Frequently Asked Questions
What is meant by 97% accuracy?
Preliminary clinical trials involving 320 subjects demonstrated the following results for Sequela’s CKD Test on a single assessment:
- Sensitivity: 99%
- If one has CKD, Sequela’s test will only miss about 1% of those patients on the first assessment.
- Specificity: >96%
- If one does not have CKD, Sequela’s test will have a false-positive result <4% of the time on the first assessment.
- Accuracy: >97%
- A statistical representation of the ROC analysis that incorporates false-positive and false-negative data using hundreds of human clinical samples.
Should I be concerned about the health of my kidney’s? Is the CKD-Assay meant for me?
Sequela’s CKD Test is meant for individuals who have a co-existing or another indication that places one at high risk for kidney disease.
Find out if you are one of the millions of people at risk by visiting our Kidney Disease fact page.
Can my doctor currently order this test for me in the clinic?
No, not currently. This product has not yet been reviewed by the FDA and all clinical trial results are preliminary.
Sequela is currently completing studies for the FDA and trials to obtain insurance coverage to make this test easily accessible to physicians across the world.
What stages will the Sequela’s new test for kidney disease be able to detect?
CKD Stage 3a, 3b, 4, 5, and end-stage renal disease (ESRD). Results will be reported as either a positive or negative result in a single-assessment.
GENERAL FAQ
What is the CKD Assay ™?
:
An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte). The analyte can be a drug, biochemical substance, or cell in an organism or organic sample. The measured entity is often called the analyte, the measurand, or the target of the assay. An assay usually aims to measure an analyte’s intensive property and express it in the relevant measurement unit (e.g. molarity, density, functional activity in enzyme international units, degree of effect in comparison to a standard, etc.).
Is Sequela’s new diagnostic test for kidney disease currently available?
Not yet, the diagnostic test is currently under FDA review, as such, claims are subject to change based on the finalized product.
What is the platform used by Sequela to acurrately diagnose kidney disease in a single assessment?
If you wish to know more about Research and Development at Sequela Biotech, Contact Us today.
When will Sequela’s new diagnostic test for kidney disease be available for patients everywhere?
The CKD-Assay will be available to physicians in early- to mid-2021. Contact Us below for more information.
CHRONIC KIDNEY DISEASE
What is meant by 97% accuracy?
Preliminary clinical trials involving 320 subjects demonstrated the following results for Sequela’s CKD Test on a single assessment:
- Sensitivity: 99%
- If one has CKD, Sequela’s test will only miss about 1% of those patients on the first assessment.
- Specificity: >96%
- If one does not have CKD, Sequela’s test will have a false-positive result <4% of the time on the first assessment.
- Accuracy: >97%
- A statistical representation of the ROC analysis that incorporates false-positive and false-negative data using hundreds of human clinical samples.
Should I be concerned about the health of my kidney’s? Is the CKD-Assay meant for me?
Sequela’s CKD Test is meant for individuals who have a co-existing or another indication that places one at high risk for kidney disease.
Find out if you are one of the millions of people at risk by visiting our Kidney Disease fact page.
Can my doctor currently order this test for me in the clinic?
No, not currently. This product has not yet been reviewed by the FDA and all clinical trial results are preliminary.
Sequela is currently completing studies for the FDA and trials to obtain insurance coverage to make this test easily accessible to physicians across the world.
What stages will the Sequela’s new test for kidney disease be able to detect?
CKD Stage 3a, 3b, 4, 5, and end-stage renal disease (ESRD). Results will be reported as either a positive or negative result in a single-assessment.
