LIVING life through diagnostics: What I learned from speaking with a kidney transplant recipient
Precision diagnostics aim to improve patient diagnosis, optimize drug treatment selection, reduce unnecessary exposure to toxic side effects, and ideally help cut healthcare expenditure. The utility of such a diagnostic product is demonstrated by shortened time to a confirmatory diagnosis, improved overall survival, and reduced hospitalization as examples. While these are undoubtably helpful metrics, I believe that the real impact of a precision diagnostic is best measured on an individual level with direct feedback from patients themselves.
Olaris is poised to launch myOLARIS™-KTdx, a precision diagnostic using metabolomics to identify kidney transplant (KT) patients at risk for complications associated with over-immunosuppression. All transplant recipients must take immunosuppressant (IS) drugs so that their bodies don’t reject the new organ—but those same drugs working to save the graft can weaken the immune system, putting patients at risk for infection, malignancy, and other complications. In fact, infection is the 2nd leading cause of death for KT recipients in the first year (1), and KT recipients are 200 times more likely to develop cancer (2). Finding the right balance of IS for a KT patient is a longstanding unmet clinical need. The myOLARIS-KTdx test aims to solve this—using only a urine sample, we can determine with high accuracy if a patient is at risk for over-immunosuppression and provide confidence when the right dose of drug for a stable graft has been achieved. During product development, we have talked to dozens, if not hundreds, of physicians across the globe and had a 100% confirmation rate that this type of precision diagnostic is absolutely needed in real-world clinical care and could dramatically improve patient management. This is great news, but the most encouraging feedback came from listening to and learning from a KT recipient about what her day-to-day is like managing her health.
Last Friday, I had the chance to speak to Kara B, a 34-year-old daughter, sister, aunt, friend, and a two-time KT recipient. Kara was born with Branchiootorenal (BOR) syndrome, a rare genetic disease that affects 1 in every 40,000 people and disrupts the development of tissue in neck and causes malformations in the ear and kidney (3). In Kara’s case, it led to an underdeveloped kidney, and by age 10, she had her first living donor KT from her dad. Everyday thereafter, she had to take heavy doses of immunosuppressants, totaling 15-20 pills a day. That’s a lot to manage, but Kara recalls - giving credit to her parents and family - having a normal childhood. At age 19, like so many 19-year-olds, she felt “good” and became a bit lax with her medication. Unfortunately, this led to a massive a rejection episode, resulting in hospitalization, and while physicians were able to stabilize her, chronic rejection of her kidney ensued. She resumed heavy doses of IS drugs, and during this time, Kara developed a benign brain tumor that led to 3 different surgeries, ultimately affecting her speech. UTIs and other infections had her in and out of the hospital throughout the following years. While this was going on, it became clear that Kara would need another KT, and this time, her sister was the living donor. A perfect match, hopes were high, but within the 1st month post-transplant, Kara was rushed to the hospital semi-unconscious with a high fever, where it was determined she had a parvovirus infection. Once again, her clinicians were able to stabilize her, but a lot of trial and error was used in finding the right dose of IS. Because she is so prone to infection, she is now on the lowest dose of drugs she has ever been on. Even so, she just had an Epstein-Barr virus (EBV) flare-up, but her doctors don’t want to lower the therapy dose as it could induce rejection.
Despite all of these trials, in speaking with Kara, I was overwhelmed by how undeniably fun she is—somehow, and a true testament to her character, our conversation was filled with laughter. As we both described our weekend plans - me playing with my daughter, and she is playing with her new niece - in some many ways Kara is just like any other 30-something year old female. And that’s how it should be!
Yet trying to find the right balance of IS has been an ongoing struggle for Kara, with numerous biopsies, constant tests, and seeing a nephrologist every 3 months for almost the entirety of her life. I know there is a better option, and it’s the principle on which Olaris is centered. All of our myOLARIS diagnostics aim to remove the guesswork from medicine and provide individuals confidence to live their lives. The myOLARIS-KTdx test is a non-invasive urine test that enables early detection of complications for KT patients, but it also - and perhaps more importantly – can provide confidence when the right balance of IS has been reached. Hearing Kara’s story, I could see exactly how our test could have been a powerful resource for her: avoiding biopsies and trips to the hospital or seeking medical attention sooner. Kara just celebrated 7 years with this new kidney. With improved diagnostics, we both have high hopes – not only for many more years with the kidney but for years with less tests, less anxiety, and simply living.
References:
1. Hariharan S, Israni AK, Danovitch G. Long-Term Survival after Kidney Transplantation. N Engl J Med. 2021 Aug 19;385(8):729-743. doi: 10.1056/NEJMra2014530.
2. Engels EA, Pfeiffer RM, Fraumeni JF, et al. Spectrum of Cancer Risk Among US Solid Organ Transplant Recipients. JAMA. 2011;306(17):1891–1901. doi:10.1001/jama.2011.1592
3. Kochhar A, Fischer SM, Kimberling WJ, Smith RJH. 2007. Branchio-oto-renal syndrome. Am J Med Genet Part A 143A:1671–1678. doi: 10.1002/ajmg.a.31561