USA, a division of Australia's Sonic Healthcare, will offer the blood test to physicians and healthcare systems across the US. The assay measures three serum protein biomarkers and three clinical variables — age, HDL cholesterol, and estimated glomerular filtration rate — to predict future kidney function decline in patients with type 2 diabetes, Perth, Australia-based Proteomics International said in a statement. A cloud-based algorithm then combines the results into a patient risk report.

In clinical studies, the test correctly predicted up to 86 percent of otherwise healthy diabetics who developed kidney disease within four years, the company said.

"Our goal of this partnership is to offer PromarkerD as a predictive test that will enable clinicians to identify which patients with type 2 diabetes are at risk of developing kidney disease," Sonic Healthcare USA Chief Medical Officer Mohamed Salama said in a statement. "The PromarkerD test is an important prognostic tool that will substantially advance diagnostic offerings for the diabetic population."

[wan] 11/5/2023 08:23

Interesting timing and the need for the General Meeting. Could that indicate managements increasing confidence regarding the FDA outcome (on or before that date)?

Plus, it demonstrates to potential partners (e.g. Davita and others) that Renalytix have the resources to materially expand commercialisation.

[wan] 10/5/2023 09:42

Interesting commentary from Davita's earnings call for the period ending March 31, 2023.

Excerpt from Q1 2023 Earnings Call
May 08, 2023, 5:00 p.m. ET

On April 1, DaVita and Medtronic announced the launch of Mozarc Medical, a new independent device company focused exclusively on innovative kidney health technologies. Mozarc's current products and its R&D pipeline ranging from kidney access technologies to advanced home dialysis and acute therapies are intended to improve the overall patient experience and increased access to home-based care. This investment reaffirms our commitment to realizing scale transformation in kidney care and allow us to fuel innovation in partnership with Medtronic, a global leader in healthcare technology. And finally, a note on Integrated Kidney Care, or IKC.

We continue to make progress consistent with our business plan and demonstrate that our model of care is improving the health and well-being of our patients. I'll highlight two examples of this. First, across our IKC program, more than half of our patients achieved an optimal start, which means that patient initiates dialysis treatment at home or appropriate vascular access in place. Optimal starts reduced costly and difficult hospitalization and on average, leads to a reduction in the continuing cost of care in the month and year that follow.

Second, recent data continued to show an encouraging differentiation in hospitalization rates from patients in our IKC program versus our overall patient population. As we continue to scale our IKC business, which is measured by the total dollars of medical spend in our program, we will continue to focus on driving our net saving rate while pursuing a cost-efficient model of care. In summary, looking across our most important operating metrics, we're seeing progress at a faster rate than assumed in our initial forecast. Therefore, we are revising our adjusted operating income range of $1.4 billion to $1.6 billion to a range of $1.475 billion to $1.625 billion and revising our adjusted earnings per share range of $5.45 to $6.95 to a range of $6.20 to $7.30.
Full transcript - hTTps://www.fool.com/earnings/call-transcripts/2023/05/08/davita-dva-q1-2023-earnings-call-transcript/

[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
hTTps://investors.renalytix.com/news-releases/news-release-details/partnership-between-renalytixai-and-davita

[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

hTTps://sciendo.com/article/10.2478/dine-2022-0019

[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
hTTps://renalytix.com/blog/why-are-there-so-many-barriers-to-diagnosing-and-treating-kidney-disease/

[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 - hTTps://casehippo.com/spa/courses/resource/2023-spring-clinical-meetings/event/home/posters/abstracts?abstractId=2531

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 - hTTps://casehippo.com/spa/courses/resource/2023-spring-clinical-meetings/event/home/posters/abstracts?abstractId=2245