Last month, the Sample6 DETECT/L listeria environmental assay was certified by the AOAC. DETECT/L is the first in-shift non-enrichment test that the AOAC has ever certified. To our customers, this is a critical milestone, required for the adoption of a new diagnostic. Our advisor, David Acheson of The Acheson Group, describes it as “the gold standard in validation for food safety diagnostics and indicates a high standard of product that users can have confidence in.”
Over the past 2 years, I have frequently joined presentations, demonstrations and field visits on our first product, Sample6 DETECT/L. The audiences have ranged from microbiologists to plant workers, to plant managers to corporate vice presidents to investors. The conversation always follows a similar pattern. Everybody gets the “why” immediately: a Listeria assay that produces results in less than a single shift is better than diagnostics that takes 24 hours or more. Plant and production teams focus on the logistics opportunity to deliver safe products faster. Quality teams consider the opportunities to test closer to the product. Sanitation teams are excited by the ability to receive clear actionable information and microbiologists are excited to use this type of diagnostic to investigate presumed positives prior to sanitation. We hear unanimously that the opportunity to test and retest when conditions may still be representative will revolutionize testing, investigations and resolutions. But, no matter who I’m talking with, the next question is always the same, “How can you deliver results so quickly, how does it work?”
In order to develop a revolutionary diagnostic, we have processed thousands of real world samples using Detect/L. To measure our performance during development, we have confirmed each of these samples using traditional methods. Depending on our workload, sometimes we run confirmation in house and sometimes we ship them off to a third party lab. In the process, we’ve established great partnerships with labs around the country. We’ve also learned a lot about working with your outside lab.