Ottawa Citizen

The cruel math of COVID-19 testing

Having enough kits in hand to get ahead of the curve won’t be easy

- JAMES BAGNALL

The calls coming into Spartan Bioscience have come out of the blue, tinged with desperatio­n. Certain U.S. states and hospitals are so eager for the Ottawa firm’s COVID-19 testing technology they are offering to buy Spartan’s entire future production.

As a businessma­n, company founder and CEO Paul Lem is tempted. As a Canadian, he is concerned. “We want to serve our country,” he says, “I know the (Canadian) government is really working hard on this, but we need purchase orders now.”

These could come any hour, such is the speed at which things are moving. Spartan is one of those rare companies that happens to be in the right place at the right time. The company has spent 14 years developing portable DNA testing technology now being directed at the war against the COVID-19 virus. Unlike most other COVID-19 test kits, Spartan’s offers results in less than 45 minutes because the data doesn’t need to be processed by a laboratory. It can be done on-site.

The Spartan test kits aren’t quite ready for prime time. The company still has to establish if its product can produce accurate results using the particular chemical ingredient­s specified by the U.S. Centre for Disease Control and Prevention (CDC). This could take a few more days, maybe weeks. Neverthele­ss, a significan­t purchase order would allow Spartan to gear up production of its test kits to be ready as soon as possible.

The company has enough material on hand to produce more than 15,000 test kits but requires significan­t investment to be able to supply the hundreds of thousands of tests that will be necessary.

The fact that Spartan isn’t already producing says much about the frustratin­gly slow rollout of COVID-19 testing across North America.

Like other commercial firms and government labs, Spartan relied on the CDC to develop a diagnostic panel of reagents (chemical compounds) used to detect the COVID-19 virus. It proved a fateful choke point because CDC ran into manufactur­ing problems that would not be resolved until late February.

At that point, dozens of firms and labs began furiously developing COVID-19 test kits based on the CDC recipe. Roche Diagnostic­s, which had been developing a test for the virus since its California unit began monitoring its spread in China in late December, was among the first to receive regulatory approval, along with Thermo Fisher Scientific.

That was on March 13. The formal OK for employing the test kits was granted March 18. Both approvals were done on a temporary, emergency-use basis.

Not coincident­ally, the Canadian branches of these firms were authorized on a similar basis to begin testing here by Health Minister Patty Hajdu. On March 20, Prime Minister Justin Trudeau said his government had signed a letter of intent with Spartan to buy COVID -19 test kits. Cephied, a California rival that also produces portable test kits, won approval around the same time.

The significan­ce of these and similar announceme­nts is twofold. First, it shows the massive potential for expediting the supply of test kits and other essential products. Second, the fact that such a surge is necessary demonstrat­es how much the battle against COVID-19 has changed — from isolating and containing the virus, to massively testing for its presence. The number of new cases is growing so fast, we are now well behind the testing curve. It will require huge effort to get ahead of it.

Roche last week shipped 400,000 test kits and expects to bump up production to 900,000 per week. Thermo Fisher Scientific is ramping up even more quickly. The Boston-based company had 1.5 million test kits available last week and expects quickly to manufactur­e two million per week and, sometime in April, scale to five million tests weekly.

Just what percentage of this increased production will make its way to Canada is a little unclear. Roche did not return calls and Thermo Fisher Scientific said its initially available tests will be distribute­d to about 200 labs in the U.S.

“Allocation will take place based on need,” says company spokesman Ron O’Brien, in reference to subsequent production. Hadju’s spokespers­on declined to answer whether Canada has secured a commitment for a minimum number of test kits.

Certainly the need in both Canada and the U.S. is great. The number of confirmed COVID-19 cases on Tuesday topped 2,500 in Canada and more than 50,000 in the U.S. according to ncov2019. live, a website that is tracking the spread of the virus across the globe.

Testing is absolutely vital in this war. Medical personnel can’t afford to self-isolate for two weeks merely under the suspicion of having contracted the virus. Tests are also needed to keep at home those who are carriers but showing no symptoms. And authoritie­s need to understand more who is most susceptibl­e to COVID-19 and why.

Equally important, for sheer peace of mind, Canadians want to be able to quickly rule out flu and other illnesses they may be experienci­ng.

For the moment, however, there’s a test kit shortage, which means Ottawa residents must meet a stringent series of criteria (contact with a known COVID-19 case for instance) and present with specific symptoms (fever, difficulty breathing) before medical personnel will administer a test for COVID-19. Not only that, the testing operation at the Brewer Park Arena is still taking a week or more to deliver test results, which must be processed through one of the government labs.

Little wonder that Paul Lem and his colleagues at Spartan Bioscience are so anxious to get on with the job of meeting this desperate need.

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Paul Lem

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