Cannabis Industry Can Now Avoid Costly Recalls with Groundbreaking Scientific Approval

01 June, 2021

bioMérieux, Inc. Awarded First-ever Cannabis-related AOAC Emergency Response Validation for the Enumeration of Yeast & Mold Contamination for its TEMPO® YM Assay

Chicago, Illinois June 1, 2021 — bioMérieux, a world leader in the field of in-vitro diagnostics, today announced that it has received the first-ever cannabis-related Performance Tested MethodsSM (PTM) validation for the enumeration of yeasts and molds for its TEMPO® YM Assay (PTM 041001) by the AOAC INTERNATIONAL’s Emergency Response Validation (ERV) program. This validation represents the first of its kind for the cannabis industry, providing AOAC approved enumeration in cannabis flower for 10g samples.

State regulations and recent cannabis related recalls related to yeast and mold contamination identified an emergent need for the cannabis industry to have access to validated microbiological methods for the reliable and accurate enumeration of the potentially dangerous contaminants. Yeast and mold contamination can affect cannabis consumer health and can be an indicator of manufacturing and product quality. Out-of-compliance product can trigger costly recalls. “With known issues of yeast and mold contamination and recent outbreaks in the cannabis industry,” states John Mills, Senior Scientist of Scientific Affairs at bioMérieux, Inc., “the need for reliable, automated, and validated microbiological methods is critical for the industry and consumers.”

The AOAC ERV brings safety and quality to the cannabis industry as a result of the validation guidance developed through the Cannabis Analytical Science Program microbial contaminates working group. The AOAC Research Institute ERV program provides independent third-party expert review and certification for proprietary test method performance, and the PTM certification mark assures users that an independent assessment found that test method performance meets the appropriate standard for its intended use. “The AOAC ERV for yeast and mold enumeration provides a pathway for rigorous independent third-party validation of test kits in cannabis flower in a shorter, more responsive, time frame,” continues Mills.

“The TEMPO YM assay holds worldwide approvals and bioMérieux is excited to now include cannabis flower in that scope” states Mills. The TEMPO YM ERV cannabis validation joins the bioMérieux suite of GENE-UP AOAC PTM approved methods for detection of Aspergillus, Salmonella and Shiga toxin-producing E. coli (STEC) in cannabis.

Now, growers and manufacturers along with their laboratory partners can confidently test cannabis flower with TEMPO YM in meeting compliance requirements of state regulations. Combined with the AOAC approval, TEMPO brings quality, standardization, and traceability to the microbiological testing operation. TEMPO YM is an automated enumeration method, meeting the regulation requirements in several states.

The TEMPO YM approval demonstrates bioMérieux’s true commitment to consumer’s safety and public health by improving product safety and meeting the scientific needs in emerging industries. The approval adds to bioMérieux’s already vast AOAC approved portfolio across their pathogen and quality indicator suite of solutions, and demonstrates a long-standing commitment to robust, sound, and validated science. The new AOAC approval brings safety and quality to the cannabis industry. The AOAC is a global standardization organization that validates analytical test methods. The AOAC Performance Tested MethodsSM designation is recognized by the US Department of Agriculture, the Food and Drug Administration, and global regulatory agencies. Visit AOAC’s website to learn more about their validation process and explore our website to learn more about our suite of food safety and quality solutions.


About bioMérieux

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2020, revenues reached €3.1 billion, with over 93% of sales outside of France.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

 

Contacts

bioMérieux Inc.:
Joy Dell'Aringa
224-213-1756
joy.dellaringa@biomerieux.com

bioMérieux Corporate Industry Head Office:
Olivia Seward
+33 (0) 668740207
olivia.seward@biomerieux.com

Pioneering Diagnostics