SpeeDx Receives CE-IVD Mark for PlexPCR® SARS-CoV-2
26.4.2021 10:00:00 EEST | Business Wire | Press release
SpeeDx Pty. Ltd. announced today it has received CE-IVD marking for its Plex PCR ® SARS-CoV-2* assay – a two gene test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. The high-throughput test is compatible with 96- or 384-well qPCR systems and liquid handling robotics to support a streamlined laboratory workflow and accelerate time to result.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210426005269/en/
The PlexPCR® SARS-CoV-2 assay targets two highly conserved regions of the SARS-CoV-2 genome. Designed and tested against a database of over 1,000,000 sequences, the performance of the PlexPCR® SARS-CoV-2 assay can detect all known circulating variants. The high-throughput test is compatible with 96- or 384-well qPCR systems and liquid handling robotics to support a streamlined laboratory workflow and accelerate time to result. (Photo: Business Wire)
“The COVID-19 pandemic has impacted testing laboratories throughout the world as many diagnostic supply companies have struggled to meet testing needs,” said SpeeDx CEO Colin Denver. “This has disrupted supply chains and impacted efficiency across the board. SpeeDx has the advantage of not needing to manufacture target-specific, expensive, and time-consuming testing probes. 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.”
The Plex PCR® SARS-CoV-2 assay targets two highly conserved regions of the SARS-CoV-2 genome (RdRp and ORF1ab). Designed and tested against a database of over 1,000,000 sequences, the performance of the Plex PCR® SARS-CoV-2 assay can detect all known circulating variants§. Regular computer-based analysis is performed to ensure new, emerging variants of the SARS-CoV-2 virus can be effectively detected, without the need for confirmatory testing.
The Plex PCR® SARS-CoV-2 assay has compatible workflow with the Plex PCR® RespiVirus† test, a two-well multiplex assay for the detection of 14 targets from 11 viral respiratory-illness causing pathogens including Influenza A, Influenza B, and Respiratory Syncytial Viruses (A & B). Both respiratory tests are also compatible with the SpeeDx Plex Prep™ - a compact and cost-effective liquid handling system. The combination of Plex Prep™ robotics and automated software analysis can support a scalable workflow for throughputs of 480 to 1,920 patient samples in an 8-hour shift. A respiratory bacteria test is due for launch later this year to complete SpeeDx’s respiratory infectious disease test portfolio.
The addition of Plex PCR® SARS-CoV-2 broadens SpeeDx’s available testing menu from the current suite of tests for sexually transmitted infections and antimicrobial resistance markers that include Resistance Plus ® MG† and Resistance Plus ® GC† – supporting Resistance Guided Therapy for Mycoplasma genitalium and gonorrhoea respectively – and Plex PCR® VHS†, a multiplex lesion diagnostic test.
*not available in the U.S. or Australia
§based on in silico investigation as of April 2021
†not available in the U.S.
About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. SpeeDx has a portfolio of CE-IVD kits for detection of infectious disease pathogens, sexually transmitted infection (STI), and antimicrobial resistance markers. SpeeDx ResistancePlus tests enable Resistance Guided Therapy, improving patient outcomes by empowering practitioners to make informed clinical decisions.
For more information about SpeeDx please see: http://plexpcr.com
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210426005269/en/
Contact information
Global Marketing Director
Madeline O’Donoghue
madelineo@speedx.com.au
+61 406 582 808
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Midas Atlantic Partners, in Partnership With the Najafi Companies, Has Entered Into a Put Option Agreement With Sylvamo Relating to the Potential Acquisition of Its European Operations6.11.2026 13:04:00 EET | Press release
Midas Atlantic Partners (“Midas Atlantic”), in partnership with The Najafi Companies, has signed a put option agreement with Sylvamo Corporation (“Sylvamo”) relating to the potential acquisition of its European operations (the “Business”). The transaction comprises Sylvamo’s uncoated freesheet paper mills in Saillat and Nymölla, as well as its forestry and supporting business operations across Europe. Closing is expected in the first quarter of 2027, once the required consultation processes are completed and regulatory approvals are obtained. The Business is a leading European producer of uncoated woodfree (UWF) paper for office and commercial printing. Its product portfolio spans cut-size office paper, sold under its own brands such as REY and Multicopy as well as on behalf of major OEM and office supplies customers, and paper reels for commercial printers and converters. Headquartered in Belgium, with two large-scale, vertically integrated pulp and paper mills, it serves a longstandi
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 01:23:00 EET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
iQmetrix Unveils Built-In Intelligence for Every Role in Telecom Commerce at Its 2026 Telecom Industry Address5.11.2026 23:39:00 EET | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, last week shared highlights from its 2026 Telecom Industry Address and Product Announcements, held virtually on Oct. 28 in two sessions, one for North American audiences and one for European audiences. The address was built around one theme: intelligence. Telecom commerce is moving from systems that record the business to systems that act on it, and the announcements put that intelligence in the hands of every role, from the sales associate at the counter, to the finance manager in the back office, to the corporate view leading the channel experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261105003162/en/ "Right now telecom providers are competing in a race to the bottom on price that no one wins. The way out is intelligence. Not AI bolted onto a fragmented tech stack, but intelligence built into how commerce runs. Information plus
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.11.2026 23:30:00 EET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to nine newly hired non-executive employees. The equity awards were granted on November 2, 2026, and consisted of options to purchase an aggregate of 59,275 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 28,200 shares. These options have an exercise price per share equal to $8.41, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted s
Graco QUANTM i230 Brings Electrification to High-Flow Fluid-Transfer Applications5.11.2026 23:16:00 EET | Press release
Graco Inc. is helping manufacturers electrify high-flow fluid-transfer applications with the global launch of the 3-inch QUANTM® i230, bringing efficient electric drive technology to demanding processes that have traditionally relied on pneumatic pumps. Paint, coatings and ceramics manufacturers depend on diaphragm pumps for their flexibility, reliability and ability to handle challenging materials. But pneumatic pumps also depend on compressed air — an energy-intensive plant resource whose available capacity can fluctuate as demand changes across a facility. The QUANTM i230 gives manufacturers another option for qualified high-flow applications. By combining familiar diaphragm pump capabilities with electric operation, the pump helps manufacturers move more material, reduce transfer bottlenecks and lower energy consumption by up to 80% compared to pneumatic pumps, while maintaining operating flexibility. “High-flow processes in industries like paint, coatings and ceramics have continu
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom