Chronic kidney disease (CKD), often referred to as a “silent disease,” has been increasing in incidence around the world. Each year, kidney disease kills more people than breast or prostate cancer, and currently the prevalence of CKD in the general population is approximately 14 percent.
Kidney disease has no symptoms in its early stages and can go undetected until it is very advanced. Frequently, CKD is discovered only during urinalysis that shows the kidney is excreting protein or red blood cells into the urine.
A need exists for a simpler, less expensive, diagnostic tool, especially one useful for early stages of the disease when treatment and management may be most effective.
LIMR inventors developed a methodology for diagnosing kidney disorders such as autosomal-dominant polycystic kidney disease (ADPKD), CKD, kidney dysfunction, and preeclampsia in a urine sample. This methodology may be used as the basis for a lateral strip-type test, commonly used in the doctor’s office or at home.
In previous studies, LIMR investigators discovered that the presence of the RhoB protein results in increased severity of chronic inflammatory conditions, such as lupus and rheumatoid arthritis. Their studies showed that RhoB acts as a stress-response mediator that influences inflammatory signals.
Approximately 37 million U.S. adults have CKD — and nine out of 10 don’t know they have it, according to the U.S. Centers for Disease Control and Prevention. CKD is more common in people aged 65 years or older. Compared to Caucasians, the prevalence of end-stage renal disease is about 3.7 times greater in African Americans, 1.4 times greater in Native Americans, and 1.5 times greater in Asian Americans.
In recent years, there has been a substantial increase in the use of urinalysis, and that is expected to continue in the coming decade. While the annual global renal disease market is projected to reach US$133 million by 2023,  more specifically, the global urinalysis market is projected to reach US$4.6 billion by 2024, growing at a CAGR of 7.6% from 2019 to 2024. Experts have stated a market need for faster, less-expensive test kits.
Market growth is being powered by the increase in population suffering from kidney disease; the rising prevalence of diabetes and hypertension, which can impact renal health; and the rapid growth of the geriatric population around the world.
Because this invention enables the specific detection of a proinflammatory protein associated with the development of CKD, it offers a unique opportunity to develop a rapid, sensitive test that does not require specialized or expensive equipment for in-office or in-home personal care.
LIMR investigators devised a diagnostic reagent that comprises a ligand covalently linked to a detectable label or immobilized on substrate and is capable of specifically complexing with, binding to, identifying or quantitatively detecting a target within a RhoB protein.
This method enables the detection or measurement in the urine sample (or from a protein profile generated from the sample) of RhoB protein or peptide fragments. Comparing the protein level(s) of the RhoB protein or peptide fragments in the patient’s sample with the level of the same protein or peptide(s) in a reference may enable the diagnosis of ADPKD and other kidney diseases, or the identification of risk for developing those disorders. Inventors believe it also will enable clinicians to monitor the progression or remission of kidney diseases.
Stage of development
Early clinical stage of research and development.
- Compositions comprising ligands to RhoB protein and the uses thereof; PCT patent application.
- International patent WO 2018/213331.
Seeking licensee for commercialization or collaboration to complete assay development.
References and publications
Anti-RhoB antibodies: U.S. Patent No. 9,879,092 (issued Jan. 30, 2018).
Mandik-Nayak L, DuHadaway JB, Mulgrew J, Pigott E, Manley K, Sedano S, Prendergast GC and Laury-Kleintop LD. RhoB blockade selectively inhibits autoantibody production in autoimmune models of rheumatoid arthritis and lupus. Dis Model Mech. 2017;10:1313-22.
Almonte-Baldonado R, Bravo-Nuevo A, Gerald D, Benjamin LE, Prendergast GC and Laury- Kleintop LD (2018). RhoB antibody alters retinal vascularization in models of murine retinopathy. J Cell Biochem 294:4477.
Konvalinka A, Batruch I, Tokar T, et al. Quantification of angiotensin II-regulated proteins in urine of patients with polycystic and other chronic kidney diseases by selected reaction monitoring. Clin Proteomics. 2016 Aug 5;13:16.
Konvalinka A, Zhou J, Dimitromanolakis A, et al. Determination of an angiotensin II-regulated proteome in primary human kidney cells by stable isotope labeling of amino acids in cell culture (SILAC). J Biol Chem. 2013 Aug 23;288(34):24834-47.
- “Global Renal Disease Market,” Market Research Future, July 2019.
- “Urinalysis Market by Product,” Market and Markets, March 2019.