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National, Universal Living Donor Kidney Registry and At-Home Living Donor Testing Kit: Interview with David Fleming, President and CEO of DLA

December 2nd, 2019 Conn Hastings Exclusive, Urology

The Fresenius Medical Care Foundation (FMCF), which is the nonprofit arm of Fresenius Medical Care North America (FMCNA), has teamed up with Donate Life America (DLA), another non-profit, to create a universal living donor kidney registry and at-home living donor testing kits.

Approximately 30 million people in the United States are affected by kidney disease, with another person being added to the kidney transplant waiting list every ten minutes. At present, the majority of kidney transplants are possible because of deceased donors, but there is a shortage of such donors leading to increased wait times for those needing a transplant. In fact, there are approximately 95,000 people on the transplant waiting list.

Another option involves living donors providing a kidney, and such transplants often have better outcomes than those performed with a kidney from deceased donors. The public has expressed interest in acting as living donors, but there is currently no way for them to register their interest and find a match in terms of a suitable recipient for their donated kidney.

To address these issues, this new collaboration intends to introduce the first national living donor registry, where those interested in acting as a donor can register their intent. In addition, the plan involves providing potential donors with at-home test kits so that they can test their saliva and find a potential kidney recipient match as soon as possible. The test should streamline the process and help to reduce waiting times for those needing a transplant.  

Medgadget had the opportunity to talk to David Fleming, President and CEO of DLA, to discuss the partnership.

Conn Hastings, Medgadget: Please give us an overview of the current issues facing those needing a kidney transplant.

David Fleming, Donate Life America: An estimated 30 million Americans have kidney disease—and that number is expected to grow with an increasingly at-risk population. Kidney transplantation is the best option for eligible patients living with kidney failure. 95,000 people are currently on the kidney transplant waiting list – and another person is added approximately every ten minutes. The need is clear, and solutions will call for systemic collaboration and innovative partnerships to increase the number of transplants for people living with kidney disease.

Medgadget: Please give us an overview of the partnership between Fresenius Medical Care Foundation (FMCF) and Donate Life America (DLA). How did the partnership come about, and what benefits will it provide for patients with kidney disease and prospective living donors?

David Fleming: The recent Fresenius Medical Care Foundation (FMCF) grant to Donate Life America (DLA) is one of the innovative partnerships that will help to increase lifesaving kidney transplants. DLA is committed to educating the public about the need for donation and bringing deceased and living donation registration opportunities to more people. Without the generosity of the donor, there is no transplant. The FMCF is focused on transplant and on improving lives by raising awareness of kidney disease and igniting the advancement of lifesaving solutions.

As we talked, we knew that in order to increase living donation we needed a clear, consistent national call to action to register your interest in being a living donor. We know there is public interest in living donation, and we need to make it an easy, intuitive process for them to get more information.

FMCF, the nonprofit arm of Fresenius Medical Care North America (FMCNA), has given $500,000 to DLA to launch two new initiatives focused on living donation in 2020:

First, a national, universal living donor registry that will offer the opportunity for the public to register their interest in becoming a living donor. This new registry will be built as part of the already existing, secure, and trusted National Donate Life Registry that houses deceased organ, eye and tissue donor registrations. Additionally, this platform will capture preliminary results from the new at-home testing kits and interface with the United Network for Organ Sharing (UNOS) to find lifesaving matches nationwide.

Additionally, DLA and FMCF will create a living donor testing kit to enable a faster, easier at-home screening option, vital to helping identify potential living donors for kidney transplant.

Medgadget: How does the new at-home living donor test work? Can users get an instant result at home, or will they send a saliva sample for analysis elsewhere?

David Fleming: Potential living donors who express interest in donating a kidney will be asked to complete a brief online health screening questionnaire, collect a sample using the at-home testing kit, and return the sample by mail for lab analysis.

Lab analysis will then determine the potential donor’s blood type and HLA typing; the test results and health information will be uploaded to a secure database and attached to the potential donor’s record in the registry. Once the potential living donor is accepted into a transplant program’s living donor process for their intended recipient, the transplant program will conduct a full medical evaluation and lab testing.

Medgadget: What are the advantages of living donors, compared with deceased kidney donations?

David Fleming: This year, an estimated 20,000 people on the kidney transplant waiting list will receive a kidney transplant, primarily from deceased donors. There is a shortage of deceased donor kidneys to meet the needs of those waiting for a second chance at life. Only 1% of all deaths in the U.S. are eligible to be organ donors. Increasing donor registrations for deceased and living donation – and increasing the number of living kidney donors are the best options to save more lives. Living donor kidneys demonstrate higher post-transplant success rates than deceased donor kidneys, according to United States Renal Data System (USRDS) data. Additionally, waiting times can be shorter with living donation. The average waiting time for a deceased donor kidney transplant is 3-7 years. For living donor kidney transplants, it can be one year or less. This is critical for patients awaiting lifesaving transplants.

Medgadget: How will the new living donor registry facilitate living donors in matching with a transplant patient?

David Fleming: This platform will capture preliminary results from the new at-home testing kits, and in partnership with the United Network for Organ Sharing (UNOS) and transplant programs across the country, will allow potential living donors and recipients to find matches nationwide. This new National Donate Life Living Donor Registry will be an extension of our existing National Donate Life Registry, a secure mobile optimized deceased organ, eye and tissue donor registry. The public will now be able to add their registered interest in being a living donor to their individual donor record.

Medgadget: When will the registry and at-home test roll out?

David Fleming: We will be running pilot programs in early 2020 ahead of a national roll-out in the Spring and five transplant programs across the U.S. will be participating in this pilot program.

The institutions participating in the pilot program will implement the use of the testing kits by sharing them with their current living donor transplant candidates to share with their personal networks and help identify potential living donors across the U.S. The potential living donors will register through the National Donate Life Living Donor Registry. The initial test kit samples will be evaluated, results will be collected, and UNOS will use the results to identify potential matches and communicate back to the pilot transplant programs.

Link: Donate Life America homepage…

Conn Hastings

Conn Hastings received a PhD from the Royal College of Surgeons in Ireland for his work in drug delivery, investigating the potential of injectable hydrogels to deliver cells, drugs and nanoparticles in the treatment of cancer and cardiovascular diseases. After achieving his PhD and completing a year of postdoctoral research, Conn pursued a career in academic publishing, before becoming a full-time science writer and editor, combining his experience within the biomedical sciences with his passion for written communication.

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