Sasan Amini is the co-founder and CEO of Clear Labs, which offers a next-generation sequencing platform for food safety testing.
When evaluating food safety solutions, accuracy should be the most important variable in the equation.
Polymerase chain reaction (PCR) and traditional culturing methods promise "good enough" results that are accurate most of the time. But when it comes to the risk of a recall, “most of the time” doesn't cut it.
Even a system that catches pathogens 98% of the time instead of more than 99.9% of the time has huge cost and reputational repercussions for a brand. Greater accuracy not only ensures companies have a better chance of catching pathogens and other contaminants before they reach consumers but also helps protect brands from the expensive consequences of both false negatives and false positives.
The risks of falling behind competitors grow as new technologies become available and are adopted by forward-thinking brands and food safety labs. These new technologies, detailed below, dramatically improve the accuracy of results with higher-resolution testing.
The real-world difference between 98% and 99.99%
In the U.S. alone, there are an estimated 47.8 million illnesses, more than 127,000 hospitalizations and 3,000-plus deaths attributed to foodborne illness each year. Salmonella alone accounts for 1 million foodborne illnesses each year to an overall economic cost of $2.65 billion per year, according to the Centers for Disease Control. Recalls caused by outbreaks cost on average $15 million per incident and cause significant harm to brands’ reputation and credibility.
That’s not to say nothing is being done – every single food safety professional I know is dead-set on reducing those numbers. We all aspire to reduce false positives and false negatives to as close to zero as possible. However, the tools with which we tackle some of these challenges have to be chosen purposefully so that legacy technology doesn’t hinder progress. Across the board, many see insurmountable barriers to upgrading or changing the solutions.
But the stakes are high. Even small differences in false positive and false negative rates – a few percentage points – can actually translate into a larger difference in the number of miscalled samples in high volumes.
Consider this: Of the estimated 280 million tests for pathogens in 2016, salmonella was the target in approximately 120 million tests, making up 43% of all food pathogen tests that year. In 2015, a study from the American Proficiency Institute on about 18,000 testing results from 1999 to 2013 for salmonella found false negative rates between 2% and 10% and false positive rates between 2% and 6%.
If you multiply the sheer volume of tests by incidence rate of salmonella and those accuracy rates, the difference of just a few percentage points creates a compounding effect that unnecessarily increases public health risks through elevated false negative results as well as brings potential costs to the bottom line and negatively impacts brand image through false positives that result in unnecessary but costly recalls.
Never again choose between good, fast and cost-effective
It’s common to hear that every purchase requires a compromise. You can’t have good, fast and cheap. You can only have two attributes of the three.
And for most industries, that’s enough. But when it comes to public health and safety, food safety professionals insist on all three and challenge the current status quo to drive down risks and keep the global supply chain running at the required scale. Fast, accurate and specific results can help identify the cause of a public health issue and cause a faster resolution
The technology capable of achieving all three today is a cutting edge and advanced method of next-generation sequencing (NGS) testing. This method looks at specific locations of the genome that are useful for identifying specific pathogens, covering more ground with a higher-resolution than traditional testing methods.
"Good," in the case of an NGS-based platform, means an accuracy rate of 99.9% and above, and very precise, targeted sequencing achieved through redundant genetic marker sequencing, bioinformatics and high sensitivity. Side-by-side studies of NGS with legacy technologies in the clinical space has proven technical advantages of NGS.
Fast means not just fast results, but improving overall time to deep molecular characterization and high confidence results and as a bonus adding much more value of information and data, an imperative in the fast-moving food supply chain. NGS matches and in some cases exceeds the turnaround time claims of legacy technologies like culturing and PCR by acting as a 2-in-1 test.
Due to the reduced cost of sequencing, high-volume NGS pathogen testing can match the cost of existing forms of testing, while adding much more value. For example, in addition to detecting pathogens in product, NGS enables the mapping of processes and environments from a preventative standpoint.
Updates now available in food safety platforms
With the emergence of technologies like NGS, there’s another reason to combat the status quo of “good enough” — the imperative of continuous improvement in today’s food safety environment.
One way in which this can be achieved is by combining superior sequencing with bioinformatics, creating a high degree of certainty of a genetic match to a reference molecule, and the automation of sample prep, reducing the rate of human error.
These systems represent a unique combination of hardware and advanced software that is not entirely new for the food safety industry, but certainly not the status quo today. Currently, it is common practice for the food safety industry to purchase hardware in the form of a PCR testing box or an antigen-based testing box that sits on a table in a lab. There may be some lightweight software included, but any big improvements or added features and functionality often come with an entirely new piece of hardware.
However, the food safety lab of the future deserves to benefit from the same practices as traditional enterprise software companies. Labs are going to experience updates and new features on a regular basis. Instead of new hardware every five to 10 years, new features and better systems are added far more regularly, on an ongoing basis.
NGS leaves room for incremental improvement over rip-and-replace, a quality that means labs can continue on the cutting edge without the expense of all new hardware.
When good enough stops being good enough
Accuracy is the end-all be-all in food safety, and we should always be striving for greater levels of accuracy and fewer errors. While many are hesitant to upgrade an entire system that has existed for decades, change is not the biggest risk. Settling for good enough is far riskier.
We are at a point in technology when tools like bioinformatics, hardware and software are tried, true and tested. While each individual component has value, the traditional model of “duct-taping” together these different pieces can lead to its own operational limitations and inefficiencies.
If you think it may be time for an upgrade, here are a few ways you can make sure you’re doing your diligence and feeling good about the change.
First, do your research – make sure claims from your solutions providers are tested and backed by independent organizations like The Association of Official Analytical Chemists. Ask for an evaluation to compare new technology to your existing platforms. Talk to the experts. Their job is to answer your questions, and the sharing of information is only good for all of us.
Some of these questions include: To achieve your food safety goals, how many methods and platforms will you need to utilize? How will the platform's accuracy and turnaround time impact the company financially? For example, could false positives lead to product destruction and reworking or increased inventory holding costs pending confirmation?
Finally, make the move. It’s a bold one, but one that will save lives, and keep your brand strong. Be a visionary, and make food safety a cornerstone of your company.
Good enough isn’t good enough when there exist superior solutions. Especially when it comes to something like the food system, that literally impacts millions and millions of people every day, it’s not just important to bring the most reliable and effective solution forward, it’s an imperative.