Renalytix Share Discussion Threads

[wan] 30/6/2023 07:03

Recall that KidneyIntelX addresses type 2 diabetes and chronic kidney disease stages 1-3b.

Even AstraZeneca is highlighting the importance of the benefits of recording a diagnosis at Stage 3 CKD -

Real-world evidence highlights the urgent need to act on the growing global burden of chronic kidney disease
PUBLISHED
16 June 2023

The implications of this evidence data are reinforced by other recently published results from the REVEAL-CKD study, which show the benefits of recording a diagnosis at Stage 3, as it can help to slow kidney health decline with a significant decrease in estimated glomerular filtration rate (eGFR) decline, highlighting the need for earlier screening in at-risk populations.2 Delaying the diagnosis of Stage 3 CKD by one year resulted in an increase in disease progression to Stage 4 or 5 by 40% and the risk of needing a kidney transplant or long-term dialysis treatment by 63%, which are indicators of kidney failure.


PUBLISHED
15 June 2023
Nearly 850 million people worldwide are living with chronic kidney disease (CKD)1, a progressive and potentially fatal condition.2 Yet, the majority remain undiagnosed and untreated.

Early CKD diagnosis may slow progression and avoid cardiovascular complications21
Recent RWE of United States health data has demonstrated the benefits of recording a diagnosis at Stage 3 CKD, showing it can help to improve kidney health with a significant decrease in estimated glomerular filtration rate (eGFR) decline. Delaying the diagnosis of Stage 3 by one year resulted in an increased disease progression to Stage 4 or 5 by 40% and the risk of needing a kidney transplant or long-term dialysis treatment by 63%, which are indicators of kidney failure. This highlights the need for earlier screening in at-risk populations.22

While CKD can be difficult to treat on its own, it can also increase the risk of cardiovascular (CV) diseases and death.23,24 Research continues to show the connection between cardiovascular and renal conditions, and since the heart and kidneys are so closely related, CKD can cause or worsen CV conditions such as heart failure.23,24 Up to one in five patients diagnosed with CKD develop HF, making it the leading CV complication in CKD patients.

[wan] 30/6/2023 06:52

As I have previously covered, in my view, there is very real potential for additional catalysts in the weeks and months ahead as a result of FDA approval.

[mr roper] 30/6/2023 06:15

Fda approval. Well done rnlx

[wan] 30/6/2023 04:07

Renaytix share price was up over 30% in the US after hours on high volume, so a big move expected here too.

[wan] 30/6/2023 03:33

Renalytix updated website -

[wan] 30/6/2023 03:32

FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease

Simple Blood Test Aids Risk Assessment for Approximately 14 Million Eligible Patients in the United States

Diabetic Kidney Disease is the Leading Cause of End Stage Kidney Disease in the United States

LONDON and SALT LAKE CITY, June 29, 2023 (GLOBE NEWSWIRE) — Renalytix plc (LSE: RENX) (NASDAQ:RNLX) announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.

“Meeting the rigorous safety, clinical and analytical validation, and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorization, is a landmark event for health care providers and patients with diabetic kidney disease,” said James McCullough, CEO of Renalytix. “With this approval a new class, Prognostic Test for Assessment of Chronic Kidney Disease Progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products.”

Full release -

[wan] 30/6/2023 03:25

While most of us were in bed..........Big news was released in the US -

Renalytix Gets FDA De Novo Marketing Authorization for KidneyIntelX.dkd
29/06/2023 11:58pm

By Stephen Nakrosis


Renalytix said the Food and Drug Administration has granted De Novo marketing authorization for the KidneyIntelX.dkd prognostic test.

Renalytix said the authorization "affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early stage chronic (diabetic) kidney disease."

De Novo authorization provides a marketing pathway for novel medical devices, the FDA said.

Renalytix also said it believes the authorization will lead to increasing test adoption, expanding insurance coverage, and the pursuit of additional international regulatory approvals.

