PLEASANTON, Calif.--(BUSINESS WIRE)--GenTegra, LLC, a Pleasanton, California-based company, announced today a study on the development and characterization of two novel COVID-19 saliva sample collection tube devices. The publication is posted on medRxiv, the pre-print server for health sciences. https://www.medrxiv.org/content/10.1101/2021.01.20.20243782v1
The GenTegra GTR-STM™ and direct-into-PCR GenTegra GTR-STMdk™ saliva sample collection tubes are the only devices that eliminate dilution of virus levels in saliva samples, while providing a safe and convenient means to transport saliva samples at ambient conditions. The dried transport media formulation in both of these devices incorporates the company’s Active Chemical Protection™ (ACP) technology to provide substantial improvements in SARS-CoV-2 viral RNA stability, and RT-PCR process efficiency for COVID-19 saliva testing. Direct-into-PCR, GTR-STMdk eliminates the need for expensive and time consuming RNA extraction, improving the turnaround time for reporting test results. The two novel products are available to CLIA certified laboratories and IVD assay kit manufacturers pursuant to regulatory approvals in their respective US FDA Emergency User Authorization (EUA) protocols.
“By creating a dry transport media formulation of our proven ACP technology, we have eliminated many of the risks and error prone steps involved with current COVID-19 saliva collection products,” said GenTegra President Bob Barrett. “Most importantly, eliminating the addition of a liquid sample stabilizer may improve low copy number detection, and may address some of the concerns of potential false negatives due to sample dilution. This may be especially true when testing asymptomatic populations where viral load in saliva may be low and when multiple samples are pooled for greater testing efficiency,” added Barrett.
The company’s ACP technology incorporates a proprietary combination of small molecule inhibitors, antioxidants, metal chelators, and anti-microbials to provide total protection for SARS-CoV-2 virus and viral RNA at ambient temperatures. Proprietary ACP chemistry reduces saliva viscosity, inactivates contaminating RNases, and bacteria, and facilitates sterilization of samples at 95C making the sample safe for lab personnel and testing. ACP chemistry is guanidinium free making it compatible with lab automation and self-sterilizing PCR instrumentation.
GenTegra’s mission is to improve the quality of biological research and medical care by protecting sample integrity. GenTegra is committed to providing solutions for maintaining the pristine quality of biological specimens. The decisions made from the analysis of such specimens, whether it be viral samples from an emerging infectious disease, RNAseq samples shipped around the globe, or whole blood from patient-directed sampling devices, is only as good as the stability and quality of the sample.