PRINCETON, N.J. (PRWEB) August 01, 2020
ROSA Scientific, an on-demand diagnostic development start-up announced today the validation results of a Pooled Testing strategy for the detection of COVID-19 in saliva. In low-prevalence communities, Pooled Testing offers a 90% reduction in testing cost per patient by pooling samples. This is accomplished by taking “gold standard” RT-PCR testing technology, which detects the active presence of SARS-CoV-2, and adapting the lab protocol to allow samples to be pooled together. This allows a group of people who all test negative for coronavirus to be ruled out with very high confidence in a single test. An iterative algorithm is used to then efficiently re-group positive samples, resulting in fewer reagents being used, and ultimately significantly lower cost.
The test is co-developed with ZFRM, a leading research foundation based out of San Francisco, CA.
ROSA Scientific will seek Emergency Use Authorization for the COVID-19 test, under the U.S. Food and Drug Administration (FDA) regulatory pathway.
Of particular interest is a financially feasible solution that enables deployment into at-risk environments, like nursing homes, skilled nursing facilities (SNF), post-acute care centers, and clinics.
The test is also expected to be available in the Fall of 2020 for employers, in commercial, construction, restaurant, and general office environments.
The FDA together with numerous researchers have suggested that if pooled strategies are adopted in conjunction with exposure testing (e.g. antibody tests), communities would be able to rapidly prevent localized outbreaks from widely spreading in the community.
“There is critical need for at-risk communities like assisted living and high-contact essential-services, such as schools or meat packing facilities, to establish community-confidence that their patients or workers are infection-free. To do so requires routine and periodic testing of the entire population of workers or patients, which is restricted by cost and availability,” said Sarthak Sawarkar, CEO of ROSA Scientific. “By reducing the per worker or per patient cost of lab-based testing, Pooled Testing can fill an essential gap in community testing and help us return to normal faster.”
The test will not be directly available to the general public.
The test is being developed at ZFRM in San Francisco, California.
Results
“Our validation studies show that the pooling techniques are capable of consistently detecting one positive sample with RNA quantities as low as 100 copies/ul in a pool of 60 samples,” says Dr. Manuel Viotti, Senior Scientist at ZFRM. “We are the first research group to create an adaptable pooling strategy program for use in any laboratory. We foresaw that the virulence of SARS-Cov2 would outpace testing capabilities. So while authorities suggested a pooling strategy on the 1st of July, we have been working since April on pooling methods to optimally and reliably utilize in the field.” The protocol and software service will be available for license for a nominal charge for any laboratory that wants to utilize this technique.
About the Zouves Foundation For Reproductive Medicine
ZFRM aims to expand the understanding of human developmental biology by exploring and developing innovative research and technology, with a focus on molecular methods.
About ROSA Scientific
Founded in 2019, ROSA’s mission is to improve human health by better understanding complex diseases. For more information, please visit our website at rosascientific.com.