NGS assay intended for profiling SARS-CoV-2 genomic and subgenomic RNA in clinical specimens has compelling use cases for rapid public health response, research, and vaccine development
SINGAPORE, October 6, 2020 — Molecular diagnostics company Lucence today announced the availability of the world’s first assay kit to directly profile SARS-CoV-2 subgenomic RNA (sgRNA), a marker of active viral replication1, from clinical samples. DeepMARK™ utilizes Lucence’s proprietary ultrasensitive next-generation sequencing (NGS) technology, AmpliMARK™, to concurrently detect and analyze the genome and transcriptome of SARS-CoV-2.
Pinpointing sources of unlinked SARS-CoV-2 cases via DeepMARK™ profiling can support rapid public health response. Using high-quality genetic fingerprinting, DeepMARK™ can enable rapid community case tracing by precisely identifying transmission paths, clusters, and viral contagiousness. DeepMARK™’s increased sensitivity also allows for asymptomatic and recovering cases to be more thoroughly evaluated for contagiousness.
For researchers studying contagiousness, SARS-CoV-2 sgRNA is a recognized marker of active viral replication linked with contagiousness2 and offers several advantages. While viral culture is the gold standard, it is slow, expensive, and requires a biosafety level 3 (BSL3) laboratory, requirements prohibitive for the vast majority of samples. Using DeepMARK™, clinical samples can be safely and efficiently profiled using a simple workflow.
SgRNA as a marker of viral replication is also a well-recognized efficacy measurement in SARS-CoV-2 vaccine development3. Thus, comprehensive sgRNA profiling by DeepMARK™ could facilitate more efficient vaccine discovery.
“Genetic fingerprinting enables quicker and deeper analysis of viral spread. This tool has enhanced our capacity to understand SARS-CoV-2 precisely and contributes to the ongoing fight against COVID-19.” said A/Prof Hsu Li Yang, Vice Dean, Global Health, Saw Swee Hock School of Public Health, National University of Singapore.
DeepMARK™ is part of Lucence’s suite of SARS-CoV-2 molecular diagnostics. Lucence also makes the SAFER™ Sample Kit, a saliva stabilization kit with reported 36% higher sensitivity for detecting COVID-19 compared to nasopharyngeal swabbing4.
DeepMARK™ is a next-generation sequencing (NGS) assay kit for the qualitative analysis of SARS-CoV-2 RNA. For Investigational Use Only. The performance characteristics of this product have not been established.
- Roman Wölfel, et. al. (2020, April 1) Virological assessment of hospitalized patients with COVID-2019
- Ranawaka A.P.M. Perera, et. Al. (Vol. 26, No. 11 – Nov 2020) SARS-CoV-2 Virus Culture and Subgenomic RNA for Respiratory Specimens from Patients with Mild Coronavirus Disease
- Kizzmekia S. Corbett, Ph.D., et. al. (2020, July 28) Evaluation of the mRNA-1273 Vaccine against SARS-CoV- 2 in Nonhuman Primates
- Alvin Teo KJ, Choudhury Y, et. al. (2020, Aug 13). Validation of Saliva and Self-Administered Nasal Swabs for COVID-19 Testing