EF-001 Environmental Screening - Food - AOAC PTM

EF-001 Environmental Screening - Food - AOAC PTM, (EF-001)

Provide testing for Listeria SPP, Salmonella SPP and L.Mono for an AOAC PTM approved solution on surfaces, specifically stainless steel, plastic and rubber.

This will include the VIABLE Protocol. Each kit is capable of running 96 samples.

EnviroX is a screening and monitoring diagnostic tool. The array contains probe sequences designed to detect a wide range of organisms known to be environmental contaminants or pathogens. The exclusion of a sample enrichment requirement ensures an accurate representation of the tested microbial population by avoiding sample enrichment bias. This assay is best applied as a monitoring, research, or screening tool. Possible uses may include investigating sources of contamination, testing the effectiveness of remediation methods, or screening potential facilities for pre-existing contamination.

With its proprietary technologies, PathogenDx designs and develops nucleic acid test kits and automation for the detection and speciation of a few, up to several dozen microbial or viral pathogens as a single test panel. The kits and associated imager (SensospotTM) are sold to regulated testing labs in Cannabis, Food, IVD and Environmental Screening markets. Although the pathogen test content varies based on the market application, the technology has as its core a type of low cost DNA microarray, mass produced as a 96 well SBS-formatted microplate, delivering up to 400 oligonucleotide hybridization tests in parallel, per well.  In each kit, the microarray plate is provided with all reagents needed for automated or manual sample preparation (96 samples) then multiplex asymmetric PCR or RT-PCR (96 samples) which then  generates amplicon products which are then analyzed (up to 96 samples in parallel) on a single SBS-Format plate. Subsequent to room temperature hybridization and washing, by hand or with an ordinary off-the-shelf fluid handling robot, the resulting microarray test is imaged on a dedicated 96 well plate imager (SensospotTM). All 96 array images are then analyzed via simplified, hands-free, autonomous software (AuguryTM) that is provided as a no-cost license with the kits. The software is configured to run locally, or as part of a cloud-based testing system, which is accessed over the internet on a secure Portal. The Portal, also provided as a no-cost license, enables secure data storage and sharing and technical support from PathogenDx staff.