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SpeeDx Obtains CE-IVD Mark for SARS-CoV-2 PCR Test

NEW YORK – Australian diagnostics developer SpeeDx announced on Monday that it has obtained a CE-IVD mark for a real-time RT-PCR test to detect SARS-CoV-2.

The PlexPCR SARS-CoV-2 test detects conserved regions of the RdRp and ORF1ab genes of the virus using the firm's probe-free PlexPCR chemistry. The assay is compatible with 96- or 384-well qPCR systems and liquid handling robotics.

"Our unique technology has allowed us to bulk produce and stockpile universal raw materials, so we are able to rapidly fulfill all our current customers' orders while having the capacity to supply many more large-volume testing laboratories," said SpeeDx CEO Colin Denver in a statement.

The PlexPCR SARS-CoV-2 assay also has a compatible workflow with the firm's two-well multiplex assay for the detection of 14 targets from 11 viral respiratory-illness causing pathogens, called PlexPCR RespiVirus test.

Both respiratory tests are also compatible with the SpeeDx PlexPrep liquid handling system, SpeeDx said, noting that the combination of PlexPrep robotics and automated software analysis supports a scalable workflow for throughput of up to 1,920 patient samples in an eight-hour shift.

SpeeDx expects to launch a respiratory bacteria test later this year to complete its respiratory infectious disease test portfolio and is developing a respiratory virus-host response assay. In addition, the firm markets assays for sexually transmitted infections and antimicrobial resistance markers and is co-developing tests with Roche and Laboratory Corporation of America.

Separately, SpeeDx also announced on Monday that it will collaborate with Mississauga, Ontario-based Microbix Biosystems. Microbix will be the exclusive developer of quality assessment products to facilitate the registration and commercialization of SpeeDx diagnostic assays, beginning with SpeeDx's assay for antimicrobial-resistant strains of Mycoplasma genitalium. Producing controls for resistant M. genitalium in large enough quantities has posed technical hurdles, SpeeDx said in a statement, but these have been solved using proprietary Microbix technology.