A major breakthrough for Americans on the brink of kidney dialysis

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Some 100,000 Americans are placed on kidney dialysis and the transplant list every year in the U.S.

Rich Pedroncelli | AP

Medical experts are hoping 2020 will mark a turning point in the fight against kidney disease in America, thanks to advancing technology. Currently, the U.S. spends about $100 billion annually to treat the nearly 40 million Americans suffering from chronic kidney disease who need dialysis and organ transplants. The public health crisis, exacerbated by the rise in obesity and type 2 diabetes, is now the ninth leading cause of death in the nation, according to the Centers for Disease Control and Prevention.

President Donald Trump’s Advancing American Kidney Health Initiative, launched in July, was a nod that this is one area of medicine in urgent need of innovation. The new plan calls for the CDC to improve kidney disease tracking and detection nationwide. It also calls for a change in Medicare provider payment models to prioritize preventive care from doctors, develop effective home-care dialysis and find ways to boost organ supply — including encouraging the development of an artificial kidney.

President Donald Trump displays an executive order he has just signed during an event on kidney health at the Ronald Reagan Building and International Trade Center on July 10, 2019, in Washington, DC.

Alex Wong | Getty Images

One company making inroads in the field is RenalytixAI, an AI clinical diagnostics company for kidney disease. It has received an FDA breakthrough device designation for its KidneyIntelX, an AI-powered diagnostic product for kidney disease that is expected to launch in the second quarter of this year in the U.S.

The diagnostic — developed in collaboration with the Mount Sinai Health System in New York City, which has 3 million patient health records and 52,000 biobank participants — uses machine learning algorithms to assess the combination of blood-based biomarkers and electronic health records information and other genomic information to identify progressive kidney disease in patients. From this collection of data, the company aims to build new models to predict kidney disease progression and how a given patient might respond to a treatment.

In addition, it has developed FractalDX, a lab-based AI tool that can predict the risk of adverse transplant outcomes, including early kidney rejection.

“This is an epidemic, and it is a silent killer, since symptoms don’t appear until the disease is in the final stages and a patient needs dialysis and transplantation,” says James McCullough, CEO of RenalytixAI. “Just look at the numbers — they are staggering. Some 100,000 Americans get put on kidney dialysis and the transplant list each year.” 

Despite the rising trend, there is an organ donor shortage in the U.S. Last year there were only about 21,000 donor organs available for transplant, according to The Kidney Project, at the University of California in San Francisco. 

As a result, reveals data from Mount Sinai, 23% of people on kidney dialysis die every year.

Kidney transplant surgery.

BSIP | Universal Images Group | Getty Images

“Unfortunately, the disease is disproportionately hitting African and Hispanic Americans for two reasons,” points out Dr. Girish Nadkarni, co-founder of RenalytixAI and an assistant professor of nephrology at Mount Sinai. “Many people in these populations have a genetic mutation of the APOL1 gene. In addition, because of socioeconomics, many don’t have access to healthy food, and other poor socioeconomic conditions.”

This is an epidemic, and it is a silent killer, since symptoms don’t appear until the disease is in the final stages and a patient needs dialysis and transplantation.

James McCullough

CEO of RenalytixAI

Recognizing this problem, the Centers for Medicare and Medicaid Services has set a national price and reimbursement code for the KidneyIntelX test at $950, effective until December 2022, and the American Medical Association has provided a CPT reimbursement code. This should accelerate private insurers to provide coverage for the test.

Dr. Chirag Parikh, chief of nephrology at Johns Hopkins and a board member of RenalytixAI, is excited by the prospects of the new technology and other innovations in the field that are beginning to bubble up in the community. “In my 25-year career, I have never seen such a confluence of factors converging to bring about advances in the field.” He pointed to public-private partnerships such as the KidneyX incubator — a partnership between HHS and the American Society of Nephrology — that’s trying to reinvent kidney dialysis treatment.

Globally, kidney disease affects more than 850 million people, making its early detection crucial. It’s a huge market that needs disruption, and companies such as Google are looking at finding ways to use AI to tackle the problem.

Last year DeepMind, now part of Google Health, unveiled an algorithm that predicts acute kidney injuries in patients who would end up needing dialysis 48 hours before many symptoms can be recognized by doctors. The work was the result of a project with the U.S. Department of Veteran Affairs.

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