Coronavirus testing giant performs high-wire act of promises vs. reality

Coronavirus testing giant performs high-wire act of promises vs. reality

President Trump’s made-for-TV unboxing of Abbott Laboratories’ toaster-sized testing instrument beamed into millions of households last month as he displayed the unit in the Rose Garden.

The marketing boon signaled the emergence of Abbott as a frontrunner in the arms race to develop what the current and former FDA commissioners have called “game-changing” tests. Broadscale coronavirus results could allow Americans to return to normal armed with knowledge of the disease’s spread.

Realities in labs and clinics across the country show that even the most promising test improvements still trail the massive surge in diagnostics the country needs, according to those who have been denied access to prompt testing – and even those able to get their hands on the Abbott machines. In frustration, many are striking out on their own.

President Trump called the 6.6-pound ID NOW instrument “a whole new ballgame." It delivers positive tests in five minutes and negatives in about 13.

Trump and those around him pressed the portable ID NOW units into service at the White House this week, with Trump saying he took the Abbott test on April 3 and was negative. Visitors expected to be near the president or the vice president are being given the rapid nasopharyngeal swab test, including members of the press corps attending the daily task force briefing.

In the outside world, experts say rapid tests likely will play a smaller role, one more often aimed at the sickest patients who stand to benefit most from the five-minute positive results.

“These tests are much lower throughput, but for the sickest patients in the ICU or arriving in the emergency room you want that result sooner than hours or days,” said Frederick Nolte, director of clinical laboratories at the Medical University of South Carolina.

President Donald Trump opens a box containing a 5-minute test for COVID-19 from Abbott Laboratories as Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks about the coronavirus in the Rose Garden of the White House, Monday, March 30, 2020, in Washington.

Even inside Abbott, the message has been much more subdued than the administration's hype. Spokeswoman Darcy Ross said the company and its CEO have been careful not to overpromise, acknowledging their point-of-care rapid tests will only be a part of a testing solution for coronavirus and are aimed at health care workers and first responders.

Allocation of the sought-after instruments and the tests that feed them has been done in coordination with state and federal officials, but "customers ultimately determine how our tests are allocated," Ross said.

So far, the company has shipped about 500,000 of the rapid tests, which run on instruments that sell for $4,500 apiece, to all 50 states, Washington D.C., Puerto Rico and the Pacific Islands. In addition, it has shipped about a million tests worldwide that run on a different instrument – m2000 RealTime molecular lab tests – to the more than 200 already-operational machines nationwide. Those tests take about eight hours to return results.

“We see it as part of the broader testing landscape for COVID," Ross said. “We need testing and Abbott is doing its best.”

Instruments a “game changer” for some, hard to come by for others

After Abbott’s news release announcing emergency FDA approval of its ID NOW test for coronavirus, current FDA Commissioner Steve Hahn called the devices a “game changer” in rapid diagnostics.

“This is big news and will help get more of these tests out in the field rapidly,” he said.

Former FDA Commissioner Scott Gottlieb echoed that sentiment with an all caps GAME CHANGER tweet that gained significant traction March 27 among his nearly 300,000 followers.

Detroit Mayor Mike Duggan told The Washington Post that he had obtained the cell phone for Abbott’s CEO and called directly to get hands on the new machines, which he also said would be a “game changer,” clearing first responders and nurses to return to work.

And, four weeks after Trump hosted drug store CEOs at the White House to announce a vision of drive-through testing in retail parking lots, Walgreens and CVS both announced partnerships with Abbott to operate drive-through tents.

Walgreens operates 9,200 drugstores nationwide, but said it was deploying Abbott’s technology initially at just 16 total locations in seven states: Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas. Representatives from the chain declined to answer questions this week about how the locations were chosen or how soon more would be added.

Amid all the publicity, James Yost – the chief medical officer of CRH Healthcare – wanted the Abbott portable machines immediately. His company manages 45 urgent care clinics in four states, including Georgia.

He quickly learned that he’d have to wait at least a month.

ID NOW test components being made in Abbott’s U.S. manufacturing facility

The Georgia Department of Health is not using the Abbott tests either. A spokeswoman there noted that only one test can go through the ID NOW machine at a time, limiting it to dozens of tests a day. By contrast, LabCorp, Quest and Abbott’s slower machine can process thousands of tests a day.

The national testing bottleneck persists as the number of people infected have grown exponentially and untested samples pile up. Quest acknowledged recently that it had a backlog of 115,000 tests with an average wait for results of four to five days. LabCorp acknowledges a similar wait for results.

Providers say some waits are even longer. Dr. Robert Hart, the chief medical officer of Oschner Health, said the largest health-care system in Louisiana had briefly used Quest and waited as long as 16 days.

Quicker results allow people suffering from the disease to take appropriate action, including quarantining themselves. And for patients admitted to hospitals, quick turnarounds allow nurses and doctors to avoid wasting scarce face masks and robes around patients who are not contagious.

Major hospitals are taking matters into their own hands. In Atlanta, Grady Health and Emory Healthcare, recently decided to start testing in-house, getting results for patients in just a few hours. The Cleveland Clinic in Ohio is now testing 1,300 samples a day with a turnaround of eight hours, CEO Tomislav Mihaljevic told MSNBC.

