FAQ on CKD Screening and Point-of-Care Testing (MATLOC)

Summary: Despite clear guidelines, fewer than 50% of at-risk individuals in Canada and the US are screened for CKD. A four-step process with small drop-offs at each stage leads to a cumulative attrition of over 50% and persistent screening gaps.

Details:

Despite strong guideline recommendations (KDIGO¹), nearly 98 million people in Canada and the US are at risk for CKD—but fewer than 50% are screened, even in top clinics 3-5 . Strong guideline recommendations for CKD screening also come from the following organizations: The National Kidney Foundation, American Diabetes Association, and American Heart Association 6-8 .

Screening is clinically simple:

1. Urine test for albumin-to-creatinine ratio (ACR)

2. Blood test for estimated glomerular filtration rate (eGFR), ideally with creatinine and Cystatin C 1,2

So why the gap?

The gap exists because the current 4-step process breaks down:

1) Provider identifies an at-risk patient →

2) Orders both urine and blood tests →

3) Patient completes the tests →

4) Provider follows up and prescribes treatment.

Each step loses people. Even with 85% success at every stage, the cumulative completion rate is just 52% (0.85**4). Knowledge translation efforts haven’t fixed this 4,5 .

References:

1. Stevens et al., Kidney Int, 2024 – KDIGO 2024 CKD Guidelines

2. Inker et al., NEJM, 2021 – Cystatin C & race-free eGFR equations

3. Screening and Diagnosis of Chronic Kidney Disease in Adults Living With Diabetes: A Retrospective Cohort Study Using the Canadian Primary Care Sentinel Surveillance Network - Canadian Journal of Diabetes

4. Bello et al., JAMA Netw Open, 2019 – CKD care quality in Canadian primary care

5. Yuen et al., Am J Kidney Dis, 2023 – CKD progression & care gaps in primary care

6. National Kidney Foundation, 2024 – Importance of measuring eGFR and urine ACR for high-quality CKD care

7. ADA, Diabetes Care, 2024 – Guidelines on CKD detection and management in people with diabetes (Standards of Care, Section 11)

8. AHA, Circulation, 2023 – Clinical guidance on CKD risk, detection, and cardiovascular implications from the American Heart Association

Summary: Yes. POC testing enables diagnosis and treatment within a single patient-provider encounter, reducing dropout rates. This approach is endorsed by the WHO and proven effective in other conditions such as HIV and malaria. In CKD, POC screening in remote Canadian communities improved detection and facilitated timely treatment .

Details: Use of point of care tools is well established in many areas of medicine including malaria testing and treatment, and in the diagnosis and treatment of sexually transmitted diseases such as HIV 1–3 .

POC testing allows for the ability to:

1. Rapidly diagnose and prescribe treatment in a single patient-provider interaction (a single appointment).

2. Eliminate multiple steps in the testing process, and significantly increase the rate of diagnosis and initiation of therapy 1-3 .

For these reasons, POC based strategies are strongly endorsed by the World Health Organization 1-3 . In the CKD space specifically, our group published our extensive experience screening for CKD in remote communities in Manitoba, Canada. We demonstrated that screening with POC systems improved identification of CKD 4-6 .

References:

1. WHO, HIV Dual Testing Guidelines (2019)

2. WHO, Rapid Diagnostic Tests for Malaria (2024)

3. WHO, Tuberculosis Diagnostic Testing Report (2023)

4. Komenda et al., AJKD, 2016 – FINISHED program

5. Harasemiw et al., CMAJ, 2021 – POC CKD screening in rural Manitoba

6. Frejuk et al., CMAJ, 2021 – Screen, triage, and treat for chronic disease in Indigenous children

Summary: Absolutely. Health economic models show that CKD “screen-and-treat” strategies are cost-saving under most scenarios, even with upfront expenses. This is validated by both our own published modeling and external studies.

