Qiagen to launch rapid coronavirus test it says could be used in airports and stadiums
- The company said it plans to launch two versions of the antigen test in the U.S. later this year: one version that's meant to be processed in a clinical laboratory and another that's portable and can be processed at point of care.
- The company has not yet applied for emergency use authorization from the Food and Drug Administration but said it plans to.
- If the test is granted FDA authorization and if it's waived from the requirements under the Clinical Laboratory Improvement Amendments, Qiagen said, the test could be used in high-volume settings such as airports and stadiums to test people with symptoms.
German genetic testing company Qiagen announced Tuesday that it plans to launch a new antigen test for the coronavirus that it says could eventually be deployed in airports and stadiums if it receives the appropriate authorizations.
The company said it plans to launch two versions of the antigen test in the U.S. later this year: one version that's meant to be processed in a clinical laboratory and another that's portable and can be processed at point of care. The company has not yet applied for emergency use authorization from the Food and Drug Administration but said it plans to.
If the test, called the Access Antigen Test, is granted FDA authorization for point-of-care use and if it's waived from the requirements under the Clinical Laboratory Improvement Amendments, Qiagen said, the test could be used in high-volume settings such as airports and stadiums to test people with symptoms. Rapidly testing symptomatic people could become increasingly important in the fall and winter as seasonal influenza, which causes many of the same early symptoms as seen in Covid-19, spreads in the Northern Hemisphere.
"The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking," the company said in a release.
The test, which was developed in collaboration with Australian diagnostics company Ellume, can screen up to eight nasal-swab samples simultaneously, the company said. Administrators of the test use a small digital platform, called an eHub, which was launched in August with Qiagen's antibody test, to process the nasal swabs.
The platform can yield results in less than 15 minutes, the company said, and can process an average of about 30 swab samples every hour. Qiagen added that the test correctly diagnoses a positive coronavirus infection 90% of the time and correctly diagnoses a negative result 100% of the time. The company did not elaborate on the methods used to arrive at the accuracy conclusions.
The company has not yet disclosed a price point for the test, but Qiagen CEO Thierry Bernard called the tests "cost-effective." Qiagen also did not disclose details on how many tests it will be able to manufacture.
In a statement, Bernard added that the antigen tests are meant to supplement, not replace, the molecular, or PCR, tests, which are the most accurate tests on the market. PCR tests, however, are dependent on a strained supply chain of technical laboratory equipment, need to be processed by trained scientists and can take hours or days to yield results.
The company added that it will also apply for certification in Europe.
"The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence," Bernard said in a statement. "It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound."
— CNBC's Meg Tirrell contributed to this report.