TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.

“(W)e have been working around the clock with provinces and territories to make sure everyone has what they need to continue to detect and interrupt the chain of transmission,” Canada’s health minister Patty Hajdu said. “Early diagnosis is a critical component, so we are taking extraordinary measures to help make that happen as quickly as possible.”

Speed at a premium

COVID-19 derives from Severe Acute Respiratory Syndrome or SARS-CoV-2 infection which is a strain of a larger coronavirus family; hence, the derivation contained in the name of the kit developed by Roche for COVID-19, Cobas SARS-CoV-2. The test came about as a result of Roche’s monitoring of research on potentially epidemic pathogens, notably attempts by Chinese labs to corral COVID-19 in recent months. This was followed by work performed on the Chinese molecular sequence by Roche scientists in California.

The key, Roche’s Canadian medical affairs director Michele D'Elia told BioWorld, is the speed of real-time reverse transcription polymerase chain reaction or RT-PCR testing compared to standard serology. “It’s quicker to engineer at the molecular level than come up with the right antibody, specific protein or antigen from the blood for the test,” said D'Elia. “For us it meant getting to market in a matter of weeks rather than months.”

Getting things out the door quickly was also vital on the regulatory side, said D'Elia. Clinical studies that can take several months involving many thousands of samples before getting the nod in Canada or the U.S. were condensed into a matter of days or weeks.

“There has to be a balance between the time required to do a lot of studies and doing what your product needs to be recognized by health authorities as an accurate test,” said D'Elia. “Their intent has been to commercialize this as quickly as possible.”

This was accomplished by “running the studies that were required for today’s needs,” D'Elia added, but also by regulators "who have really reinvented the way they authorize these tests. Within a weekend they did something I have never seen before.”

Stable border controls

Manufactured at Roche’s facilities in Branchburg, N.J., the kits are shipped to a central distribution hub in Indianapolis where they are transported across North America, including to Roche’s distribution facility in Laval, Quebec. To date, Roche products have freely crossed the U.S.-Canada border, and shipping its COVID-19 test will be no different, said D'Elia.

Despite the high premium placed on American companies to treat U.S. citizens, Canada and the U.S. announced March 20 unimpeded trade between the two countries would continue. That remains something beyond his company’s control, said D'Elia, as do U.S. rumblings about a thousand U.S. soldiers being deployed along the world’s longest undefended border.

“Now we’re entering the political scheme of things which is highly unpredictable,” said D'Elia. “The one thing I can tell you that is predictable is our transportation routes. Right now, everything is secure. Things get out to our customers with no particular delays just as they always have.”

For its part, Thermo Fisher Scientific said it hit the ground running in response to COVID-19, developing a new multiplex real-time RT-PCR diagnostic kit to quickly diagnose COVID-19 linked to SARS-CoV-2. Thermo Fisher has declined to comment directly to reporters, however, instead issuing statements on its efforts to supply Taqpath COVID-19 Combo Kits.

“It is important that we avoid unnecessary risk or disruption to our sites which are critical to the ongoing operation of our business,” Thermo Fisher’s senior public relations director Ronald O’Brien told BioWorld. The firm has assembled a corporate incident response team which it said has stressed the use of best practices when assessing exposure risk to COVID-19 and shifting resources from prevention to containment or recovery.

Thermo Fisher’s promise, said O’Brien, is that “businesses continue to meet customer expectations for product supply and availability.”

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