SARS-CoV-2 testing (COVID-19)

SYDNEY, 19 March 2020 – As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies – including the current COVID-19 (novel coronavirus) global pandemic. During this time, the importance of being able to quickly and reliably detect whether a person is infected with the SARS-CoV-2 virus, cannot be overstated.

The demand for SARS-Cov-2 tests in Australia is unprecedented and our teams have been working relentlessly to meet demands. Roche Diagnostics Australia currently distributes a test for SARS-Cov-2 that local laboratories have been using for a number of weeks now.

On 31 January 2020, the Therapeutic Goods Administration (TGA) granted an emergency exemption to allow tests for SARS-CoV-2 to be used for the COVID-19 public health emergency.

On Thursday, 12 March 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorisation (EUA) for the cobas® SARS-CoV-2 Test.

The cobas® SARS-CoV-2 Test is a new test from Roche, the development of which has been significantly expedited to support the urgent need for patient testing during the novel coronavirus pandemic.

The cobas® SARS-CoV-2 Test detects the virus from patient samples collected via a swab (not provided by Roche) that is then run on the high throughput cobas® 6800 instrument. Results are available in around 3 hours and each system can generate over 1,000 results in 24 hours. These instruments are available in a number of laboratories across all Australian states. The first shipment of the new cobas® SARS-CoV-2 tests arrived in Australia overnight and are being distributed today (Wednesday 18 March). With these two tests available from Roche, it is anticipated that kits sufficient for approximately 100,000 test will be delivered across Australia this week.

Roche will be reordering both test kits frequently, based on Australian patient needs. We will continue to have both tests available in Australia, to ensure maximum coverage and patient reach. We are continuing to work with Australian laboratories and the Federal Government to ensure locations of greatest need are prioritised and people at the highest risk of COVID-19 have access to these tests.

These are extraordinary times and our teams have been working day and night across the globe to ensure the new cobas® SARS-CoV-2 Test is developed and made available in affected countries as quickly as possible.

Locally, Roche has changed our warehouse and supply chain operations to ensure no time is wasted. All orders for SARS-CoV-2 tests are currently on ‘urgent delivery’ and we are delivering as many tests as possible for Australians, within the limits of supply. Globally, we are going to the limits of our production capacity to make sure large quantities of tests are available for countries most in need. Appropriate testing is absolutely key during this uncertain time. It’s important to followregarding the specific circumstances in which individuals should be tested for the SARS-CoV-2 virus, in order to effectively manage demands for testing.
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