[wan] 27/6/2023 10:12

My reply on Discord in the US in response to two comments that it is increasingly unlikely that the FDA will provide approval simply because we are approaching the FDA's stated final guidance date -

The indication from the FDA was somewhat more specific this time though: "The FDA has indicated to the Company that in order to provide sufficient time for the completion of the process the Agency is working towards a decision date by the end of Q2 2023. Previous indications from the FDA were for a completion of the process before the end of Q1 2023." So, we are still inline with the guidance provided.

A reminder of the exact wording from the Renalytix release: Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces that the review process with the Food and Drug Administration (FDA) for the KidneyIntelX De Novo marketing authorization application continues at an advanced stage. As part of the De Novo process, and pending a successful outcome of the review, the FDA will prepare a reclassification order and pursue certain internal processes for this class of test prior to communicating the final decision. The FDA has indicated to the Company that in order to provide sufficient time for the completion of the process the Agency is working towards a decision date by the end of Q2 2023. Previous indications from the FDA were for a completion of the process before the end of Q1 2023.

That wording, in my view is not specifically negative, in that the application continued at an advanced stage, and more time was required for the process to complete, hence Renalytix remains optimistic. So, it's worth considering what the 'process' involves in terms of grant or decline, especially if one interprets that a decline would not appear to require additional time, whilst also bearing in mind that there is no legally marketed predicate device, but there could about to be one!

The FDA process - What Are the FDA Final Actions on a De Novo Request?
After review of the De Novo request, the FDA will make a final decision, either to grant or decline. FDA will also consider the De Novo request to be withdrawn in certain situations (see below).

Grant (21 CFR 860.260)
If the data and information provided to the FDA demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and the probable benefits of the device outweigh the probable risks, then the FDA intends to grant the De Novo request and establish a new classification regulation for the new device type.

If the FDA grants a De Novo request:

. The new device is authorized to be marketed and must be in compliance with applicable regulatory controls;
. A new classification regulation for the device type is established;
. The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type, when applicable;
. The FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;
. The FDA posts on its website a copy of the granting order notifying the requester we have granted marketing authorization; and
. The FDA generates and publicly discloses a decision summary.

The FDA has published decision summary documents for devices classified through the De Novo process, beginning in 2010. The De Novo decision summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the FDA's decision to grant a De Novo request. The De Novo decision summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate.

Decline (21 CFR 860.260)
Generally, the FDA will decline a De Novo request if:

. General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or
. The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or
. The probable benefits of the device do not outweigh the probable risks.

If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The FDA will issue a written order to the requester identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester generally should either submit an application for premarket approval under section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information.

The above and much more is included in De Novo Classification Request -

[wan] 26/6/2023 08:30

Toffeeman...I am sure there will be a few others too.

I like the fact that KidneyIntelX is a platform technology, where we can expect the inclusion of additional biomarkers (increased moat) and disease versions (the same for Verici).

[toffeeman] 26/6/2023 08:02

not Genincode Wan?

[wan] 26/6/2023 06:41

Just as an aside, some investors may have missed out from the first-order effects from AI (eg Nvidia etc). However, if we can work out where the cascading impact from the implementation of AI & ML will have significant and meaningful multi-year impact, then smaller investors could be well rewarded. In short, Renalytix, the first company to develop and commercialize an artificial intelligence (AI) powered in-vitro diagnostic for kidney disease, could be one such place, given the market size and need, for investors to benefit from 2nd-order and 3rd-order effects from AI & ML.

From an AI in healthcare perspective, I would also include Verici Dx (VRCI).

[wan] 24/6/2023 09:33

Apologies in advance for a long post.