Oschner has several of the Abbot ID NOW instruments currently in use. The same technology rapidly detects influenza and strep throat.

But Hart said the five-minute test will be limited to specific situations, such as testing patients who walk into the emergency room, women delivering babies or patients going into surgery. In most other cases, he said, it’s not critical to have an immediate result.

Alex Billioux, assistant secretary of health for the Office of Public Health in Louisiana, said the quick tests could be useful for places like nursing homes.

Oschner will continue to do most testing in their own laboratory, Hart said, which can handle the needed high volumes. Currently, the system is doing about 1,000 of its own tests a day, with a turnaround of 24 hours.

“I think a lot of hospitals were trying to bring it in house,” Hart said, “because the value of the quick turnaround is huge.”

Rocky start to Abbott’s acquisition of company that created the test

Abbott’s ID NOW technology was developed by Massachusetts medical device manufacturer Alere Inc. and acquired by Abbott in 2017 in a $5.3 billion deal that nearly imploded.

After coming to terms on the purchase, Abbott’s then-CEO, Miles White, soured on Alere when a series of negative reports surfaced, including a federal fraud probe into Medicare and Medicaid billing.

White wanted to nix the deal so much he that offered $50 million to get out of it. Alere sued in 2016 to enforce the agreement, Abbott responded with a counter-suit. The two stood down in 2017 before the cases went to trial.

Since the president put Abbott on the national stage, investors have boosted the company’s stock price 35 percent.

Testing being performed on Abbott’s ID NOW platform.

Wall Street analysts say coronavirus testing will add $1 billion to the Illinois company's revenue this year. While slowdowns in other health sectors will dent Abbott’s growth, projections still show the company emerging from 2020 with $34 billion in revenue.

The rocky acquisition of Alere and its ID NOW tests look fortuitous in hindsight, said Edward Jones analyst Ashlyn Evans. She said despite public attention and the crush for development she expected Abbott to take advantage of a global footprint in the months ahead.

“Headlines can be flashy, but they are developing lots of different tests,” Evans said. “As a leader in point-of-care diagnostics this huge demand will only benefit Abbott.”

Abbott points to its long history with diagnostics in health emergencies. It developed the first FDA-approved test to screen blood donors for HIV in 1985.

The company’s roots trace to 1888 and Wallace Abbott’s pharmacy and remedy development in Chicago. The company cranked out penicillin during WWII, acquired popular baby formula brand Similac in the 1960s, developed the well-known immunosuppressive drug Humira in 2002, and has recently been on the cutting edge of continuous glucose monitoring for diabetics.

Abbott spun off its pharmaceutical development with the creation of sister company AbbVie in 2013. But despite that spinoff, the company still endured some ugly investigations into its work with anticonvulsant drug Depakote and other products.

In 2012, Abbott pleaded guilty and agreed to pay $1.5 billion in criminal and civil liability tied to unlawful promotion of Depakote to elderly dementia patients in nursing homes. In 2018, Abbott and AbbVie also paid $25 million to settle with the federal government over allegations the company had employed kickbacks and unlawful promotion of the anti-cholesterol drug TriCor dating back to 2006, before the split.

Abbott’s other ‘workhorse’ may be more useful for some

While the White House continues to promote Abbott’s five-minute test, the company's other testing instrument, the m2000, could end up playing a much bigger role in addressing the scarcity of testing.

American labs rely on about 200 of the m2000 machines nationwide for various other tests like HIV and hepatitis. Oschner, which has one in Louisiana, is considering buying a second.

In South Carolina, the machine is seen as a workhorse, said Nolte, the Medical University lab director. He uses the machine to do about 500 coronavirus tests per day.

Nolte said he called Abbott to order an ID NOW test instrument and was told it would be unavailable since the units were first shipping to hardest-hit states. Nolte heard the same from Cepheid, which has produced its own rapid test. He also says a third company, BioFire Diagnostics, will be competing for the rapid testing market in t coming weeks.

Journalist Brian Fuss holds up COVID-19 testing information after receiving a coronavirus test by the White House Medical Unit before attending a news conference with President Donald Trump in the press briefing room at the White House, Thursday, April 9, 2020, in Washington.

As of Friday, the FDA had received applications for more than 270 test developers and already granted emergency use authorization to 32 for new diagnostic tests.

Though he sees developing technology and capacity moving in the right direction, Nolte worries the FDA’s emergency authorizations for the companies could have negative consequences.

He said the tests’ true sensitivity and specificity to the virus is unknown without comparing them in rigorous testing. A flood of false positives and negatives could lead to disastrous public health outcomes.

“The FDA tried to lock this down and put down some guard rails, then things with the virus were getting out of control and a lot of fingers started being pointed about the lack of tests,” Nolte said. “That pressure and all the publicity led to the FDA and White House starting to take the guardrails off.

“I don’t know how to say this and not sound like I’m on both sides of the fence—but we’ve gone too far. It’s frightening.”

David Heath and Nick Penzenstadler are reporters on the USA TODAY investigations team. Contact David at dheath@usatoday.com, at @davidhth, or on Signal at (240) 630-1962 and Nick at npenz@usatoday.com, at @npenzenstadler or on Signal at (720) 507-5273.

Source: https://www.usatoday.com/story/news/investigations/2020/04/13/abbott-labs-live-up-coronavirus-testing-expectations/2941027001/

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