COVID-19 continues to be a global emergency. As nations and economies attempt to reopen, the rate of viral spread and deaths continues to rise, particularly in many large urban centers within the United States, where shelter in place orders did not sufficiently reduce infection burden. Continued improvement in SARS-CoV-2 testing infrastructure and test performance are urgently needed. False negative testing rates have been reported at 30-50%, meaning that for every 10 COVID-19 positive patients tested, 3 to 5 will receive an inaccurate negative result. These false negative rates occur with all testing platforms currently used, making control of viral spread nearly impossible. While the technology underlying the test systems themselves are technically very sensitive, much of the lost sensitivity arises earlier in the test process during sample collection, transportation, and RNA extraction. Global rates of high false negative test results ? using the best test kits and protocols ? continue to arise from two major sources: First, samples are not well preserved in CDC endorsed Viral Transport Media/Universal Transport Media (VTM/UTM) or other transport medias, leading to a 10-100x signal loss as a consequence of poor preservation; Second, the remaining sample is then further diluted often to 0.25% of the original concentration during extraction before going into the test. Until these fundamental testing problems are solved, and with no other solutions available, high false negative test results will allow viral spread to continue rising. In order to address this unmet need, Convergent Genomics has developed Enhanced Preservation Media?, a universal specimen transportation and integrated extraction solution, to significantly improve testing performance. Enhanced Preservation Media (EPM) enables the following testing improvements: EPM is built for seamless integration with point-of-care or centralized PCR tests world-wide; EPM will achieve FDA approval as the first integrated stabilization and extraction preservation media for SARS-CoV-2; and EPM will be clinically validated with leading research centers for expanded community surveillance testing of SARS-CoV-2. Our proprietary buffer protects free nucleic acids by multiple mechanisms, destroys virus to protect testing personnel, and facilitates simple, high-throughput extraction of entire samples. In vitro testing has demonstrated the capabilities of this platform to significantly improve testing performance in the most challenging low viral load samples.
This project supports the emergency repurposing, FDA submission, and clinical validation of Enhanced Preservation Media (EPM), a sample transportation, preservation, and extraction technology for SARS-CoV-2 testing. Early data supports a 10-100x improvement in SARS-CoV-2 testing sensitivity when nucleic acid tests are combined with EPM sample collection. EPM will be demonstrated universally compatible with both rapid point-of-care and centralized lab nucleic acid testing, and provides multiple advantages over currently available solutions.