Another reason that recently buoyed my rationale for other potential catalysts in the wings (aside from the CEO's previous comments), is that Renalytix' work with AstraZeneca has continued. Plus, recall that Renalytix separately announced in 2020 that it entered into a data sharing agreement with a top ten global pharmaceutical company, without divulging the name -

Data sharing agreement with a leading top ten global pharmaceutical company

RenalytixAI also announces that it has entered into a data sharing agreement with a top ten global pharmaceutical company providing RenalytixAI with access to a deep data repository from completed clinical studies in DKD. RenalytixAI plans to analyze this data in combination with corresponding biomarker data to evaluate KidneyIntelX performance in predicting patients’ responses to novel therapeutic agents indicated to slow or prevent kidney function decline. Data analysis will also include evaluation of KidneyIntelX over multiple time points within a six year follow-up period, potentially demonstrating the value of dynamic, repeated KidneyIntelX measurements.

For further context, the purpose of the collaboration with AstraZeneca was the following: The first stage will assess the impact of AI-enabled in vitro diagnostic solutions to optimize utilization of therapeutics in CKD under current standard of care protocols. Based on study outcomes, a multi-center, randomized controlled trial will be initiated to evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia. The studies will be conducted in coordination with the Mount Sinai Health System, where KidneyIntelX testing and care management software are currently being deployed for commercial clinical use.

RenalytixAI and AstraZeneca will use KidneyIntelX with the aim to:

· Help improve physician uptake and patient adherence to existing potassium-binding therapeutics and other approved products in CKD through early identification of previously hidden high-risk patient groups

· Accelerate patient identification and recruitment for clinical trials

· Complement commercialization efforts with outcomes from KidneyIntelX results

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, and clinical trial selection etc, would be best served by, or require FDA approval.

And what also caught my attention recently, and appears to tie in with the work undertaken by Renalytix and AstraZeneca detailed further above, which also included initiation and validation via clinical trial, and also aligns with the recent inclusion of UACR testing by Renalytix, was the following -

PUBLISHED
16 June 2023
The existing unmet need despite today’s standard of care

Current treatments for CKD include those that interact in the renin-angiotensin-aldosterone system (RAAS) to help regulate blood volume, electrolyte balance and systemic vascular resistance. Clinical studies have shown that with these treatments there is an initial reduction in proteinuria which positively correlates with the reduction in risk for renal disease progression. However these treatments can be underused because they risk increasing potassium in the blood, known as hyperkalaemia.4 In addition, research presented at European Renal Association (ERA) Annual Congress shows that people with more advanced kidney disease, as indicated by their proteinuria levels, are more susceptible to hyperkalaemia.5 As kidney function declines, the kidneys are less able to remove potassium from blood.6 Hyperkalaemia is a common complication in CKD, affecting up to 40-50% of patients.7 It is associated with an increased risk of cardiovascular events and death.8-10

These challenges may limit current treatment options for patients with poor kidney function and significant proteinuria. There is a need reduce for future treatments to reduce proteinuria whilst managing the risks of hyperkalaemia to slow disease progression.

Delivering a step change in identifying patients with proteinuria

Currently, despite compelling data, only a minority of patients are screened for high proteinuria. Proteinuria is assessed by measuring the albumin creatinine ratio (ACR) in a patient’s urine and, results may vary even within the same individual, making it harder to identify meaningful biologic changes and increasing complexity of clinical trials.

In research presented at ERA Annual Congress 2023 we presented a new diagnostic approach to identify patients with proteinuria using machine learning to predict ACR levels from Electronic Health Records. The model may in the future support identifying undiagnosed proteinuria and be applied in pre-screening for clinical trials. We intend to validate the model further in an upcoming CKD trial. Further development of the technique may lead to a future where we can predict progression of kidney disease without needing to take a urine test at all.



Whether this relates in any way to Renalytix remains to be seen, but AstraZeneca is not the only pharma in play that could utilize KidneyIntelX in addressing CKD (cue the unnamed top ten pharma), which (unfortunately) is a huge and growing global market, where FDA 'differentiation' could make a material difference -

June 23, 2023 08:25 AM Eastern Daylight Time

INGELHEIM, Germany & INDIANAPOLIS, Ind.--(BUSINESS WIRE)--The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.1 Empagliflozin is currently indicated for the treatment of heart failure and type 2 diabetes in adults.5 When approved, empagliflozin’s indications in the EU will include adults living with CKD, paving the way for an approach to managing the amplified risks of interconnected cardio-renal-metabolic conditions.



