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QuantumDx Gets CE Mark for Rapid Point-of-Care PCR System

NEW YORK – QuantumDx announced Friday that it has obtained CE-IVD marking for its rapid PCR, point-of-care diagnostic system along with an assay to detect SARS-CoV-2 virus.

The Newcastle upon Tyne, UK-based firm plans to launch the system at the European Congress of Clinical Microbiology and Infectious Diseases conference, which begins online Friday.

The Q-POC system is a fully integrated, sample-to-answer, portable qPCR instrument that yields results in approximately 30 minutes. It uses lyophilized onboard reagents that can be stored at room temperature.

The system uses assay cartridges and performs extraction and enrichment followed by six-channel real-time PCR. It can run multiplex assays, and it connects wirelessly to lab information systems.

The SARS-CoV-2 assay — which is contained in a sealed, single-use test cassette — showed a 96.9 percent sensitivity and 98.3 percent specificity in an evaluation at St George's, University of London, QuantumDx said in a statement.

Q-POC has been designed for front-line healthcare professionals and can be used within a wide range of settings, including emergency rooms, ICUs, birthing centers, clinics, and pharmacies, QuantumDx also said.

"Q-POC represents a new class of molecular diagnostic device: It's fast, battery operated, can multiplex, and is so simple to operate that anyone can be trained to use it," said Jonathan O'Halloran, chief executive of QuantumDx.

The firm expects to expand the menu of Q-POC assays over the next few years to include large syndromic panels and antimicrobial resistance mutation panels.

QuantumDx raised £11 million ($15.1 million) in March to support manufacturing and commercial scale-up of its Q-POC. It had previously raised £16 million in UK government funding to accelerate the development and scale-up of the system in response to the COVID-19 pandemic, as well as £10 million in convertible loan notes.

The firm was also awarded up to $3.7 million along with collaborator SpeeDx by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, to develop a rapid point-of-care test to diagnose Chlamydia trachomatis and Neisseria gonorrhoeae infections, as well as to determine the antibiotic susceptibility of gonorrhea infections.