The Straight Line to Microbial Testing Applications
TessArae’s exclusive technological advantage empowers the simultaneous detection and identification of dozens of different virus types and bacterial species–all in a single sample, with a single test, in less than 24 hours.
Uniquely Precise Unlike PCR-based assays, the TessArae solution can detect and characterize genomic variants of targeted pathogens down to the nucleotide level. Novel and emerging pathogens arising from genetic drift and shift are readily identified, and closely related strains are clearly differentiated.
Uniquely Powerful This enables a range of powerful applications; TessArae technology is the ideal solution for:
- detection of emerging strains during infectious disease outbreaks
- tracking the spread of foodborne pathogens through populations or back to the source
- detection of viral and bacterial contaminants in pharmaceuticals and production areas
Uniquely Complete The generation of genomic sequence information with automated data analysis makes TessArae assays a truly complete solution to your microbial detection and identification needs.
Adventitious Viral/Bacterial Contamination
Adventitious Viral Contamination
Biopharmaceutical drugs and some vaccines are manufactured in costly mammalian cell cultures. These environments are uniquely vulnerable to adventitious contamination by viruses or bacteria. Such contamination can increase manufacturing costs, reduce product yields, and prompt FDA inspections. This can result in significant losses for manufacturers and critical shortages of drug for patients. The Circovirus contamination in the manufacture of Rotarix® vaccine is an example.
TessArae is partnering with premier global biopharmaceutical manufacturers to develop an assay that provides sensitive detection of a broad range of mammalian viruses. The TessArae solution will mitigate the risk of adventitious contamination by simultaneously detecting unknown or novel virus subtypes, a major limitation of PCR.
Bacterial contamination
Small molecule pharmaceuticals (oral drugs) may become contaminated with bacteria and fungi in the environment of manufacturing work areas, production machinery, or raw materials. Microbial contamination increases manufacturing costs by delaying lot releases or increasing product loss if the contaminant is identified as an objectionable organism.
TessArae technology can definitively identify all objectionable organisms present in a positive mixed culture, eliminating the need for a pure culture, Gram stain, or PCR. This dramatically reduces time-to-result for faster lot release. In addition, TessArae assays can differentiate between highly related species of the same genus, minimizing product loss and QC costs when a closely related organism is erroneously identified as objectionable.
TessArae has developed assays for the detection and definitive identification of dozens of viral and bacterial pathogens. Applications include:
RPM-Flu Simultaneous detection and identification of over 35 different bacterial genera and virus types of upper respiratory pathogens, providing genus-, species, serotype- and strain-level information with comprehensive coverage of influenza, including avian influenza.
This product was developed in collaboration with the US Naval Research Lab
RPM-TEI Comprehensive detection of over 40 different bacterial genera and virus types of tropical and emerging pathogens, including CDC Category A, B, and C threat agents and closely related confounding organisms.
This product was developed in collaboration with the US Naval Research Lab and USAMRIID
RPM-HFV Complete genome sequencing of numerous hemorrhagic fever viruses to strain level for identification of known and unknown isolates.
This array was developed in collaboration with USAMRIID
RPM-FS Simultaneous detection and identification of over 25 different bacterial genera and virus types of foodborne pathogens. This assay was developed under a Phase I SBIR grant from the USDA.
In collaboration with the FDA Center for Food Safety and Applied Nutrition, TessArae is developing a new assay for high-resolution differentiation of E. coli strains to monitor the spread of foodborne illness. This effort is funded by an SBIR Phase II grant from the USDA.
See Who is Using TessArae Microbial Identification Technology.