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 At the heart of the crisis is a reliance by public and private labs
on automated testing equipment that locks them in to using
proprietary chemical kits and other tools made by a handful of
manufacturers.
The result: as infection rates spike nationwide, many labs aren't
running anywhere near capacity because of supply-chain bottlenecks,
according to Reuters interviews with 16 hospital, state, commercial
and academic labs and an analysis of state and city procurement
plans.
A few companies – Cepheid, Hologic Inc, Roche and Abbott
Laboratories – dominate this market. Their machines run on chemical
kits and disposable plastic parts like sample plates and pipettes
that only they sell, much like branded printer cartridges.
"The vendors are in an impossible situation right now where they
can't say yes to everyone," said Geoffrey Baird, who runs the
medical laboratory at the University of Washington.
U.S. labs now run about 800,000 diagnostic tests daily, according to
the COVID Tracking Project. But the United States needs 6-10 million
tests per day, by various estimates.
Congress has earmarked $11 billion to support this drive, and in
May, states filed plans with the government describing the equipment
and supplies they would buy.
But taken together, the plans show that public health officials are
not addressing the core supply-chain problem, according to the
Reuters analysis.
Many states planned to buy more of these automated machines from
just two manufacturers, even though the same equipment was already
running below capacity or idled in other states because of shortages
of chemicals or parts.
Other countries, including China and Canada, have not been hamstrung
to the same extent by supply shortages. Their use of less automated
testing provided more flexibility in sourcing such materials.
NO SIMPLE SOLUTION
Early in the pandemic, testing looked similar globally. Lab workers
would extract genetic material using one instrument, and then move
to a second machine to identify it. But such multi-step tests are
labor-intensive and require technical expertise.
Many U.S. labs now rely on the highly automated - or
"sample-to-answer" - analyzers. But some experts say this has proved
inadequate because of a lack of standardized chemicals and parts.
Gary Procop, who helps lead the Cleveland Clinic's labs, said the
government could have used the Defense Production Act (DPA) to scale
up multi-step tests, using existing instructions from the Centers
for Disease Control and Prevention.
"That uses really standardized reagents," Procop said of the CDC
test. "You could make that in a generic form, if you will, and take
the companies out of it. And then you could actually mass-produce
that type of a test. But nobody's done that."
The U.S. Department of Health and Human Services told Reuters the
government had used the DPA to buy some testing supplies, but
reagents used to run the CDC test are already available, so buying
more would not help.
"As a result of working directly with companies to improve their
supply chain, eliminate barriers, and investing through the DPA, we
do expect supplies of each of these platforms to increase in the
fall," spokeswoman Mia Heck said in a statement.
Health experts also caution there is no single, simple solution to
testing in a once-in-a-century pandemic that has infected more than
16 million people and killed more than 640,000 worldwide.
In China, combining patients' samples to save supplies made it
possible to test millions of Beijing residents in June, beating back
a resurgent outbreak. But experts warn this method can increase
false negative results and be ineffective when disease is prevalent.
Canada has built up a domestic supply chain for chemicals in
multi-step tests, meaning most patients can be diagnosed within a
few days. Yet this regime is more viable in a country with a
fraction of the U.S. population.
"When you're asked to process more than 1,000 samples a day - or
more than 4,000 as we are now doing - you have to do some of it on
sample-to-answer platforms," said Alex Greninger, assistant director
of University of Washington Medicine Clinical Virology Laboratories.
A RUN ON PANTHERS
By late April, Hologic, Cepheid, Roche and Abbott were all selling
COVID-19 tests for their automated machines. Lab workers could load
samples into the devices, sometimes hundreds at a time, and walk
away.
Those companies became critical to the U.S. response. A May survey
from the Association for Molecular Pathology (AMP) showed 47% of
labs listed one of them as its primary COVID-19 testing system.
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For states seeking to boost testing capacity, the most sought-after machine has
been Hologic's Panther, which can process up to 1,000 tests in 24 hours, state
filings show.
"The demand has been amazing. We feel very proud of the role we're playing,"
Hologic CEO Stephen MacMillan told an investor conference in June.
The company "had virtually every governor in the U.S. just talk to us directly
over the last few weeks, months, pleading their case for why they need more," he
said.
Twenty nine states and cities planned to buy a total of at least 51 Panthers,
which are also used to test for HIV and other infections. Officials in
Washington and North Carolina told Reuters they were still waiting on delivery.
However Hologic is not making enough COVID-19 kits to run on its existing
machines - about 1,100 across the country - at capacity. At full tilt, the
machines could process about 33 million tests per month, but the company makes
roughly 4.8 million.
Hologic said its manufacturing teams were working around the clock while it
hires more people and invests in new equipment to increase production. The
company said it had already made "a huge contribution" to testing, making it
possible for labs to generate more results with less hands-on time.
The runner-up in states' plans was Cepheid, with 45 of its GeneXpert machines on
wish-lists. The company, which has about 25,000 machines worldwide, is making
about 2 million tests per month - enough to run two or three tests globally per
machine each day.
Cepheid is focusing on customers that need rapid results, like hospitals, said
Chief Medical Officer David Persing. It is working on millions of new cartridges
but does not expect a dramatic supply boost until mid-2021.
'WE WENT TO THE BUFFET'
This month, Arkansas congressional leaders warned in a letter to Vice President
Mike Pence that their state's hospitals were testing at 10% of capacity. There
are shortages of key supplies from Roche, Abbott, Cepheid and Hologic, said the
state's medical director of infectious diseases Naveen Patil.
Roche told Reuters its automated equipment reduces errors, frees up staff and
returns results more quickly. The company said it is increasing production
capacity, and is "very intentional" about where it sends tests and instruments.
Abbott said it is expanding capacity, and closely managing supply to ensure
tests get where they are needed.
Some labs have managed shortages by buying instruments from different vendors,
so they can take advantage of whichever vendor's supplies are available. But
that also means they run below capacity, according to the Reuters interviews.
The AMP survey found 57% of labs were running tests on at least three companies'
machines.
"It's pretty much like we went to the buffet and got one of everything," said
University of Washington's Baird, whose lab runs most of the state's tests.
But as cases spiked in more than 30 states this month, some labs became
overwhelmed as they struggled to get chemicals and disposable parts.
In the months ahead, separate antigen tests and gene-sequencing machines could
boost capacity. The National Institutes of Health is working with companies to
reach at least 6 million tests per day by December.
Some labs are also turning to suppliers of multi-step tests.
New Jersey's RUCDR Infinite Biologics can run 50,000 samples a day in two steps.
Arizona's Sonora Quest recently announced a plan to run up to 60,000 tests a day
using similar equipment.
Gary Kobinger, a Canadian researcher best known for his work on Ebola, argues
that all diagnostics should be done on open platforms.
"At one point there will be a new pathogen, and the company that makes the
cassette that is controlling everything is not going to be able to supply you,"
he said.
"And this is where we are now, right?"
(Reporting by Allison Martell in Toronto and Ned Parker in New York; Additional
reporting by John Miller in Zurich, Roxanne Liu in Beijing and Matthias Blamont
in Paris; Editing by Michele Gershberg and Pravin Char)
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