Qiagen NV has started U.S. commercialization of a portable SARS-CoV-2 antigen testing device that can analyze up to 30 patient samples an hour.
The Qiareach test features a portable hub device – smaller than a laptop – that can hold up to eight nasopharyngeal swab samples at a time. The test provides a digital readout of the results in two to 15 minutes – with strong positive results taking closer to two minutes and negative results coming back in 15 minutes.
The test is designed to detect SARS-CoV-2 nucleocapsid protein antigen in individuals with active infections. It was developed in partnership with the Queensland, Australia-based digital diagnostics company Ellume Ltd. and utilizes that company’s nanoparticle fluorescent detection technology.
The Qiareach antigen test uses the same e-hub technology employed for Qiagen’s SARS-CoV-2 antibody test, and the platform allows both antigen and antibody tests to be run simultaneously, a feature the company is touting as being critical once SARS-CoV-2 vaccines are introduced.
Qiagen, based in Hilden, Germany, has begun marketing and distribution of the antigen test in the U.S. and has submitted an emergency use authorization (EUA) request to the U.S. FDA. The company also applied for CE-IVD marking in the EU, something that is expected as early as the end of the year.
Pricing for Qiareach is dependent on scale, but is “competitive with comparable systems,” Jeff Boyle, Qiagen’s global head of franchise immune monitoring, told BioWorld in an email.
The Qiareach antigen test is designed for portability, with a small, battery-operated hub that can be connected remotely to a laboratory’s information management system with optional use software.
While the potential uses of the testing system are broad, it must be operated by a health care professional. The higher throughput of the system is aimed at laboratories but could have applications in decentralized settings, such as schools, Boyle said. The company plans to amend its EUA with a point-of-care claim later this year.
The other element that sets the SARS-CoV-2 test apart is its digital readout. The digital display does not require subjective interpretation by the technician, according to Qiagen. Also, the results are saved and can be checked later, rather than having to observe them manually at the time the test is completed. The FDA recently sent a letter to health care professionals about the potential for false positive results on SARS-CoV-2 antigen tests when users fail to follow the instructions for use. In particular, the agency reminded providers that “reading the test before or after the specified time could result in false positive or false negative results.”
Overall, the antigen test as a sensitivity of 90% and a specificity of 100% in testing of clinical samples, according to Qiagen. The company did not provide details on the clinical testing.
The Qiareach antigen test is part of a larger portfolio of COVID-19-related testing products, including an antibody test and PCR testing.
Additionally, Qiagen recently signed a research license and option agreement with Waltham, Mass.-based Tscan Therapeutics Inc., to develop T cell-based laboratory tests to detect prior exposure to SARS-CoV-2. Under the agreement, Qiagen can license the rights and intellectual property for Tscan’s immunodominant T cell targets, associated sequences and relevant data for the development and commercialization of in vitro diagnostic tests.
In an Oct. 28 earnings call, Qiagen CEO Thierry Bernard said the company expected the first revenue contribution from the antigen test in the fourth quarter of 2020.
Qiagen reported third-quarter 2020 sales of $438.8 million, up from $382.7 million during the same period in 2019, an increase of 26% at actual and constant exchange rates. The adjusted EPS rose 61% to $0.58.
Based on expectations of 24% to 27% CER sales growth in the fourth quarter, Qiagen increased its full-year 2020 outlook to about 20% CER sales growth, with an adjusted EPS growth of 45%.
In an analyst note on the earnings, Julie Utterback of Morningstar Equity Research maintained the company’s fair value estimates at $38 per share. “Like many companies in life sciences that have seen a boost from COVID-19-related demand and an intra-sector rotation due to policy concerns in other areas of the healthcare industry, we view Qiagen’s stock as rich,” Utterback wrote.