GenTegra, LLC Announces New SARS-CoV-2 Sample Stabilization and Transport Products to Facilitate Expansion of COVID-19 Testing
Unique Dried Saliva Transport Media Provides Simple and Safe Collection Without Sample Dilution
Pleasanton, Calif. – June 16, 2020 – GenTegra, LLC today announced early access availability of two new viral stabilization products. GenTegra® GTR-STM™ and GenTegra® GTR-VTM™ have been developed to address sample transport and stability challenges associated with SARS-CoV-2 specimens and to facilitate broader COVID-19 testing strategies. Both products have been formulated to protect viruses and RNA at ambient temperatures for extended periods, eliminating the cost of cold chain and the risk of sample loss due to degradation. The new GenTegra sample stabilization products are being made available under an Early Access Program to CLIA-certified laboratories performing authorized molecular diagnostic assays for SARS-CoV-2.
Specimen stability and protection methods are becoming increasingly important as sample collection becomes more decentralized and as testing volumes increase to accommodate back-to-work and remote sample collection and testing programs. SARS-CoV-2, the cause of COVID-19 disease is an RNA virus, and it is the viral RNA that is detected by current molecular diagnostic assays. However, RNA is extremely unstable and is highly susceptible to degradation immediately upon collection. According to CDC guidelines, COVID-19 samples collected in current viral transport products must be stored at 2-8°C (refrigerated) upon collection, and frozen at -70°C if testing is delayed beyond 72 hours. This adds significant logistics and material costs to collection and testing of clinical specimens. If the RNA in the specimen is not protected from degradation, the subsequent molecular diagnostic assay may be more likely to produce an erroneous result, a problematic event in trying to control the current pandemic.
GenTegra GTR-STM is a unique viral transport media designed specifically to stabilize viruses and RNA in saliva samples for over 40 days at ambient temperatures. “Saliva will likely become the sample of choice as COVID-19 testing expands. Saliva is a safe, comfortable, and easy specimen to collect in all settings,” said Shanavaz Nasarabadi, chief executive officer at GenTegra. “What makes GenTegra GTR-STM unique is that it is a dry stabilization formulation that will not dilute the sample, thereby minimizing potential test sensitivity issues. The GTR-STM product inactivates the virus, and does not contain guanidine thiocyanate, making it safe to use with automated testing systems that utilize bleach for cleaning and sterilization.
GenTegra GTR-VTM is a next generation viral transport media designed for stabilizing viruses and RNA from swab samples. GenTegra GTR-VTM has been formulated to protect viruses and RNA for over 40 days at ambient temperatures. Additionally, the volume of GTR-VTM required to stabilize the sample is much less than current methods, thereby reducing the impact of dilution on test results.
“The proprietary formulation of both GenTegra viral stabilization products utilizes chemical constituents that are completely unique compared to other products, thereby relieving pandemic-related pressure on the supply of commonly used chemical components,” added Nasarabadi.
About GenTegra LLC
GenTegra LLC has redefined ambient temperature stabilization of nucleic acids, proteins, phage and other biomolecules through proprietary Active Chemical Protection™ that protects and preserves them in a chemical matrix. GenTegra’s Active Chemical Protection is available in several forms including individual tubes, bulk material and on Ahlstrom-Munksjö paper products trademarked as GenSaver™ cards.
More information may be found at gentegra.com.