LexaGene’s fully automated pathogen detection platform aims to provide food processors a 21st century solution to their problem by delivering an on-demand system capable of screening for many pathogens at a time, and returning results in one hour.
America’s food industry has a $55.5 billion safety problem.1 Food poisoning causes approximately 48 million illnesses, over 127,000 hospitalizations, and over 3,000 deaths per year in the United States.2 The food testing market is expected to grow to $4.63B in 2018 with over 2.62B tests performed per year.3 A single food recall can cost as much as $100M in losses and cause irreparable damage to a company’s image.4
Despite the high consequences of food recalls, their frequency has not significantly diminished for decades due to the industry’s reliance on a slow, antiquated method of pathogen detection that is prone to sampling errors, and takes 24-48 hours to generate results. See current method vs. LexaGene food safety testing.
Food Safety Opportunity
LexaGene sees an opportunity to provide on-site automated testing to reduce the time required for food producers to ship their products to consumers. This market is not served by competitor products, as they are unable to process large volumes of sample, which is required to detect ultra-rare pathogens, nor are they able to offer molecular testing at a cost that is acceptable for this industry.
LexaGene believes this market is ready to adopt new technologies as the FDA is now rolling out new regulations due to the recent update to the Food Safety Modernization Act (FMSA), which requires food producers to actively prevent outbreaks rather than simply have a plan to respond to them.5
Mandatory Testing Now Required
2010: Congress passed the Food Safety Modernization Act (FMSA)
2015: FDA announced new FSMA rules to be rolled out 2016-2018
Previously: Only required to respond to an outbreak
Now: Required to prevent an outbreak
- FDA inspects at least once per 3 years (was once per 10 years)
- Auditors will also inspect foreign food suppliers
- Food Safety Plan
- Methods of keeping food clean
- Methods of testing food
- Method for recording testing results
- Corrective action plan for dealing with a contamination
LexaGene’s technology is disruptive to the food safety testing marketplace, as it will change the method by which food is screened for pathogens.
1 J Food Prot. 2015 Jun;78(6):1064-71. doi: 10.4315/0362-028X.
2 Scharff, R.L., Economic burden from health losses due to foodborne illness in the United States. J Food Protection, 2012. 75(1): 123-131.