Fully automated, scalable Rheonix method shows robust detection of variants
ITHACA, N.Y. — Rheonix Inc. today announced that the Rheonix COVID-19™ MDx Assay will detect the newly emerging omicron variant of SARS-CoV-2, as well as other variants of public health concern. The company’s assessments indicate that its COVID-19 MDx Assay detects all SARS-CoV-2 variants of concern and variants being monitored by the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC).
The new B.1.1.529 variant of SARS-CoV-2, designated omicron by WHO, was first reported by South Africa on Nov. 24, 2021. Initial reports indicate it may spread more easily than other variants, and WHO has warned that it poses a very high global risk. Omicron has a large number of mutations across its viral genome; therefore, as with other strains of concern, analyses of commercial diagnostic assays must be performed to determine whether this novel strain will continue to be detected as reliably as the strains that were circulating when the assays were developed and validated.
“Rheonix continually assesses the potential impact of variants on assay performance by conducting ‘in silico’ analysis of publicly available SARS-CoV-2 sequence data as well as laboratory testing of prevalent variants,” said Gwendolyn Spizz, Ph.D., chief scientist at Rheonix. “The robust design of the Rheonix COVID-19 MDx Assay has allowed for the detection of all designated variants of concern to date, including the delta variant. Based on our analysis, we are highly confident in our ability to detect the omicron variant, and we will continue to rigorously monitor the public genome databases.”
The Rheonix COVID-19 MDx Assay was first granted emergency use authorization (EUA) status in April 2020. In a side-by-side comparison conducted by the U.S. Food and Drug Administration (FDA), the Rheonix assay was among the most sensitive methods.
Since early in the pandemic, Rheonix has been instrumental in enabling local and regional hospitals to bring COVID-19 testing in-house, reducing turnaround time from two weeks to same-day. The fully automated Rheonix Encompass MDx® workstation requires minimal technician time to operate, alleviating the demands on laboratory staff, and can be rapidly installed on a laboratory benchtop and ready to operate with minimal training. The Rheonix system’s high scalability and low cost enables laboratories to respond quickly to surges in testing demand. Expansion of the EUA in December 2020 to include saliva as a sample type has provided an option that is less invasive for patients, safer for medical personnel and more cost-effective for laboratories.
“Throughout the pandemic, Rheonix has partnered with customers to rapidly deploy workstations, reagents and on-site customer service,” said Greg Galvin, Ph.D., founder and CEO of Rheonix. “We recognize the impact of global reagent shortages and supply chain disruptions, particularly for regional hospital labs and underserved communities, and we remain committed to supplying reagents and consumables to meet 100% of our customers’ testing needs. To support this commitment, Rheonix has dramatically expanded our manufacturing capability to ensure ongoing availability of workstations and test kits.”
About Emergency Use Authorization Status:
The Rheonix COVID-19 MDx Assay is an endpoint RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory and saliva samples from individuals who are suspected of COVID-19 by their healthcare provider. The Rheonix COVID-19 MDx Assay has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Rheonix has developed the suite of Encompass workstations, fully automated systems that provide highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories. With minimal hands-on time, the Encompass systems offer true walkaway simplicity. Rheonix’s growing portfolio offers multiplexed testing solutions including the Beer SpoilerAlert19™ Assay, the most comprehensive beer spoilage panel available; the Listeria PatternAlert19™ Assay, a rapid method for Listeria strain typing; and the NGS OnePrep19™ solution, a fully integrated and automated DNA extraction and library prep solution. The Rheonix STI TriPlex19™ Assay and Rheonix Encompass MDx workstation are currently undergoing FDA 510(k) review. For more information, visit www.rheonix.com.