Genomic medicine startup Lucence and the Agency for Science, Technology and Research (A*STAR), Singapore’s national research agency and a statutory board under the Ministry of Trade and Industry, today announced study results indicating that the reagent used in Lucence’s SAFER Sample saliva collection kit inactivates SARS-CoV-2 within 45 seconds of sample collection.
The development of the SAFER Sample saliva collection kit was first announced in March this year, MobiHealthNews reported. The proprietary reagent also stabilizes viral RNA at room temperature for up to one week. The SAFER Sample Collection Kit is registered as a Class A medical device with the Health Sciences Authority of Singapore and is an easy-to-use saliva collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week.
Lucence worked with the Diagnostics Development (DxD) Hub of A*STAR to evaluate the virucidal (having the capacity to or tending to destroy or inactivate viruses virucidal agents virucidal activity) properties of the SAFER Sample reagent. Duke-NUS Medical School was also engaged to perform the virucidal work with SARS-CoV-2 virus.
WHY IT MATTERS
In this new study, Lucence and A*STAR demonstrated that the proprietary reagent provided with the SAFER Sample kit also achieved complete inactivation of SARS-CoV-2 virus within 45 seconds of exposure.
Conventional viral transport media used for collecting nasal and nasopharyngeal swab specimens do not inactivate viral samples, creating risk of exposure to active virus during transportation from collection sites to the laboratory and higher costs associated with biohazard handling procedures. SAFER Sample kit’s viral inactivation capabilities could mean enhanced safety and reduced risk of exposure for any individual involved in the collection, transport, and testing processes.
UPCOMING DEVELOPMENTS
Studies with clinical partners are ongoing to further evaluate the performance of the SAFER Sample kit. With the support of DxD Hub in verification and validation, quality management system (QMS), and regulatory registration, Lucence has received ISO13485:2016 certification for its QMS which controls the processes for the manufacture of the SAFER Sample Saliva Specimen Collection Kit.
THE LARGER TREND
Last month, Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore received a grant from the National Medical Research Council (NMRC) COVID-19 Research fund for the acceleration of R & D of rapid paper-based serological and diagnostic tests for COVID-19.