The FDA so far this week has granted Abbott (NYSE:ABT) two emergency use authorizations (EUAs) allowing diagnostic and antibody tests to run on the company’s Alinity systems.
The agency today authorized Abbott’s COVID-19 molecular diagnostic test for use on its new Alinity m molecular laboratory instrument. Abbott said it has begun launching the Alinity m system to U.S. customers.
Yesterday, the FDA granted the Abbott Park, Ill.-based company’s SARS-CoV-2 IgG lab-based serology blood test an EUA for use on a second testing platform, the Alinity i. Abbott won an EUA and the CE Mark for a SARS-CoV-2 IgG serology blood test for use on its Architect system in April.
The FDA cleared the Alinity m system for use with Abbott’s HCV (hepatitis C) assay in late March. Abbott said it is working with hospitals and health systems in the U.S. to install this new instrument, which will help keep up with the growing demand for testing.
The company described the Alinity m system as its most advanced laboratory molecular instrument. It is an automated platform, which can run more tests in less time — up to 1,080 tests in 24 hours, Abbott noted. The company’s m2000 RealTime system can run up to 480 tests in 24 hours. Federal and state officials criticized the testing capacity of certain Abbott systems last month.
Abbott said today that running different types of tests on current systems simultaneously will slow down the time to results and/or volume throughput. Alinity m allows labs to run any test at any time for different types of infectious diseases while still providing results in less than two hours, the company said.
Monday’s EUA allows laboratories to run Abbott’s IgG lab-based serology blood test on its Alinity i system. Serological tests are needed to show who has developed antibodies and possible immunity to the COVID-19 virus, although no one has shown how long such immunity may last or how protective it may be. Pressure to increase serological testing has been mounting as more people have recovered from the virus and demands to reopen the country intensify.
The Alinity i system is Abbott’s latest immunoassay instrument, designed to offer greater efficiencies to lab clinicians running tests. Alinity i systems are in use around the world in hospital and academic centers as well as reference laboratories.
Abbott said it plans to ship nearly 30 million of the antibody tests globally in May for use on Architect or Alinity i, and said it will have capacity for 60 million tests in June. The company also plans to apply for the CE Mark for its Alinity i SARS-CoV-2 IgG test this week and will begin global shipments immediately. And it expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.
Abbott said data show reliable results from the serology tests run on Alinity i, with 99.6% specificity and 100% sensitivity for patients tested 14 days after symptoms began. The reliability of many COVID-19 antibody tests has been questioned, prompting the FDA on May 4 to reverse a policy that had allowed manufacturers of COVID-19 antibody tests to self-validate those tests. Now manufacturers must prove the tests’ accuracy to the agency before they can begin marketing them. Companies that were selling tests without proper validation must submit their validation information to the FDA this week or risk having the tests pulled from the market.
“Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19,” said Abbott president & CEO Robert Ford in a news release. “Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity.”