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Abbott Plans Additional Tests, Manufacturing Increases to Meet SARS-CoV-2 Demand

NEW YORK – On a conference call discussing its first quarter earnings results on Thursday, Abbott Laboratories outlined its continuing plans for developing and manufacturing SARS-CoV-2 tests and said it was hoping to ramp up production to at least 5 million tests in April.

Abbott has two molecular diagnostic tests cleared for Emergency Use Authorization by the US Food and Drug Administration, the PCR-based RealTime SARS-CoV-2 test and rapid point-of-care ID Now COVID-19 test. The company committed to manufacturing 50,000 ID Now tests per day beginning in April, and according to President and CEO Robert Ford, the company has at least met that goal every day so far and has beaten the number several days. He added that the company is aiming to manufacture 2 million ID Now tests by June.

In addition to its molecular tests, Abbott also announced this week a coronavirus serology test for the detection of IgG antibodies on its immunoassay platforms. The company intends to ship 4 million serology tests in April, and ramp capacity up to 20 million tests per month starting in June, Ford said on the conference call. He added that since the announcement on Wednesday, Abbott had received orders for about 1 million of the antibody test. 

Ford also noted the company is in the process of developing a second serology test, a lateral flow assay to detect IgM antibodies, which is expected to launch in the near future. The test, he said, will increase Abbott's ability to provide mass testing for the general population. 

The development of these tests began in the middle of February, Ford said, when Abbott realized the SARS-CoV-2 virus was not going to follow previous virus patterns, such as the 2003 SARS virus. The company developed four separate research and development teams, each tasked with working on a specific type of test: two molecular, two serology.

The company didn't start working on the tests because "we thought that we needed four shots on goal here to try and get one or two of them," to market, but because "all four of these different types of testing would be needed," Ford said. 

"All four had a different value proposition," he added. The RealTime SARS-CoV-2 test, which runs on the m2000 RealTime instrument and is for use in a laboratory, provides higher throughput and larger test volumes, but with a longer turnaround time, while the rapid ID Now test offers faster results with more portability, Ford said. As for the serology tests, the company knew there would be a need for mass volume screening as the virus continued to spread.

"There's a viral progression that occurs," Ford noted. "In the early stages, you need molecular testing to be able to diagnose if somebody has the virus, and as the disease progresses and people start to build antibodies to that, you're going to need a different type of test."

According to Ford, every R&D team met or beat their target launch date, with one of the teams splitting in two so they could work all 24 hours in a day.

Abbott also worked closely with the FDA on developing its tests, providing updates to the agency at every step of the development process and accepting real-time feedback.

Ford noted that there have been difficulties for patients attempting to access COVID-19 tests, including shortages in sample collection materials, but he emphasized that Abbott's test rollout was going as expected. Distribution of the rapid point-of-care ID Now tests began with front-line healthcare workers, so they would know in 15 minutes if they had to self-isolate or if they could return to work, which was "exactly how we envisioned that product to work, at least in our initial rollout," he said, adding the ID Now COVID-19 test is also the same price as the ID Now Influenza test. 

In the coming months, Abbott is moving toward a second phase for the ID Now coronavirus tests to expand them to the general public. The company is working on pilot programs with retail pharmacy CVS and other retailers to strategize how to decentralize testing and provide point-of-care tests in urgent care clinics, nursing homes, and retail settings.

For the PCR test, Abbott shipped its m2000 instruments to areas where the capacity was so low that it typically took labs two weeks to return test results, and said that now, results could be provided in 24 hours. In March, the company distributed 1 million of those tests and is on target to manufacture 4 million tests in April.

"We've done everything that we said we were going to do, we delivered everything that we said we were going to deliver," Ford said. "Obviously, that is not enough, we still need to do more, and there's a need here to manufacture more tests."

Abbott is working to scale up its manufacturing, but Ford noted that the high-precision processes and the manufacturing lines takes time to set up, although the company has been able to use some of its existing assets to further increase manufacturing abilities.

The company is also "actively working with government authorities and health systems to deploy these tests to places of greatest need," Ford said. Abbott provides daily reports to state and federal governments on where tests and equipment has been shipped to help allocate tests to hardest-hit areas, he added.

Despite the benefits of being a major SARS-CoV-2 test provider, the COVID-19 pandemic has negatively impacted Abbott's core lab business, since there have been decreases in routine testing and elective procedures. Ford said he expects those impacts to continue throughout the second quarter, but that in the second half of the year volumes should recover slightly. "I don't believe that they’re going to come back at the same speed they came down, but these are important procedures and I do see them coming back," he said.