This article has been updated from a previous version to reflect the updated name of the SARS-CoV-2 virus, which was previously named 2019-nCoV.
NEW YORK – Qiagen is developing a pair of molecular assays to detect SARS-CoV-2, the virus that causes COVID-19, 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 SARS-CoV-2.
The panel test will be called QiaStat-Dx Respiratory Panel [Plus], and will include two molecular targets specific to SARS-CoV-2: 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 SARS-CoV-2 — 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."
Simultaneously, through its facility in Shenzhen, China, Qiagen scientists are developing a single-plex RT-qPCR assay for SARS-CoV-2 that would be able to run on any real-time PCR system. Bernard said that Qiagen intends to submit this assay for use only in China.
By this point, dozens of companies and government or academic labs have developed or have begun developing molecular assays for SARS-CoV-2, and the FDA has issued emergency use authorization to the PCR assay developed by the US CDC (and is likely currently weighing EUA approval of other tests).
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 SARS-CoV-2.
"I think it's good that we have those two pathways in parallel," Bernard said. "I believe that it makes more sense to be able to differentiate all the potential respiratory syndromes, because the [SARS-CoV-2] latency period is … most of the experts are saying 10-14 days, during which many, many patients are asymptomatic. I believe that the syndromic approach is powerful, but it is good to have both."
Other entities are already considering the same approach as Qiagen is with its syndromic panel. Luminex CEO Nachum Shamir said during the company's earnings call this week that Luminex last week applied to China's National Medical Products Administration for approval and emergency use authorization of its NxTag Respiratory Pathogen Panel (RPP), which features multiple coronavirus targets but none specific to SARS-CoV-2, and can be used as a rule-out test. Luminex said it is also developing an unspecific multiplex test that features SARS-CoV-2 targets.
In addition, the Hong Kong Polytechnic University said on Tuesday that it has developed an automated multiplex diagnostic system for point-of-care molecular testing of respiratory pathogens including SARS-CoV-2. The system also uses qPCR technology that can identify 30 to 40 pathogens from a single sample in about an hour, including influenza A subtypes H1, H2 and H3; avian influenza viruses H5, H7 and H9; human respiratory syncytial virus; severe acute respiratory syndrome coronavirus (SARS-CoV); Middle East respiratory syndrome coronavirus (MERS-CoV); and SARS-CoV-2.
The group said that it has already used the system to conduct tests on clinical samples during China's SARS-CoV-2 outbreak, but did not provide additional details about its plans for regulatory approval or commercial distribution.
Meanwhile, perhaps the most well-known and earliest player in the syndromic infectious disease space, BioMérieux's BioFire Diagnostics, is laying low for the time being. The firm currently offers several FDA-cleared and CE marked syndromic panels on its FilmArray testing system, including a respiratory pathogen panel and pneumonia panel, neither of which contains targets for SARS-CoV-2. A company spokesperson said this week that it is too early for the firm to share its plans regarding the potential development of an updated version of its panels.