ViraDx™ Receives Interim Order Authorization from Health Canada

SARASOTA, Fla. (28 June 2022): 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 ViraDx™, a three-in-one COVID-19/Flu A/Flu B rapid antigen test for use by healthcare professionals.

With the physical symptoms of COVID-19 and influenza being nearly identical, the 15-minute ViraDx test is ideal for quickly evaluating patients and helping to guide treatment decisions during the initial office visit. Influenza remains the most common seasonal respiratory virus in Canada and resulting in 12,346 influenza tests performed during the week of 18 June 2022 according to Health Canada’s respiratory virus detection report. In parallel, there have been more than 62.5 million total COVID-19 tests performed during the pandemic with a daily percentage positive value of 9.3% as reported for the week of 24 June 2022.

“With a single sample, ViraDx provides three simultaneous test results—giving clinicians in outpatient care settings the ability to differentiate these viruses and providing a higher level of confidence as they consider the appropriate antiviral treatment options,” said Doug Ward, CEO of Lumos Diagnostics. “With the addition of ViraDx to our portfolio, frontline healthcare providers in Canada can now differentiate bacterial from viral respiratory infections using FebriDx®, and in the case of a viral infection, quickly test for COVID-19 and influenza, which are the two most common respiratory viruses today.”

FebriDx®, ViraDx™ and CoviDx™ are manufactured in the U.S. and made available to healthcare professionals in Canada exclusively through Lumos Diagnostics and its Canadian distributors.

About ViraDx

The 15-minute ViraDx COVID-19/Flu A/Flu B rapid antigen test uses an anterior nasal or nasopharyngeal swab sample to simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B—quickly giving healthcare providers results. ViraDx is packaged as a test kit with individually packaged reagents to allow for increased test distribution. The qualitative results are visually read, easy to interpret, and require no additional instruments, equipment, or special storage, which makes the ViraDx test a practical solution for virtually any healthcare setting.

Compared to polymerase chain reaction (PCR) tests, which are generally more time consuming, more expensive, and require specialized equipment, ViraDx demonstrated diagnostic performance for each of the three simultaneous tests that rival PCR performance.

ViraDx performs as follows:

COVID-19: Sensitivity 93.4%; Specificity 100%

Flu A: Sensitivity 91.4%; Specificity 95.7%

Flu B: Sensitivity 87.6%; Specificity 95.9%

Visit our website at LumosDiagnostics.com for full product details, instructions for use, and availability.

 

 

About Lumos Diagnostics

Lumos Diagnostics specializes 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 customized assay development and manufacturing services for POC tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded POC tests that target infectious and inflammatory diseases.

For more information visit lumosdiagnostics.com or email [email protected]

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.

Media Contact:

Jennifer Christiansen

jennifer.christiansen[email protected]

+1 920 784 3153

Investor Relations Contact:

Matthijs Smith

[email protected]

+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

SEE ALSO
June 21, 2022

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Ward to lead U.S. FebriDx launch pending FDA 510(k) clearance

Reach out to Lumos today to understand how we can deliver you a customized point-of-care diagnostic solution.