By Turna Ray
Geneuity Clinical Research Services has recently validated and launched two assays that it said can screen patients for kidney damage from drugs in various stages of clinical development.
The assays measure urine biomarkers — NGAL (neutrophil gelantinase-associated lipocalin) and KIM-1 (kidney injury molecule 1) — that will help drug developers gauge the right dose for drugs in Phase I trials, validate proof-of-concept in Phase II, and confirm the efficacy and safety of compounds in Phase III studies by helping avoid kidney damage in participants, the company said.
A year ago, the US Food and Drug Administration and the European Medicines Agency agreed to accept data for seven kidney toxicity biomarkers found in urine as part of the drug approval process. KIM1 is among the seven biomarkers the agencies will accept, along with albumin, total protein, β2-microglobulin, cystatin C, clusterin, and trefoil factor-3.
NGAL, although a biomarker found in urine indicative of drug-related kidney damage, is not among the seven markers accepted by the FDA and EMEA.
"Rapid, cost-effective biomarker analysis is critical to pharmaceutical and biotechnology companies for enhancing discovery to market performance," Geneuity said in a statement. "Screening patients enrolled in early-phase clinical trials for kidney damage due to drug toxicity is of particular importance, as drug concentration in the kidney is 1,000-fold higher than in circulating plasma."
According to Geneuity, both NGAL and KIM-1 can detect potential drug-induced damage to kidney cells in human clinical trials at "a much earlier stage of renal toxicity" than traditional markers used to detect kidney damage, such as nonspecific BUN (blood urea nitrogen) and other serum creatinine markers.
In addition to increased sensitivity of these biomarkers, NGAL and KIM1 have expression patterns that allow researchers to pinpoint where in the kidney the drug is damaging tissues. By comparison, BUN and creatinine provide no insight into the specific regions of drug-induced kidney damage.
According to Genuity, "in addition to use in clinical trials, NGAL and KIM1 levels are predictive for graft function after renal transplant and for assessing the duration and severity of kidney damage resulting from diseases such as diabetes, viral infection, autoimmune conditions and hypertension."
Geneuity, a division of Molecular Pathology Laboratory Network, is certified under the Centers of Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments, is accredited by the College of American Pathologists, and is licensed by the states of New York, Florida, Tennessee, and Maryland.