Renalytix Share Discussion Threads

[mikemine1] 23/8/2023 18:16

Well done wan. I don't know how you find all this nor how you find what links it all together. I couldn't do it.

As mentioned, payment have been going on for a while. I wonder how the revenue stream is growing.

[wan] 23/8/2023 14:18

Edited message to 'tomorrow', got ahead of myself!

[wan] 23/8/2023 09:34

Recall that previously the National Government Services (NGS) initiated payment of claims for KidneyIntelX testing for patients with Medicare coverage that have met appropriate medical necessity criteria.

Effective July 1, 2022, claims for KidneyIntelX tests have been processed and paid by NGS using the ICR process. Under this payment methodology, NGS reviews each claim to determine its medical necessity based on the clinical evidence supporting its intended use. Payment timelines are within Medicare's 30-day targeted timeframe for payment.


And note that at that time KidneyIntelX did not have FDA approval, which it of course now has.

A reminder that tommorow there is the following NGS Contract Advisory Committee (CAC) meeting regarding KidneyIntelX Test scheduled for August 24, 2023. The CAC advises and consults to review Local Coverage Determinations -


On top of the fact that KidneyIntelX now has FDA approval, and that substantial supportive clinical study data has since been reported, including recently -

Four new data presentations, including late breaking clinical study data, underscores the value of KidneyIntelX testing in helping slow progression of chronic kidney disease in type 2 diabetes patients


Not to mention Renalytix launch of its Clinical Advisory Board, a world-leading, multi-disciplinary clinical group, to help advance the use of FDA authorized kidneyintelX.dkd™ in mitigating uncontrolled kidney disease progression


The fact that these CAC meetings usually include presentations of comparative utilisation data, along with other evidence used in developing an LCD (one assumes that could include substantive supporting clinical study data), hopefully then the outcome will be a positive one.

[wan] 21/8/2023 12:44

An interesting recent podcast with James McCullough, a couple of excerpts follow -

Welcome to the Empowered Patient Podcast with Karen Jagoda. This show is a window into the latest innovations in digital health and the changing dynamic between doctors and patients.

James McCullough: KidneyIntelX is the in vitro prognostic, which we just got FDA approval on and is now reimbursed by several major insurance companies. Medicare also pays for it. We have a unique opportunity to go in and start to practice a much higher level of preventative medicine by understanding who is at high risk early.

James McCullough: For KidneyIntelX version one, which was just authorized out of the Food and Drug Administration on a de novo marketing authorization through
Breakthrough Device designation, we are looking at adults with type 2 diabetes
and early-stage kidney disease, which is defined as early as stage 1. These are
early-stage patients with diagnosed kidney disease. They have diabetes, and
now the real issue is where they stand in the risk spectrum of progressing. We
are actively working on new test versions where we can add additional protein
biomarkers, genetics, and electronic medical record features.

One of the big advantages of KidneyIntelX is that it runs off of a non-linear
artificial intelligence-enabled algorithm that can ingest more and more
information—there is really no limit. We can then turn around and validate that
algorithmic result against a specific outcome, so we can start to expand the
indicated uses of KidneyIntelX.

James McCullough: The critical near-term milestone for us is driving adoption. We are engaged in education programs. We have a number of strategic partnership discussions going on right now for players who are interested and can contribute to
entering into the diabetes management space and a chronic disease management space. Our real short-term objective is now that we have an FDA authorized test with great outcomes data, reimbursable by insurance, is to build our commercial sales and marketing reach.

The goal is now to make KidneyIntelX testing as ubiquitous as possible to diabetic kidney disease patients in the United States through multiple channels, including hospital system partnerships, insurance companies, and other strategic partnerships. Insurance companies, particularly Medicare and Medicaid, are struggling to control the cost around diabetic kidney disease. We're deploying a direct sales force now with customer service and medical science liaison support to support messaging directly to primary care physicians

Full transcript -

[mrmarmalade] 21/8/2023 09:00

Agreed...along with the recent Middle East Agreement...all good.

[wan] 21/8/2023 08:40

Edit to my post above.

[parvez] 21/8/2023 08:33

Just a formality IMHO.

[wan] 21/8/2023 07:51

And if the inclusion comes to pass (likely in my view), and aside from being significant for broader adoption in the US, that could also add materially to the dynamics in terms of international expansion.

[mrmarmalade] 21/8/2023 07:20

Nice to see this kept in the final report...



BW MM

[wan] 03/8/2023 07:47

Presumably the above is a direct result from FDA approval.

