Johnson, Trump want virus tools that aren’t ready yet

Bloomberg

UK Prime Minister Boris Johnson, US President Donald Trump and other leaders want to ramp up coronavirus testing. There’s just one problem: Providers of the diagnostics can’t make enough kits to keep up with demand.
The UK will soon be testing 25,000 people a day for the virus, Johnson said at a press conference, and that could eventually rise to 250,000. He also touted a potential “game changer” — a different kind of test that can tell whether people have been exposed to the virus and developed antibodies against it, potentially giving them immunity.
So-called antibody tests are still in the study phase, though findings from a review posted this week suggest researchers are making progress. And the other kind of diagnostic, showing whether someone is currently infected, is in short supply.
Qiagen NV, which makes its own testing kits as well as the components others need for theirs, is having to ration clients while it works to ramp up production as much as 80% in two months. Roche Holding AG’s new high-speed tool that can spew out more than 4,000 results a day is going to places most in need — but not to every lab that could benefit from having it.
The struggle may leave doctors and epidemiologists unable to perform tests to assess the true scope of the unfurling pandemic. That ratchets up the challenge facing countries from Europe to North America — many of whom have watched the outbreak swell in part because of their inability to test people early on. By contrast, South Korea offers an example of how a campaign of widespread testing has helped officials more effectively quarantine and isolate people and put a lid on Covid-19’s spread.

Testing Is Key
“Testing is essential,” David Nabarro, the World Health Organisation’s special envoy for coronavirus, said by email. “Unreliable data means that we navigate blindly and this undermines the public health response.”
Trump, whose administration has previously vowed to ramp up testing dramatically, said at a White House press conference on March 19 that the US’s diagnostic situation is “starting to work out very well” — even as he cautioned that people should only get tested if they’re showing symptoms.
Trump also touted the malaria drug chloroquine as a possible treatment, though the Food and Drug Administration hasn’t approved it for use in Covid-19 patients. US doctors, however, are legally able to prescribe a drug for any illness or condition they think is medically appropriate.
German drugmaker Bayer AG said it is donating 3 million doses of Resochin, its off-patent formulation of chloroquine, to the US for coronavirus treatment. Bayer is working to get Emergency Use Authorisation for Resochin, according to an emailed statement.
Meanwhile, the UK Bioindustry Association is urging the life sciences sector to help the government increase the supply of testing kits and components including swabs, vials, biohazard packaging and alcohol wipes.
Thermo Fisher Scientific Inc, which has agreed to buy Qiagen, has 1.5 million tests available to ship and expects to quickly ramp up to reach 2 million per week, spokesman Ron O’Brien said by email. The company expects to lift production to 5 million per week in April.
Qiagen says it hasn’t run out of stock and it expects to be able to produce more than 20 million kits by mid-April, an increase in output of about 70%.

“We’re trying to meet the demand as best we can,” Chief Executive Officer Thierry Bernard said by phone. Qiagen’s supply chain is undergoing “extreme tension.” Everyone in the industry is “making extraordinary efforts in terms of production increases.”
Automated System
Roche is capable of producing 8.5 million tests a month, with almost half of those running on its fully automated systems that won emergency use approval in the U.S. last week. The Swiss company has been working with regulators to make sure its instruments are getting sent to the most in-need locations. The sheer demand for tests is vastly outpacing supply, CEO Severin Schwan said.
“Testing is really targeted for high-risk patients and patients who show signs and symptoms of the disease,” Schwan said Thursday on a pharma industry media call. “Broad-based testing at this stage is simply not feasible.”
While it’s smart to test the sickest people first, the inability to test widely means public health officials aren’t getting a full picture of who is sick — especially since some people develop no symptoms while others only suffer a small amount.
That’s where tests for antibodies to the virus, also known as serological testing, could be helpful. British company Attomarker Ltd. said its technology will support tests that last only 5 minutes and look for certain antibodies in patients’ blood.
Instead of looking for current infections with the virus, these tests can screen for previous exposure to Covid-19, which could help scientists determine who’s already recovered from the disease and potentially developed immunity.
“It’s even more important to help us understand the epidemiology of this virus,” said Rajeev Venkayya, head of the vaccines business unit for Takeda Pharmaceutical Co., on the press briefing.