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{

1 in 4 Adults
}
ONLY ONE in FOUR U.S. Adults
currently living with kidney disease today
are actually aware7

{

1 in 4 Adults
}
ONLY ONE in FOUR U.S. Adults currently living with kidney disease today are
actually aware7

The Burden of Kidney Disease

Kidney disease is recognized as a public health threat and a global epidemic that affects approximately 850 million people worldwide1, and nearly 40 million, or one in every seven, U.S. adults.2,3

Chronic kidney disease (CKD) is considered a “silent killer”1 – the onset is generally insidious, and although the ongoing renal damage is destructive and irreversible, it will often progress to end-stage renal disease (ESRD) with very little to no symptoms.3-5

The diagnostic rate of CKD in the U.S. is estimated to be a dismal 26.5%7, or in other words, only one in every four adults currently living with kidney disease today are actually diagnosed by their doctor!

Symptoms

Even in the very late stages symptoms are typically mild and nonspecific – they may include increased or decreased urination, increased thirst, some cases may cause lower extremity swelling, and severe states occasionally result in nausea and vomiting.3,4

Awareness
of initial stage.

<0%
CKD - Stage 1

Awareness
of the FINAL stage.

<0%
CKD - Stage 4

{

$ 0 +
Yearly Tax Payer Burden
Healthcare spending by Medicare alone for both CKD and ESRD was $75 billion and $35 billion in 2015, respectively6 – this monumental financial burden totals to >$100 billion in total direct costs in the U.S. every year – CKD alone accounts for ~20% of all annual Medicare spending.6-8
}

{

$ 0 +
Yearly Tax Payer Burden
}

Healthcare spending by Medicare alone for both CKD and ESRD was $75 billion and $35 billion in 2015, respectively6 – this monumental financial burden totals to >$100 billion in total direct costs in the U.S. every year – CKD alone accounts for ~20% of all annual Medicare spending.6-8

Complications of CKD

Although patients with CKD often do not feel ill they are at a particularly high-risk for developing severe complications,1
such as

  • Cardiovascular disease (CVD): 2-3x increased risk6,9-10
    • i.e. Coronary artery disease, heart failure, or suffering from a heart attack and/or stroke
  • Death due to CVD: 20-30x increased risk9-10
    • People with CKD are much more likely to die due to CVD than any other cause, including renal failure
  • Annual mortality rate: 10-15x higher rate9
  • Shortened life expectancy
    • Those with diabetes and CKD have an average shortened lifespan of ~16 years11
  • Hospitalization rate: 50-150x increased risk (dependent on CKD stage)
  • Vital life-long dependency on dialysis, or renal transplant due to ESRD
  • Developing and suffering from complications of:
    • Anemia: 2-4X increased risk12
    • Hyperparathyroidism: 5-10x increased risk12
    • Acidosis: 2-3x higher risk12
    • Hyperphosphatemia (high levels of phosphate in blood): ~2x the risk12
    • Hyperparathyroidism: 5-10x increased risk12
    • Acidosis: 2-3x higher risk12
    • Hyperphosphatemia (high levels of phosphate in blood): ~2x the risk12
Asset 1

Challenges In CKD

Diagnosing CKD is difficult for physicians, as it is estimated that only 26.5% of adults with CKD in the US are actually diagnosed7 Patient’s often do not know they are sick due to the asymptomatic nature of CKD – there is no common complaint to help physicians know what to look for. Although people with early CKD usually do not feel ill until kidney function is severely compromised, they are still at an increased risk for CVD, lifetime dependency on dialysis, and early death. The criteria needed for a CKD diagnosis is mostly based on a test that is timely and complicated. Estimated glomerular filtration rate (eGFR) is an equation-based calculation that tells doctors how well your kidneys are filtering harmful toxins and waste from the body – patient variables used to make the calculation are listed below:
    • Age
    • Gender
    • Race
    • Serum Creatinine
Who needs to be screened for CKD?

