FDA Clears First Fully Automated Calprotectin Test for IBD Diagnosis, Inova Says

FDA Clears First Fully Automated Calprotectin Test for IBD Diagnosis, Inova Says

The U.S. Food and Drug Administration (FDA) has approved the QUANTA Flash Calprotectin test to help diagnose inflammatory bowel disease (IBD) and differentiate that disease from irritable bowel syndrome (IBS).

Developed by Inova Diagnostics, QUANTA Flash Calprotectin is the first fully automated, random access calprotectin assay given FDA approval. The test is an immunoassay designed to detect IBDs such as Crohn’s disease and ulcerative colitis in fecal calprotectin in human stool samples.

Neutrophils have high levels of calprotectin, a protein that binds to calcium and zinc. Neutrophils cause acute inflammation in response to a number of factors, meaning that the amount of calprotectin reflects the concentration of neutrophils in a given inflammation process. The significant correlation between fecal calprotectin and other measures of acute inflammation confirms this link in IBDs.

Moreover, calprotectin is resistant to degradation by intestinal pancreatic secretions, intestinal proteases and bacterial degradation, and is stable in feces at room temperature for at least seven days.

“Fecal calprotectin has revolutionized my clinical practice.  Calprotectin measurements during patients’ diagnostic workup when the diagnosis could be either IBS or IBD provide direction and important information prior to endoscopic evaluations,” Dr. KT Park, chair of clinical care and quality at Stanford University School of Medicine, said in a press release. “Calprotectin testing supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation.”

The FDA cleared one other assay from Inova, called QUANTA Lite Calprotectin Extended Range, in November 2016. This was also to diagnose IBD and to help differentiate it from IBS.

Like QUANTA Flash Calprotectin, QUANTA Lite detects concentrations of fecal calprotectin to aid diagnosis of IBDs. However, the quantitative enzyme-linked immunosorbent assay (ELISA) relies on different technology.

The two FDA approvals follow a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE), confirming the benefits of fecal calprotectin testing.

QUANTA Flash Calprotectin is among the 29 cleared assays available on BIO-FLASH, a random access chemiluminescent instrument for labs that delivers results in as little as 30 minutes.