Renalytix Share Discussion Threads

[wan] 15/6/2023 07:58

Very interesting collection of key Presentations announced today at important Scientific Conferences taking place next week.

[wan] 12/6/2023 13:14

My reply on Discord in the US -

You appear to be writing-off that FDA approval will likely provide for catalysts that enables strategic partnerships. For example one would assume that pharma would need a medical device that's utilised to improve guideline-based standard-of-care for optimal utilization of existing and novel therapeutics, such as SGLT2i's (and more), to be FDA approved. I note from the current SEC filing that Renalytix is still recording revenue from the agreement with AstraZeneca -

Recall that Renalytix has stated previously, including in their latest SEC filing, that "As a result of the initial success with AstraZeneca the Company plans to pursue further collaborations with pharmaceutical companies and make ‘Pharmaceutical Services Revenue’ a core part of the business going forward with the goal of improving guideline-based standard-of-care for optimal utilization of existing and novel therapeutics using the KidneyIntelX testing platform and proprietary care management software." Again one assumes that such a pharmaceutical service, guiding the utilization of therapeutics, would be best served/require FDA approval.

Furthermore, FDA approval would be expected to have some advantages. Certain health insurance payors have paid higher amounts over Laboratory Developed Tests (LDT) prices for FDA approved or cleared tests, recognising the additional costs of bringing a test through regulatory review. Some payors also accept FDA approval or clearance as a presumptive evidence of an assay’s analytic validity and clinical validity, which can reduce the barriers to coverage since the payor can focus its review on clinical utility.

From a diagnostics perspective, Renalytix are initially providing KidneyIntelX as a LDT under CLIA in their certified laboratory in Salt Lake City, Utah and through their New York City based laboratory facility. Put another way, “laboratory-developed tests” or “LDTs” are used solely within that laboratory and are not distributed or sold to any other labs or health care facilities to perform on their own. Thus, FDA approval would not limit testing to just those labs i.e. it could be distributed more widely to any appropriately certified lab. Hence, FDA approval could be a catalyst that enables a strategic tie-up with a large diagnostic player

[wan] 10/6/2023 08:24

Aside from sales expansion and its analysis etc, this is where EVERSANA could also come into play (and much more!) - Data Analytics: EVERSANA can help pharmaceutical companies pinpoint areas of high need for SDoH initiatives by stitching together data from various quantitative and qualitative sources, such as Community Health Needs Assessment reports, Community Health Rankings, claims data, prescription data, and other types of data as appropriate. And it's why I said previously that it will also be interesting to see how EVERSANA evolve from a therapeutic perspective regarding diabetic kidney disease.

For source reference of the above and for further insights of the breadth and depth of what EVERSANA can add (including the mention of SGLT2 on page 4) the following document provides much food for thought -

Pharma’s Role in SDoH: There is limited publicly available information on SDoH programs by pharmaceutical companies, which confirms our understanding from conversations with KOLs that pharma has largely been missing from the SDoH discourse. However, within the past few years, more attention is being directed toward SDoH by pharma. Delays in seeking diagnosis or treatment for medical problems are highly correlated to SDoH, as evidenced through multiple research efforts:

[wan] 10/6/2023 08:22

Staying with population health: Excerpts from the earnings call transcript - As we signaled last quarter, we completed the milestone of transitioning to long-term commercial insurance payments for patients tested at the Mount Sinai Health System. During this transition, there was a short-term adverse impact on testing volumes. Importantly, Mount Sinai has this month issued a population health update to all physicians to include the KidneyIntelX testing in the diabetes kidney disease care pathway, based on their newly published KidneyIntelX utility evidence. We expect additional health systems will likely do the same given the important positive results from the growing body of positive real-world evidence.

Two recent studies presented at the National Kidney Foundation Spring Clinical Conference illustrate the following: First, Atrium Health System demonstrated KidneyIntelX testing accurately assesses the higher risk for progression of chronic kidney disease in black patients versus other races. This is an important precursor in addressing health care access inequalities within this patient population. Notably, within Atrium, a KidneyIntelX test result led to increased prescription of SGLT2 inhibitor drug therapy to provide improved care for black patients.

And secondly, as James said, to have population health work with clinical medicine to issue that guideline and bulletin update that incorporates KidneyIntelX into their testing. It's very significant, not only there, but for other health systems.

[toffeeman] 09/6/2023 19:16

All doctors are innovative, just very infrequently.

[1jat] 09/6/2023 17:48

Only some Drs are innovative and most professionals follow the herd, the question is surely whether Renx can generate sufficient supporters that it becomes the normal treatment assessment option….this is likely a long haul (as proven so far) but if a tipping point is reached there will likely be a large upswing in tests…expect many more quarters for this to occur….which is when HPCG will join in…it is a safer investment strategy to buy in when established….

[hpcg] 09/6/2023 15:48

wan I did read that. It was a very light weight prognosis. If revenues were growing strongly that is what they would have written.

[wan] 09/6/2023 08:37

Yes, things have taken much longer than most expected, including expectations of the management, but I sense important change as well as the potential for other catalysts e.g. FDA approval, Local Coverage Determinations and strategic activity.

Perhaps you missed the following -
We are demonstrating payment success across a diverse cohort of insurance entities including individual state Blue Cross Blue Shield and Medicaid plans, Medicare Advantage, and other large for-profit and not-for profit insurance plans. Together with payments from Medicare contractor National Government Services under individual claim review, this growing diversity in payment is providing the basis for our expectation that KidneyIntelX will continue to achieve majority coverage in markets with large populations of diabetes and kidney disease patients during calendar 2023. As a result, we are now able to concentrate resources and focus on building sales, marketing, and customer service functions to support test adoption in regions with comprehensive insurance coverage.

[hpcg] 09/6/2023 08:05

Until actual revenue starts coming in this is an avoid. No Mention of progress in that regard with respect to the current quarter so still nothing to see here.

[wan] 09/6/2023 07:56

Results as expected, with continued and notable progress on building out the sales channels.

I also note that revenues from AstraZeneca has come back onto the radar.

[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 -

[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.


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.


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 -


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 -