NEW YORK, July 19, 2021 /PRNewswire/ -- Mirimus, Inc., a leader in conducting high-volume, high-quality PCR testing, today announced the publication of a peer-reviewed paper by EClinicalMedicine, an open access medical journal published by The Lancet. The paper, titled, "Implementation of a Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections in K-12 Schools and Universities," highlights the use of Mirimus' pioneering SalivaClear pooled saliva-based COVID-19 testing platform by schools and universities as an effective, fast and affordable means to implement a weekly COVID-19 surveillance testing program.
The SalivaClear platform provides an efficient and affordable alternative to individual PCR testing. The technology combines saliva-based sampling, pooled testing and gold-standard PCR molecular diagnostics to enable frequent, high-quality, high-throughput detection of SARS-CoV-2, the virus that causes COVID-19. SalivaClear combines, or pools saliva samples from up to 24 individuals and then analyzes the pools in a single test to save time and cut costs.
The study, authored by Prem Premsrirut, M.D., Ph.D., Co-founder and CEO of Mirimus, and researchers from institutions including SUNY Downstate Health Sciences University, Medstar Health Research Institute, Georgetown University, the Minnesota Timberwolves, and the SalivaDirect team at the Yale School of Public Health, looked at data from the testing of 253,406 saliva samples collected during a 20-week span from August 2020 to January 2021 from students, faculty and staff at 93 K-12 schools and 19 universities. The study showed that schools that performed regular surveillance testing with SalivaClear were able to quickly identify COVID-19 hotspots before they became outbreaks, providing critical, real-time information that allowed school officials to adjust safety protocols and minimize transmission among students and faculty. As a result, all schools utilizing the SalivaClear testing platform in this study, remained open to in-person learning.
In addition, the study established that SalivaClear provided a similar sensitivity to the molecular assay of individual samples, in terms of both qualitative and quantitative measures. The data also demonstrated that pooling saliva samples substantially reduced the cost associated with PCR testing.
"Now, more than ever, this data validates our long-standing belief that saliva-based pooled testing should be a fundamental component for all schools and universities when students return to class in the autumn," stated Dr. Premsrirut. "Since we compiled the data for this study, vaccines have been developed and millions have been immunized against the virus. Still, COVID-19 remains a pernicious disease around the world. Routine testing will be crucial to resuming normal life, in particular the safe return of students to school and university classrooms in the autumn and for return-to-work."
Mirimus collected 237,164 individual saliva samples from students, faculty and staff at 93 K-12 schools and obtained 16,242 saliva samples from students, faculty and staff at 19 universities and colleges. The samples were condensed into 11,473 pools and tested using SalivaClear. Schools received the test results within 18-30 hours of sample collection, on average.
A total of 855 positive individual samples were detected using the SalivaClear platform, for a 0.3% individual positivity rate. Importantly, Mirimus detected significant spikes in the number positive samples in the days following long weekends and holidays, which tracks with overall COVID-19 positivity trends. Specifically, the largest increase in the number of positive samples was observed five days after New Year's Eve (January 5, 2021; 39 positive pools, 115 positive individuals).
Dr. Premsrirut continued, "To be sure, many students and faculty will be vaccinated by the time school resumes in September, but there is cause for concern. COVID-19 restrictions are being lifted everywhere despite the lagging vaccination rates in some states, especially in Mississippi, Louisiana and Alabama. Also, the Delta variant of COVID-19 is starting to spread and cause a high number of symptomatic breakthrough cases. The positivity rates we measured in our study show that gathering in groups, such as holiday celebrations, significantly increases the transmission of COVID-19, and while in-school transmission of COVID-19 appears to be relatively low, students and faculty are just as susceptible to COVID-19 infection as any population group. If, as we fear, many people remain unvaccinated, schools must continue to be extremely vigilant with mitigation protocols, including regular testing, in order to minimize exposure."
The research also evaluated the cost of the initial pooled testing, which averaged $10 (range: $8-$12) per individual for all participating schools. Reflex testing, which included the overall pooled to individual test, averaged $12.50 (range: $10-$15) per person. This cost included all testing supplies, logistics, and personnel as well as diagnostic reporting, and allowed for over a dozen districts to participate in the study.
Dr. Premsrirut concluded, "In order to provide enough testing capacity to safely open schools and provide testing for at-risk communities, pooled concepts, such as SalivaClear, must be further evaluated and considered. Importantly, lower pricing and pooled approaches allow for a 'multiplier effect' that can provide significant economies of scale, potentially decreasing the costs even further at larger scale."
More information on this study is available at https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00308-4/fulltext.
SalivaClear, developed by Mirimus, Inc., is a pioneering COVID-19 testing platform that combines saliva-based sampling, pooled testing and PCR diagnostics to enable high-quality, high-throughput, low-cost detection of SARS-CoV-2. SalivaClear is designed to accomplish what other COVID-19 testing approaches have thus far been unable to achieve – providing a SARS-CoV-2 diagnostic system that can be easily and repeatedly utilized by myriad organizations, from schools to businesses to government organizations, to test (and retest) groups of individuals in order to quickly isolate COVID-19 hotspots before they can become outbreaks. For more information, please visit www.salivaclear.com.
About Mirimus, Inc.
Since its founding 10 years ago, Mirimus, Inc. has established itself as a leader in conducting high-volume, complex and highly effective PCR testing. This unique skillset led Mirimus to develop SalivaClear, a COVID-19 testing platform that combines saliva-based sampling, pooled testing and PCR diagnostics to improve the scalability, efficiency, cost-effectiveness and accuracy of COVID-19 testing. For more information, please visit www.mirimus.com and www.salivaclear.com.
SOURCE Mirimus, Inc.