June 22, 2023 07:30 AM Eastern Daylight Time

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today the initiation of FINE-ONE, a global, multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase III study to evaluate the efficacy and safety of a new investigational use of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). The primary objective of the study is to demonstrate efficacy of finerenone over placebo in reducing urine albumin to creatinine ratio (UACR) over 6 months.



So, there is potential now for guiding the utilisation of therapeutics, and also further potential from lots of studies/trials where KidneyIntelX could be effectively deployed, and utilised beyond.

[wan] 23/6/2023 06:59

Although not immediate (plus you need FDA approval first), TCET will now happen quite soon, as it is now clear it will, and it needs to!

And it further underscores the catalytic event that FDA approval should represent, although I firmly believe there are more individual potential catalysts than the TCET pathway alone.

[wan] 23/6/2023 06:38

Highlighted by Ramyris on Discord in the US -

Notice with Comment - Transitional Coverage for Emerging Technologies (CMS-3421-NC)
Jun 22, 2023

The Centers for Medicare & Medicaid Services (CMS) issued a proposed procedural notice outlining a new Medicare coverage pathway to achieve more timely and predictable access to new medical technologies for people with Medicare. The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.

The TCET pathway uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain Breakthrough Devices.
Full release -

In short: it's the creation of an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics. Transitional coverage for these technologies would bolster the innovation ecosystem and provide Medicare patients’ swift access to new technologies that existing therapies may be unable to address.

Under TCET, Medicare coverage of an innovative, FDA-approved device under TCET would be expeditious, and would allow for ongoing collection of real-world data and evidence to understand better the true impact of lifechanging medical technologies on Medicare patients.


On the last point, readers will already appreciate the level and degree of multi-year real-world evidence that Renalytix has assembled and is on-going.

An example of which is currently being presented at the American Diabetes Association 83(rd) Scientific Sessions meeting include late-breaking data from a multi-year real-world evidence study, extended validation of KidneyIntelX, and a cost-effectiveness analysis addressing economic benefit in the VA population. In addition to multiple data presentations, Renalytix will be hosting three medical education events covering real-world evidence data unveiled at the conference so that clinicians may discuss and engage with the Renalytix leadership team as well as their peers in nephrology, endocrinology, and primary care providers.

American Diabetes Association 83(rd) Scientific Sessions presentations will be displayed over three days June 24-26, 2023, and moderated at the specified times below. Presentations related to KidneyIntelX will also be published on the journal Diabetes(R) website.

[wan] 21/6/2023 10:13

A few items that recently caught my attention:

I note that Renalytix have recently undertaken a number of updates to their website -

KidneyIntelX. Designed to be scalable. Additional discoveries and developments in novel biomarkers, expanded clinical indications and integrated digital technologies.

New indications are on the horizon with our KidneyIntelX platform:


There now appears to be two versions of the test available, KidneyIntelX and intelX.dkd - (scroll down to 'available today')

I had not seen the following Renalyix website until recently, which appears to be directed at clinicians (again two tests, plus UACR are listed) -

We help clinicians advance kidney health.
Renalytix Labs -

UACR testing is not a particularly new aspect per se, and KidneyIntelX generates clinical recommendations for testing UACR e.g. twice a year, alongside pharmacologic strategies etc, but it's clear that Renalytix is offering the test with a one day turnaround -

Renalytix is committed to helping clinicians advance kidney health. To that end, we now offer UACR testing to help doctors diagnose, stage, monitor and define a treatment plan for kidney disease. It is the perfect complement to KidneyIntelX™ prognostic testing.

[wan] 17/6/2023 07:08

In my view, FDA approval will represent confirmation of a paradigm shift, and the diagnostic industry will definitely take note.

