The Market – Food Safety
Gluten-free food is not just for celiacs
The demand for food screening is growing by over 10% a year due to the preponderance of the population pursuing healthy diets and the belief that reduced gluten consumption is a healthy trend. According to recent gluten-free market trends well over 15% of consumers are eating gluten-free as part of a healthy lifestyle far outnumbering those due to dietary restrictions. Sales of gluten-free food have doubled in the last five years and are expected to reach $5.5B by 2015. Despite growing evidence that non-celiacs do not necessarily benefit from gluten-free foods, the market demand continues to grow.
Regulations and current screening methods
The World Health Organization (WHO) and the U.S. Federal Drug Administration (FDA) have set standards for labeling food as gluten-free as containing no more than 20 ppm by mass of gluten protein. This value is based more on existing method detection limits than on what truly constitutes safe gluten levels for celiacs.
There are only a few suppliers of ELISA kits that have been endorsed by the AOAC and/or AACC, for detection of wheat gluten proteins in the food industry. The R5 antibody ELISA kit detects the QQPFP toxic epitope in prolamin proteins, but in the native state only. The more recently endorsed G12 antibody ELISA kit, detects an epitope from a toxic 33-mer peptide sequence. These kits are currently the best available, but suffer from several deficiencies including that they target a very limited range of protein allergens and are only truly effective for natural, non-processed foods whose protein content has not been altered.
ImmunogenX competitive advantage and approach
Dr. Sealey-Voyksner, Co-founder of ImmunogenX has pioneered the use of liquid chromatography 2D mass spectrometry (LC-MS/MS) methods combined with a physiologically relevant proteolytic digestion method to unambiguously identify and sequence key new toxic gluten peptide epitopes. Detection and quantitiation sensitivities are well below 1 ppm.
The goal of ImmunogenX is to introduce the LC-MS/MS method as a multiplexed diagnostic method providing much better quantitation of gluten content in food compared to existing ELISA methods.