I note todays news of the formation and launch of a Clinical Advisory Board containing a wide range of highly respected individuals, to help advance the use of FDA authorised kidneyintelX.dkd. And conservatively providing food for thought in terms of the use of KidneyIntelX in only a relatively small percentage of the 'initial' target audience in the US would result in $1bn in revenues. International expansion adds to the dynamics.

[wan] 03/8/2023 06:06

NGS - National Government Services is the MAC for Jurisdiction 6 – Illinois, Minnesota and Wisconsin, and Jurisdiction K – Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut and New York.

I note the following NGS Contract Advisory Committee meeting regarding KidneyIntelX Test scheduled for August 24, 2023 -

[9degrees] 22/7/2023 14:20

Thanks wan insightly as ever

[wan] 22/7/2023 08:34

To add to that and provide further context, I have seen many examples within Medical Coverage Policies of available tests that are not FDA approved being described as "the following are considered experimental, investigational or unproven", and "Contracts exclude from coverage, among other things, services or procedures that are considered investigational". This type of wording ultimately restricts the adoption and use of tests that come under that criteria.

FDA approval changes that, and to quote Tom McLain, FDA approval "overcomes payer responses of too early, experimental, investigational; it helps accelerate guideline inclusion".

[wan] 22/7/2023 07:54

I recently posted that FDA approval is widely recognised beyond the US, so it's good to read a LinkedIn post from Renalytix President, Tom McLain, highlighting that fact, and explaining the significance that FDA approval has on both the US market and 'international' markets -

International Distribution – Why Now?

FDA approval is significant for a diagnostic test like KidneyIntelX.dkd in the U.S. market. Approval drives broad clinical acceptance; it overcomes payer responses of too early, experimental, investigational; it helps accelerate guideline inclusion.

But the health care challenge our test addresses is not limited to the United States. Worldwide there are 422 million people with diabetes and more than 800 million people with chronic kidney disease. FDA approval also creates near-term commercial opportunities outside the U.S. There are many markets that will grant regulatory licenses in country based on FDA approval.

This has been an effective pathway to early non-US adoption for many FDA approved tests in oncology. Regional laboratory distributors call on oncology and specialty practices. That offers U.S. based lab service providers a local partner for licensing, sales, marketing and payment.

Building on that model Renalytix plans to establish appropriate distributor relationships in selected markets where there is a significant clinical need for KidneyIntelX.dkd testing and a clear pathway to payment. Full post -

[mikemine1] 21/7/2023 10:37

Population of the area covered is over 50 million so potential diabetic market is 10 million given that the rate of diabetes in the population is stated at a whopping 20%.

[1jat] 21/7/2023 08:57

Being parochial, I suspect the UK approach will be based on NICE assessing whether testing is value for money, ie it must pay for itself….if it does that it is exactly the type of innovative treatment monitoring/planning that the NHS needs…..if it can get over using public money to procure independent test results.

[wan] 21/7/2023 08:53

Edit to post 2287 - Given that the US and the Middle East are not the only countries with high rates of T2D and CKD, where KidneyIntelX could make a material difference, accordingly I look forward to additional updates regarding international expansion.

[mr roper] 21/7/2023 08:27

Well they certainly seem to be making good progress. Hopefully we'll get news on national medicare determination later this year as well. A few more of these type of deals and making a dent in Mt sinai and wake forest TAM could see a bumper q4 onwards

[donald pond] 21/7/2023 08:16

It is very positive. The big question is how quickly a distribution agreement can turn into meaningful revenues but you might hope it could be quicker than in the US.

[hsdeo] 21/7/2023 08:04

Great new, expansion continues, need to get these distribution deals working into hard sales. could be a transformative year!

[wan] 21/7/2023 07:40

Good to see from todays news that international expansion is indeed a strategy and a reality.

Given that the US and the Middle East are not the only countries with high rates of T2D and CKD, where KidneyIntelX could make a material difference, accordingly I look forward to additional updates regarding international expansion.

For the sobering numbers -
The IDF Diabetes Atlas 10th edition reports a continued global increase in diabetes prevalence, confirming diabetes as a significant global challenge to the health and well-being of individuals, families and societies.

[supernumerary] 20/7/2023 19:11

No probs - I'm still not quite sure about the rules on posting links. I suppose I could set up a dummy account and experiment, but I don't have the phone app, and anyway, life's too short :¬)

BTW thanks for the link, and all the other research - a welcome change from much of the dross that appears on these boards.

[wan] 20/7/2023 17:43

Thanks Supernumerary for providing the link (it might be because I am not a premium user as I tried providing that link).

[supernumerary] 20/7/2023 15:02

wan - this works:

[mr roper] 20/7/2023 11:23

Sounds positive. Revenue from Florida coming shortly