Details: Our team has published economic models showing that a screen and treat strategy was cost saving (i.e. economically dominant) under most model assumptions, despite high up-front costs. These findings are consistent with the most recent publications addressing cost-effectiveness of CKD screening. Our work led to the establishment of the national Kidney Check program, , which offers in-community point of care screening for CKD in remote communities in Canada.

References:

1. Ferguson et al., Kidney Int, 2017 – CKD screening is cost-effective in Canadian Indigenous communities

2. Cusick et al., Ann Intern Med, 2023 – US-wide CKD screening cost-effectiveness analysis

3. Curtis et al., Kidney Check – Patient-centered POC screening in rural and remote Canada

4. Curtis et al., Kidney Int Rep, 2021 – Quality assurance platform for Canada’s national Kidney Check program

Summary: MATLOC is designed to price at ~$20 USD/test (the consumable). This is well below the $36 Medicare reimbursement, which allows providers to profit from each test. Additionally, MATLOC’s simplicity, portability, and quick results integrate easily into clinical workflows without disrupting patient flow.

Details: We have actively engaged with leadership in major primary care and nephrology networks in both US (Kaiser, Geisinger, Optum) and Canada (Provincial Health Agencies) to better understand the path to adoption of MATLOC following regulatory approval. We believe we can present these Networks with a solid value proposition as follows:

1. Per test profit for clinics: MATLOC is designed to cost < $20 USD/test, well below the $36 Medicare reimbursement - allowing providers to profit from each test. In this price sensitive market, the current high per test cost of our competitors (~$45USD) is a barrier to adoption for other currently available POC devices;

2. Commitment to helping clinics optimize implementation of POC testing with MATLOC, minimizing patient flow disturbance. We are working on process mapping of clinic flow to generate strategies and SOP’s for optimal patient flow.

3. Expectation of improved screening and treatment rates with a POC testing approach, allowing practices to achieve Value Based Care targets and capture associated reimbursements. This will be a significant source of additional revenue for clinics participating in the Centers for Medicare & Medicaid Services Quality Payment Program.

4. Predicted lower downstream health costs from lower rates of unscreened/untreated CKD 2-3 .

5. Mobilizing interest by professional societies, patient societies, and end-users will be another critical element for adoption. The team will be seeking endorsement from key US and Canadian based organizations such as the National Kidney Foundation, American Society of Nephrology, Canadian Society of Nephrology, and Kidney Foundation of Canada.

References:

1. CMS, Quality Payment Program Overview, 2024 – Medicare & value-based care incentive model for clinicians participating via MIPS or Advanced APMs

2. Ferguson et al., Kidney Int, 2017 – CKD screening is cost-effective in Canadian Indigenous communities

3. Cusick et al., Ann Intern Med, 2023 – US-wide CKD screening cost-effectiveness analysis

Summary: Yes. Clinics are unlikely to adopt diagnostics that operate at a financial loss. MATLOC overcomes this barrier by ensuring per-test costs remain below reimbursement thresholds, directly incentivizing adoption. Similar reimbursement-aligned models have driven success in other health domains.

Details: As a specific example to the above, the UK’s QOF initiative all showed that financial rewards increase adherence to guideline-based care. Conversely, very recent data from the UK shows that discontinuation of financial incentives (i.e. payment) for albuminuria testing in patients with diabetes reduces the rate of testing, validating the important role that financial incentives play in achieving healthcare targets 1 . In CKD, incentivizing test adoption through reimbursement parity or bonuses could bridge screening gaps.

References:

1) Stewart et al., BMC Medicine, 2024 – UK primary care insights on barriers and incentives in CKD testing and management.

Summary: Simply put, current POC platforms are just too large, expensive (>$45/test), and complex. Cost per test exceeds Medicare reimbursement and makes adoption financially impossible for clinics. MATLOC addresses these limitations by offering an accurate, integrated, low-cost, and hand-held alternative.

