APOL1 Genotyping Program

This new, no-cost program informs eligible patients of their risk of a rapidly progressive form of chronic kidney disease.

Vertex Pharmaceuticals is sponsoring this genotyping program in collaboration with Labcorp, who will perform APOL1 genotyping and genetic counseling for eligible patients at no cost.

Kidney failure occurs in African Americans about three times as often as it does in white Americans.1

Research has shown that one of the causes of increased risk of kidney disease in African Americans may be driven by genetic changes, known as “risk variants” in the APOL1 gene.2,3 Participation in this program can help you learn more about the APOL1 genetic status of your eligible patients.

What is APOL1-mediated kidney disease (AMKD)?

Did you know?

The APOL1 gene is part of a gene family that plays a role in the body’s immunity. We all have this gene, and it is present in tissues throughout the body, including the kidneys. 

APOL1-mediated kidney disease (AMKD) is a rapidly progressive form of proteinuric non-diabetic chronic kidney disease. This genetic disease is caused by two variants of the APOL1 gene and a “second hit” (such as infection or inflammation).3

AMKD is characterized by:

  • Proteinuria: Ranges from subnephrotic to nephrotic presentation.1
  • Early onset: Most patients are age 50 or younger. Some even present as children.4
  • Lack of symptoms: Often not visible to the patient until the disease is advanced.2
  • Rapid progression: Patients with two APOL1 risk variants typically progress to kidney failure 7 to 9 years earlier than those without.5
  • Other factors: Hypertension or a family history of kidney disease.1

What is this program?

The APOL1 Genotyping Program is offered through a partnership between Vertex Pharmaceuticals and Labcorp to provide increased access to testing for patients who are at a higher risk for AMKD.   

This program can help inform you of what is causing your patient’s non-diabetic kidney disease before attributing it to other causes, like high blood pressure, as well as provide more information for your patients.

Once you’ve signed up for the program, you will be able to order APOL1 single gene testing for eligible patients at no cost.

Eligible patients will also be provided access to genetic counseling at no cost*.

Who is eligible?

APOL1 risk variants occur in people of African ancestry including those who self-identify as Black, African American, African or Afro-Caribbean. It’s important to think broadly about ancestry since many people aren’t certain about their genealogy.  

Patients must meet all of the following criteria to be eligible: 

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Is of African ancestry

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Has a diagnosis of non-diabetic chronic kidney disease  

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Has no history of kidney transplant 

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Has no history of dialysis  

Geographic limitations may apply.

Portrait of cheerful businesswoman looking out window in conference room
Video shown with permission from American Kidney Fund

Why test eligible patients for APOL1?

Experts recommend testing patients of African ancestry with kidney disease and those with a family member with a high-risk APOL1 genotype.1

  • Knowing the cause of CKD can help guide treatment decisions.
  • Patients who test positive are at an increased risk of AMKD, a progressive form of kidney disease.6,7
  • Proper diagnosis can help provide the most informed disease management.

A definitive diagnosis of AMKD can better inform patient management

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Provide a clearer prognosis: You can help your patient understand their prognosis and provide more frequent monitoring.1

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Guide treatment decisions: A proper diagnosis can help guide decisions about monitoring and treatment. (For example, these patients are more likely to be resistant to steroid treatment.)8

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Open up clinical trial options: While there are no approved treatments to alter the course of disease progression today, investigational drugs are in clinical development. A diagnosis may lead to new clinical trial options.3

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Empower patients: Reassure patients that they are not to blame for their CKD, motivate them to live a healthier lifestyle, and use the information for things like family planning and other considerations.1

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Empower families: The awareness of genetic disease in one family member may enable another family member to seek their own APOL1 status.1

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Provide support, resources and training: Genetic counseling can help patients better understand their diagnosis and the implications.

How to participate


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1

Sign up

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Order test

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Get results

Getting started

Complete the brief sign-up form and our Clinical Program Coordinator will reach out with a Welcome Packet and Test Request Form (TRF). Our coordinator will be there to guide you through setup and answer any questions. Test results will be delivered through your standard Labcorp reporting method within approximately two weeks.

Our Clinical Program Coordinator will help guide you through the setup and testing process.

Program is sponsored by Vertex Pharmaceuticals and is available at no cost* to eligible** patients.

*Vertex Pharmaceuticals is sponsoring this APOL1 Genotyping Program in collaboration with Labcorp, who will perform APOL1 genotyping and make genetic counseling available for eligible patients at no cost.

**Eligible patients are those of African ancestry who may self-identify as Black, African American, African, or Afro-Caribbean. Patients must have a diagnosis of chronic kidney disease, no history of kidney transplant, not have diabetes and must not be currently being treated with dialysis.

References: 1. Freedman BI, Burke W, Divers J, et al. Diagnosis, education, and care of patients with APOL1-associated nephropathy: a Delphi consensus and systematic review. J Am Soc Nephrol. 2021;32(7):1765-1778. doi:10.1681/ASN.2020101399 2. Understanding APOL1 kidney disease among Black Americans. NephCure Kidney International. https://nephcure.org/understanding-apol-kidney-disease-among-black-americans/ 3. Friedman DJ, Pollak MR. APOL1 and Kidney Disease: From Genetics to Biology. Annu Rev Physiol. 2020 Feb 10;82:323-342. doi: 10.1146/annurev-physiol-021119-034345. 4. Ng DK, Robertson CC, Woroniecki RP, et al. APOL1-associated glomerular disease among African-American children: a collaboration of the Chronic Kidney Disease in Children (CKiD) and Nephrotic Syndrome Study Network (NEPTUNE) cohorts. Nephrol Dial Transplant. 2017;32(6):983-990. doi:10.1093/ndt/gfw061 5. Elliott MD, Marasa M, Cocchi E, et al. Clinical and Genetic Characteristics of CKD Patients with High-Risk APOL1 Genotypes. J Am Soc Nephrol. 2023 May 1;34(5):909-919. doi: 10.1681/ASN.0000000000000094. 6. Friedman DJ, Pollak MR. APOL1 nephropathy: from genetics to clinical applications. Clin J Am Soc Nephrol. 2021;16(2):294-303. doi:10.2215/CJN.15161219 7. Kopp JB, Winkler CA. Genetic testing for APOL1 genetic variants in clinical practice: finally starting to arrive. Clin J Am Soc Nephrol. 2020;15(1):126-128. doi:10.2215/CJN.01810219 8. Rovin BH, Adler SG, Barratt J, et al. Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4):753-779. doi:10.1016/j.kint.2021.05.015