Mahni Ghorashi, Clear Labs' co-founder, said that the development of its Clear Safety platform – based on Next Generation Sequencing (NGS) - represents a “vast improvement” over existing polymerase chain reaction (PCR) testing.
“One of the biggest upsides with NGS is that you don’t have to do different tests for each pathogen, as with PCR. Instead of just one answer at a time, you can ask almost infinite questions about a sample and get the answers all in one test. Clear Safety enables multi-target analysis, which increases throughput and reduces costs by screening an array of pathogens in the same or different matrices in parallel.”
It is also more accurate than other testing methodologies, he told FoodNavigator.
“Existing PCR methods have high rates of false negatives and false positives. Our NGS-based platform boasts an accuracy of 99.9%, which sharply reduces false positive and false negatives. Not only is this important from a food safety standpoint, it also has big risk and cost repercussions.
“A false negative means that the test comes out clean, but there’s actually a pathogen there. That’s an outbreak waiting to happen, and the average cost of a recall is about $10m (€8.5m). A false positive means you’re basically chasing a ghost. You think there’s something there, but there’s not. That translates into very high operational costs, because then you have to hold inventory, waiting to get the results back to see if the sample is indeed contaminated or not.”
Advanced pathogen profiling
Clear Safety is also the first platform to allow for “tunable” pathogen profiling, meaning you can set the level of molecular characterisation based on the information you need for your safety program.
“From strains to serotypes to whole genome sequences, food safety professionals get all the resolution they need in a single test,” Ghorashi asserted.
Robotics and automation are also utilised to reduce the potential for error and ensure tests can be reproduced.
“At its core, our platform is and has always been based on NGS technology paired with robust bioinformatics. It has always been backed by the world’s largest reference database for genomic food markers and food sample metadata.
“Over the last year and a half, we’ve built in features, including robotic automation, into the core platform to allow our system to be deployed on site and at high testing volumes. That is, we can leverage the benefits of NGS, at scale.”
Tests can be carried out on site or at a third-party microbiology lab and results are delivered within 24-hours.
“Perhaps what we’re most proud of is that we’ve accomplished this at the same price point and better turnaround time (24 hours or less) than PCR, with far greater functionality that make it really much more powerful for food companies,” Ghorashi claimed.
‘A new era in food safety’
The company founder predicted that Clear Safety will “absolutely” act as a disruptor in the food safety testing market
“Clear Safety marks the beginning of NGS 2.0, a new era in food safety. Discussion around NGS in our industry has often referred to Whole-Genome Sequencing, but that’s only a small part of what modern NGS systems can do and in fact, WGS is one of the oldest applications of NGS.
“With Clear Safety, we’re introducing the first NGS-based platform that can perform fast, accurate and high-volume pathogen tests.”
Having secured “acceptable cost at high volumes” Gnorashi said he expects NGS-based technologies like Clear Safety will “replace” legacy systems in less than five years.
“This is about so much more than a product or a technology; we want to help the world’s leading food brands and testing companies be on the forefront of the shift towards stronger and more proactive food safety programs. Our goal has always been to make our global food systems safer. We’re making good on that promise in a meaningful way with Clear Safety.”