It's perhaps easily overlooked that Renalytix FDA submission is unique, hence the FDA has designated KidneIntelX as a Breakthrough Device and providing Renalytix with the opportunity to work hand-in-hand with the FDA because it will be predicative. In other words, a point of comparison for new medical devices seeking similar approval.

OK it has taken longer than 'everyone' expected, but it was always going to technically challenging, demanding, and time consuming, as it will form the bedrock of how AI & ML is integrated into future medical devices.

With the above in mind, I note recently that the FDA issued new draft guidance with regard to 'new' submissions, which effectively demonstrates the advanced stage the FDA are at -

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions


One might even ask whether that draft guidance was as a result of interactions with Renalytix.

The following two articles provide excellent, thought-provoking coverage of the above -

16th June 2023
FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing.

In a statement by FDA following the latest drug manufacturing discussion paper, the agency notes that, “Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; they are now part of how we live and work. . . Ultimately, AI/ML can help bring safe, effective, and high-quality treatments to patients faster.” However, while FDA understands the benefits that AI can offer, it also understands that many challenges accompany AI.

We will offer a high-level overview of the items discussed in these pieces, as well as some insights for industry.

Overview of FDA’s Draft Guidance for Medical Devices
In this draft guidance, FDA highlights a major concern for AI/ML-enabled medical devices, predetermined change control plans (“PCCP”). FDA hopes the guidance will promote safe and effective devices that use ML models trained by ML algorithms. One primary benefit of an AI/ML-enabled medical device is the product’s ability to improve ML model performance through iterative modifications. To support this development, FDA provides recommendations on the marketing submission content for a PCCP. This applies to marketing submissions through the 510(k) pathway, the PMA pathway, or the De Novo pathway, but the guidance may also apply to components of a combination product.

Full article -

The Legal and Regulatory Landscape Evolving with AI in Life Sciences
June 15 2023
The FDA appears flexible and careful in developing an AI/ML regulation framework, offsetting the need to facilitate innovation while protecting public health. For example, Bondoc pointed to the agency's drafted guidance on Predetermined Change Control Plans (PCCP) for AI/ML-enabled device software functions, attempting to address a significant issue facing emerging technology.

Historically, changes to a cleared or approved medical device that could significantly affect the safety or effectiveness of the device required submitting a premarket notification 510(k). Yet, the notification program is "fundamentally at odds with the use of AI/ML in medical devices that facilitate continual improvements and modifications to the device based on data gathered while in use," said Bondoc. The FDA aims to develop a regulatory approach tailored to AI/ML-enabled devices, allowing for safe and rapid modifications in response to new data while ensuring safety and effectiveness.

Full article -

[wan] 16/6/2023 07:48

Clearly a new wave of AI in healthcare is upon us, which has broad implications, so it's surprising in my view that that fact currently appears to not be adequately reflected in Renalytix share price, hence my comment above that FDA approval could provide an additional catalyst in terms of a better appreciation of the AI factor.

Not to mention the significant amount of know-how which has been accumulated with regard to the long and complex FDA process and introducing a new technology into primary care, which will serve well the fact that in the medium term (cue partners perhaps) Renalytix AI 'scalable platform' will be deployed by Renalytix (and co?) into other countries beyond the US, and importantly into addressing other indications and managing other chronic conditions.

In my view, to some degree the same applies to Verici Dx (VRCI) in terms of the underappreciated AI factor (partnered with US giant Illumina) and the platform factor. Renalytix currently holds 9.8m shares in Verici, where news is also imminent.

[wan] 15/6/2023 07:53

If FDA approval is obtained (which would be great if it coincided with the Presentations announced today), and given that such an approval and the resulting media coverage would highlight the technology utilised to a wider audience, it will be interesting to see if Renalytix is lifted not only by the approval itself, but also lifted by the current interest and optimism surrounding AI and ML.

[wan] 15/6/2023 06:58

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

[wan] 12/6/2023 12:14

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 07:24

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 07:22

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 18:16

All doctors are innovative, just very infrequently.