Details: Several commercial point of care devices are available to measure diverse urine and serum analytes. They range widely in size and weight with platforms like:

• Abbot iStat at the smaller end (size / weight of a 1970’s military field telephone) and

• Siemens DCS Vantage at the higher end (size/weight of a tabletop office FAX/copier/printer).

Specific single use cartridges are consumed for specific panels of tests, typically costing $10-20 CAD per cartridge/test depending on the analytes. Our team has direct experience with both iStat and DCA Vantage. The accuracy of the iStat was significantly lower (compared to a reference lab) than that of the DCA Vantage in our internal validation testing, leading us to choose the heavier, more expensive but more accurate DCA Vantage in our Northern CKD screening initiatives in Canada 1-4 A complete kidney panel (urine ACR and dual marker eGFR) requires 3-4 cartridges at a total cost of $40-60 per panel, exceeding reimbursement from medicare and making adoption financially impossible for clinics. In contrast, MATLOC will be priced at $20 per complete kidney panel, much less than the reimbursement, thus incentivizing testing.

References:

1. Komenda et al., AJKD, 2016 – FINISHED program

2. Curtis et al., Kidney Check – Patient-centered POC screening in rural and remote Canada

3. Curtis et al., Kidney Int Rep, 2021 – Quality assurance platform for Canada’s national Kidney Check program

4. Lavallee et al., Can J Kidney Health Dis, 2015 – Mass CKD screening methodology and demographics in rural First Nations communities in Canada

Competitive Advantages of MATLOC

Compared to the competition, the MATLOC system aims to have the following advantages:

1. First in the market: As a fully integrated device measuring ACR and dual-marker estimated GFR from a single chip/test. In contrast, our competitors require three to four separate chips/tests to obtain the same data, which adds to their cost of use.

2. Low cost per test to incentivize use: Materials for each consumable paper-based CKD chip costs less than 50 cents. We estimate manufactured chips will cost about $5 each (assuming manufactured cost = 10X materials cost). This means each CKD panel (Urine ACR plus Serum Cystatin-C and creatinine based eGFR) could retail for ~$10-20, well below the $36 reimbursement paid by Medicare. Users therefore generate profit with every test done with MATLOC. In contrast, the cost for this panel with existing point of care devices (e.g. Siemens, Abbott) at ~$45 is much higher than the reimbursement users can claim from Medicare, representing a substantial net loss per test. This constitutes an absolute economic barrier to adoption of currently available POC devices for CKD screening, explaining the lack of market adoption of POC CKD testing at present.

3. Low cost of optical analyzer. We are projecting a materials cost of $50 for the optical analyzer and a probable sale cost of $500 per unit, which can be discounted further to incentivize use. In comparison, typical point of care analyzers cost $3,000-$4,000USD retail.

4. Excellent portability/hand-hold ability while maintaining accuracy. Most commercial POC analyzers are table-top/bench-top systems (e.g. DCA Vantage). Smaller systems exist but are less accurate. MATLOC will be smaller than the iSTAT but have quantitative accuracy similar to the larger POC systems.

5. Point of care permits single step screen and treat. Small sample volumes are required; results will be available within 20 min (vs. 24-48h turn around for standard clinical lab testing), permitting screening and treatment in a single patient provider interaction.

Summary: While implementing new technology can present challenges, MATLOC will be designed to minimize operational barriers. The product’s ease of use and integration into clinic workflows can help reduce common obstacles such as staff training time and workflow disruption.

Details:

• Minimal staff training required: MATLOC’s simple, intuitive design ensures that staff can quickly adopt it without extensive training.

• Seamless integration with existing workflows: MATLOC will be compatible with Electronic Medical Records (EMRs) and billing systems, ensuring minimal disruption to clinic processes.

• Point-of-care convenience: With rapid, on-site results, MATLOC can eliminate the need for follow-up appointments, saving time and streamlining care.

• Cost-effective implementation: MATLOC’s low-cost per test and lack of additional infrastructure requirements make it affordable and easy to deploy in various healthcare settings.