Those who are at high risk for developing Chronic Kidney Disease, including those diagnosed with:

    • Hypertension
    • Type 1 or Type 2 Diabetes
    • Stage 1 or Stage 2 Chronic Kidney Disease
    • Prediabetes
    • Cardiovascular disease (CVD)
    • Congestive Heart Failure (CHF)
    • One who has a first-degree relative (i.e. father, mother, brother, sister) diagnosed with Chronic Kidney Disease
    • Elderly (>65 years old)
    • Obesity (Body Mass Index, BMI >30.0)

The Bad News: Diagnostic Problems

The Bad News:
Diagnostic Problems

eGFR is an estimation and is less accurate than the measured GFR (mGFR), which can also cause false-positive and false-negative results.6,7,10,13

Up to 30% of elderly whom are considered “healthy” (mGFR within normal limits, and no indication of kidney disease) are inaccurately identified as having a low GFR by eGFR equations.7

eGFR can estimate a patient’s renal function at that moment in time, so an abnormal test result does not tell the physician if the kidney damage is recent, occurred over weeks to months, or is chronic disease.4-6

Failure to adhere to the timely 3-month requirement leads to a false positive rate of 30-35%7,13 

{

Troubling Accuracy

A first-time low eGFR value has a LOW single assessment accuracy:

Positive Predictive Value (PPV): 7,13
0%
(Probability that subjects with a positive screening test truly has the disease)
Sensitivity: 13
0%
}

{

Troubling Accuracy

A first-time low eGFR value has a LOW single assessment accuracy:

}
Positive Predictive Value (PPV): 7,13
0%
(Probability that subjects with a positive screening test truly has the disease)
Sensitivity: 13
0%
(If one has CKD, Current CKD tests will miss about 74% of those patients on the first assessment)

Meeting the current CKD diagnostic criteria requires at least two sequentially low eGFR values (<60 mL/min/1.73m2) at least 3- to 6-months apart.

  • Serum creatinine is a by-product from the muscles, and although it is considered to be “freely filtered” by the kidney, it does not originate from the kidney, which makes this a non-specific biomarker for kidney disease.
  • eGFR normalizes a patient’s body surface area to the average adult human, so test results can often be inaccurate for atypically large or small people.
  • Serum creatinine can be falsely increased or decreased by uncontrollable patient variables such as the following4-8:
        1. Increased muscle mass or a large body habitus
        2. Various medications
        3. Hydration status
        4. Elderly age
        5. Contrast agents, generally used for imaging tests
        6. Sensitivity: 20% – 28% (depending on age)13

Meeting the current CKD diagnostic criteria requires at least two sequentially low eGFR values (<60 mL/min/1.73m2) at least 3- to 6-months apart.

  • Serum creatinine is a by-product from the muscles, and although it is considered to be “freely filtered” by the kidney, it does not originate from the kidney, which makes this a non-specific biomarker for kidney disease.
  • eGFR normalizes a patient’s body surface area to the average adult human, so test results can often be inaccurate for atypically large or small people.
  • Serum creatinine can be falsely increased or decreased by uncontrollable patient variables such as the following4-8:
  1. Increased muscle mass or a large body habitus
  2. Various medications
  3. Hydration status
  4. Elderly age
  5. Contrast agents, generally used for imaging tests
  6. Sensitivity: 20% – 28% (depending on age)13

The Good News: Our Solution

The Good News:
Our Solution

The lack of efficient, timely, accurate, and reliable diagnostic testing methods for CKD is a critical problem recognized by the CDC, ASN (American Society of Nephrology), NKF (National Kidney Foundation), NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases at NIH), ISN (International Society of Nephrology), and ERA-EDTA (European Renal Association-European Dialysis and Transplant Association).1-3

Our company will help provide a solution to this worldwide epidemic by offering an innovative diagnostic test that is highly accurate (>97%*) for chronic kidney disease on a single assessment.

1 %*
SENSITIVITY
> 1 %*
Specific
1 +*
Days FASTER

SEQUELA's New CKD Diagnostic Test

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