Lumos Diagnostics Receives Authorization for CoviDx™ SARS-CoV-2 Rapid Antigen Test in Canada

The CoviDx test from Lumos Diagnostics gives qualified healthcare providers in Canada qualitative, easy-to-interpret results within 15-20 minutes in cases of suspected COVID-19 and when performing serial testing of asymptomatic patients. Visit lumosdiagnostics.com to learn more. (Photo: Business Wire)

MELBOURNE, Australia--()--Lumos Diagnostics (ASX: LDX), a leader in rapid point-of-care (POC) diagnostic technologies, today announced that Health Canada has granted Interim Order authorization for the Lumos CoviDx™ SARS-CoV-2 Rapid Antigen Test. The CoviDx test gives qualified healthcare providers qualitative, easy-to-interpret results within 15-20 minutes in cases of suspected COVID-19 and when performing serial testing of asymptomatic patients.

“As SARS-CoV-2 continues to evolve, rapid point-of-care testing is a critical component of the Canadian public health response,” said Rob Sambursky, MD, President and Chief Executive Officer of Lumos Diagnostics. “Using CoviDx as part of routine testing and triage protocols can help advance public health and safety in Canada, while also supporting the important efforts underway to ensure the continuity of commerce, tourism and education across the country.”

CoviDx is authorized by Health Canada for use by qualified healthcare professionals in evaluating symptomatic patients, and for serial testing of patients without symptoms. The CoviDx test is a stand-alone POC test that uses individual pre-filled extraction reagent vials to make it easy to administer in any patient care setting – without any additional instruments or equipment. The test is compatible with both nasopharyngeal and the less invasive nasal swab sample collection and provides a simple “yes/no” result.

With Health Canada’s Interim Order authorization, CoviDx is available to qualified healthcare providers across the country through Lumos’ distribution partners.

This announcement has been approved by the Lumos Disclosure Committee.

About Lumos Diagnostics

Lumos Diagnostics specialises in rapid, cost-effective, and complete point-of-care (POC) diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos offers customised assay development and manufacturing services for POC tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercialises novel Lumos-branded POC tests that target infectious and inflammatory diseases.

For more information about Lumos Diagnostics and the CoviDx SARS-CoV-2 rapid antigen test, visit lumosdiagnostics.com.

Forward-Looking Statements

This announcement contains forward-looking statements, including references to forecasts. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions, and other important factors, many of which are beyond Lumos' control and speak only as of the date of this announcement. Readers are cautioned not to place undue reliance on forward-looking statements.

Contacts

Media Contacts (U.S. and Global):
Jennifer Christiansen – Lumos Diagnostics
jennifer.christiansen@lumosdiagnostics.com
+1 920 784 3153

Media Contact (Australia):
Haley Chartres – H^CK
haley@hck.digital
+61 423 139 163

Investor Contact:
Matthijs Smith
ir@lumosdiagnostics.com
+61 411 137 080
+61 3 9087 1598

Company Registered Office:
Lumos Diagnostics Holdings Ltd
Level 4, 100 Albert Rd
South Melbourne, VIC 3205
+61 3 9087 1598

Release Summary

Health Canada has granted Interim Order authorization for CoviDx – a rapid antigen test to help healthcare providers confirm the presence of COVID-19.

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Contacts

Media Contacts (U.S. and Global):
Jennifer Christiansen – Lumos Diagnostics
jennifer.christiansen@lumosdiagnostics.com
+1 920 784 3153

Media Contact (Australia):
Haley Chartres – H^CK
haley@hck.digital
+61 423 139 163

Investor Contact:
Matthijs Smith
ir@lumosdiagnostics.com
+61 411 137 080
+61 3 9087 1598

Company Registered Office:
Lumos Diagnostics Holdings Ltd
Level 4, 100 Albert Rd
South Melbourne, VIC 3205
+61 3 9087 1598