The Canadian government has signed an interim order to expedite access to foreign-country-approved COVID-19 testing devices as the World Health Organization amplifies the need for more aggressive testing to fight the pandemic.
In contrast, WHO stated Monday, “The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected. We have a simple message for all countries: test, test, test.”
Minister of Health Patty Hajdu signed the order on March 18, which immediately allows two new devices to be distributed across Canada.
“Early diagnosis is a critical component, so we are taking extraordinary measures to help make that happen as quickly as possible,” said Hajdu.
The Roche Molecular Systems Inc. cobas SARS-CoV-2 diagnostic device and the ThermoFisher Scientific TaqPath™ COVID-19 Combo Kit are now seemingly on their way to provincial health authorities and laboratories, which must order and buy the devices.
Five days earlier, the United States Food and Drug Administration approved Roche’s device from Switzerland with the issuance of an Emergency Use Authorization.
“Early diagnosis and isolation of patients infected with COVID-19 are essential to slowing the spread of the novel coronavirus across Canada. Since the symptoms of COVID-19 are similar to those of a cold or flu, diagnostic testing is important for clinical care and public health management,” stated Health Canada on Wednesday.
The order allows for other virus-testing and virus-fighting devices to be distributed, as the government sees fit.
“With this Interim Order, Health Canada could also look to approvals granted by foreign regulatory authorities in deciding whether to approve an application for the importation or sale of COVID-19-related medical devices. Existing devices, where the approved, intended use was not originally COVID-19-related, could also be expanded under this Interim Order.”
Roche issued a statement March 13 after the FDA approved its device.
“Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the U.S. and around the world.”
As many as 96 test results can come in as little as three and a half hours, said Roche.
The 8800 system can get 4,128 results in 24 hours.
“Upon authorisation Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems. Roche is committed to delivering as many tests as possible and is going to the limits of our production capacity.”
Roche says it presently has just 695 and 132 6800 and 8800 systems respectively.
Like the Roche systems, the Thermo Fisher Scientific systems analyze viral RNA.
“As time is of the essence in responding to this global crisis, we are adapting our regulatory processes to ensure timely access to diagnostic testing medical devices in Canada,” stated Thermo Fisher, a U.S. company.
“Health Canada has completed the scientific review of two diagnostic tests and is ready to accept applications from healthcare professionals for access to it through the SAP.”
It is unknown how many devices can be made and how many are needed at this point in Canada.
Both companies warn that “negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.”
