Qiagen is developing a pair of molecular assays to detect the 2019 novel coronavirus (2019-nCoV) from nasal swabs of symptomatic patients, a company executive said this week.
The first test, Qiagen’s priority, is an expanded version of the company’s US Food and Drug Administration-approved and CE-marked QiaStat-Dx Respiratory Panel, according to Thierry Bernard, Qiagen’s interim CEO, senior VP, and head of molecular diagnostics. Bernard said that Qiagen expects this test to be ready in February for review by various regulatory agencies as an emergency-use assay.
The second assay is a more standard quantitative RT-PCR assay for direct detection of only 2019-nCoV.
The panel test will be called QiaStat-Dx Respiratory Panel [Plus], and will include two molecular targets specific to 2019-nCoV: the ORF1b gene recommended by the Chinese Center for Disease Control and Prevention, and the N gene recommended by the US Centers for Disease Control and Prevention.
These targets will join the 21 other molecular targets on the current QiaStat-Dx Respiratory Panel, allowing for a syndromic approach to testing for 2019-nCoV — that is, healthcare workers will be able to simultaneously test symptomatic patients for multiple common viral and bacterial respiratory pathogens, including but not limited to four other coronaviruses, influenza A (and several subtypes), influenza B, Bordetella pertussis, Mycoplasma pneumoniae, and several parainfluenza viruses (though there are slight differences between the FDA-cleared and CE marked versions of the existing QiaStat-Dx panel, Bernard said).
The panel will run on the QiaStat-Dx syndromic testing system, which can detect as many as 48 targets simultaneously using multiplexed real-time PCR enabled by a proprietary microfluidic test cassette design and a six-wavelength optical sensor. The system also has FDA clearance and CE marking.
Bernard said that Qiagen has encouraging analytical validity data in hand from in-house testing, but declined to provide additional details at this time. He also said that the company has shipped approximately 200 new cartridges to its Hong Kong branch, which has in turn distributed them to four undisclosed laboratories in China for real-world evaluation against traditional single-plex PCR.
“Once this is validated, and we expect that well before the end of February, the cartridge will be made available as an emergency-use version, pending approval by relevant regulatory authorities,” Bernard said. “We will be looking at what we call a special notification in Germany; and [emergency use approval] in the EU; the [US] FDA; China; and with [Public Health England] in the UK.”
Qiagen’s updated respiratory panel, though, could be the first available assay to use a syndromic approach, the value of which lies primarily in being able to rule out infection with many other common pathogens that cause symptoms similar to 2019-nCoV.
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