Renalytix Share Discussion Threads

[wan] 21/8/2023 07:40

Edit to my post above.

[parvez] 21/8/2023 07:33

Just a formality IMHO.

[wan] 21/8/2023 06:51

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 06:20

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



BW MM

[wan] 03/8/2023 06:47

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 05:06

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 13:20

Thanks wan insightly as ever

[wan] 22/7/2023 07:34

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 06:54

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 09:37

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 07:57

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 07:53

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 07:27

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 07:16

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 07:04

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

[wan] 21/7/2023 06:40

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 18:11

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 16:43

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 14:02

wan - this works:

[mr roper] 20/7/2023 10:23

Sounds positive. Revenue from Florida coming shortly

[wan] 20/7/2023 09:44

I have tried to amend the link with variations and shortened ULR's etc, but to no avail. So for now, just copy and past the title - Why this AI diagnostics company is building a St. Pete lab....... into Google to access the whole story.

[wan] 20/7/2023 09:26

An interesting story -

Published 16 hours ago on July 19, 2023
By Veronica Brezina

Why this AI diagnostics company is building a St. Pete lab

Site selection consultant Mike Gilson, a former exec at global medtech firm Smith+Nephew, worked with McLain on securing a temporary facility on Pasadena Avenue. In the coming months, Renalytix will move into a permanent site near the OneBlood center in South St. Pete.

“OneBlood has all the people and talent to support large-scale blood-processing samples. We want to be close to them and the programs that support this type of business,” McLain said.

The company is working on additional products to measure changes in kidney health over time, identify the most effective therapy for a specific patient and monitor their response to therapy.

McLain explained that Renalytix will build a wet lab space to conduct clinical experiments. The team would also create a research and development hub, training rooms and offices for its back-of-office and corporate operations.

Prior to scouting sites in the Tampa Bay area, the team considered expanding to North Carolina’s Research Triangle, Tennessee or Indiana.

“These cities have regional Medicare administrative contractors who make decisions on health care coverage,” he said.

Medicare administrative contractors are private health care insurers who process claims in assigned territories. Medicare patients make up the majority of Renalytix’s consumer base.

The company has a lineup of existing Florida-based executives, including a lab supervisor, a lab tech and a vice president of sales, market access and a chief medical officer. With the St. Pete location, McLain said there will be additional positions in customer service and billing.

McLain said he has connected with the University of South Florida and the CareerSource organization about building a talent pipeline.

Renalytix has partnerships and contracts with health care systems such as Trinity Health, a not-for-profit Catholic health system operating 92 hospitals in 22 states, and the Orlando VA Medical Center. McLain said he is interested in working with the local VA centers, BayCare Health and AdventHealth.

“We are close to running our 10,000th blood test and are preparing to submit our first Medicare patient samples from Florida in the next few weeks,” McLain said.

Full story - [...]

[wan] 19/7/2023 09:33

I note that EVERSANA recruitment efforts are underway in a number of US territories, the following is for one of those territories (I note that some may have been filled) -

EVERSANA logo
Direct Hire - Account Executive - Kidney Health - Staten Island/Brooklyn/Queens Territory
Brooklyn, NY, United States
Full-time
Compensation Min: $100,000
Compensation Max: $120,000
Department: Sales
Job Family: Sales - Outside

Job Description
Direct Hire - The "Account Executive" is a field-based role with direct customer engagement. This individual will be responsible for the Brooklyn, Queens, and Staten Island territory. Reporting to the Regional Sales Director, the Kidney Health Account Executive will be primarily responsible for engaging and educating healthcare professionals in dialogue about approved indications, clinical evidence, and product accuracy/efficacy to support the appropriate use of KidneyIntelX and future products

Our client, Renalytix, is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosis™ for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D and early CKD (stages 1-3). We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs.

As an Account Executive, you will:
Full description -

[wan] 18/7/2023 08:30

Keeping an eye on the potential from international expansion:

The poor outcomes and costs associated to the current trend toward the late diagnosis of CKD is increasingly being recognised, and thus the calls and recommendations are growing internationally for earlier interventions in detection, identifying and treating risk factors for chronic kidney disease -

Medscape
12 hours ago — Madrid
Experts Call for Early Screening for Chronic Kidney Disease

Scientific societies are therefore advocating for screening at younger ages to reverse this trend and slow the progression of the disease.
Worth reading (registration required)