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FDA approves Inova Diagnostics’ new test for inflammatory bowel disease

MDBR Staff Writer Published 17 November 2016

The US Food and Drug Administration (FDA) has approved Inova Diagnostics' new test for inflammatory bowel disease (IBD).

The new Quanta Lite Calprotectin Extended Range assay will support in the diagnosis of IBD, in addition to differentiating IBD from irritable bowel syndrome (IBS).

The new test is a quantitative enzyme linked immunosorbent assay (ELISA), which detects calprotectin levels.

Physicians can obtain crucial information through accurate detection of calprotectin levels, helping them to provide better treatment for patients suffering from gastrointestinal disorders.

Inova Diagnostics research and development vice president Michael Mahler said: "We are very pleased to launch this high performing assay to meet the increasing demand from laboratories worldwide. Gastrointestinal pain is a common reason for seeking medical attention.

“Inaccurate diagnosis at the screening level can contribute to unnecessary procedures and increased healthcare costs. Quanta Lite Calprotectin Extended Range can improve care while helping reduce costs.”

In July, Inova Diagnostics received FDA approval for Quanta Flash connective tissue disease assays for use with the firm's Bio-Flash chemiluminescent analyzer for autoimmune testing.

Several Quanta Flash extractable nuclear antigen (ENA) assays are said to be used to diagnose connective tissue diseases (CTD) such as Systemic Lupus Erythematosus, Sjogren'sSyndrome and Systemic Sclerosis.

Inova Diagnostics is engaged in the development and commercialization of novel autoimmune technologies and diagnostic markers.