ViroGates A/S : announces CE-IVD approval for suPARnostic® TurbiLatex on the Siemens Healthineers Atellica® platform

4.6.2021 12:47:49 CEST | ViroGates | Company Announcement

COMPANY ANNOUNCEMENT - No. 15-2021 - 04 June 2021

BIRKERØD, DENMARK - ViroGates A/S, a medical technology company developing blood tests for better triaging in hospitals to improve patient outcomes and reduce healthcare costs, announces that it has completed the development and regulatory approval (CE-IVD in Europe) of its suPARnostic® TurbiLatex product for the Siemens Healthineers Atellica® platform.

The Atellica® platform is the most recent clinical chemistry and immunoassay system from Siemens Healthineers. The system has particular advantages since maintenance and inspections can be run while the system is operational, and the “down-time” is markedly reduced compared to previous systems. In addition, Atellica® is a fully automated system requiring no manual handling from the blood sampling until results are processed.

The approval of suPARnostic® TurbiLatex for the Atellica® system complements the previous approvals for the Abbott Architect™, Abbott Alinity™, the Roche Diagnostics cobas® systems, and the Siemens Healthineers ADVIA® Chemistry XPT system.

The suPARnostic® Turbilatex product is a pivotal element in ViroGates’ European expansion strategy, focusing on the acute care market.

CEO Jakob Knudsen says in a comment: ”We are excited to be able to offer suPARnostic® TurbiLatex on the Atellica® platform from Siemens Healthineers. We experience that Atellica® is capturing markets share, and we have potential customers who have been waiting to complete the validation for this platform. We look forward to implementing suPARnostic® TurbiLatex at these hospitals to support faster and better patient triage decisions to the benefit of patients, hospitals, and payers.”

The announcement can be found at https://www.virogates.com/investor/announcements 

For further information, please contact:

ViroGates A/S:

CEO, Jakob Knudsen

Tel. [phone], email: [e-mail]

Certified Advisor:

Västra Hamnen Corporate Finance

Per Lönn

Tel. [phone], email: [e-mail]

About ViroGates

ViroGates A/S is an international medical technology company developing and marketing blood test products under the suPARnostic® brand for better triaging in hospitals to improve patient care, reduce healthcare costs and empower clinical staff.

The company was founded in 2000. Headquartered in Denmark, ViroGates’ sales force covers the Nordics, Spain, and France, while distributors serve other markets.

ViroGates’ shares (VIRO) are listed on Nasdaq First North Growth Market Denmark. For more information, please visit www.virogates.com.

About suPAR and suPARnostic®

suPAR is the biomarker detected by ViroGates’ suPARnostic® products and is a protein in plasma, measurable in every human being. suPAR is considered a general risk status biomarker indicating disease presence, disease severity and progression, organ damage and mortality risk across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. Strong scientific evidence from more than 600 clinical trials and studies show that the higher the level of suPAR, the worse the prognosis for the patient.

The suPARnostic® products can be used to support healthcare professionals in making clinical decisions on hospitalization or discharge of acute care patients. The increasing demands on health systems globally and tightening healthcare budgets necessitate efficiency improvements and innovative solutions in hospitals. The use of suPAR in clinical routine in emergency departments can improve patient care and reduce healthcare costs by increasing the number of discharges by up to 34% and reducing the average hospital length-of-stay by up to 6% without affecting mortality. suPARnostic® TurbiLatex is currently available on Roche Diagnostics’ cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments and the Abbott Labs Architect™ and Alinity™ instruments. ViroGates works with partners to develop solutions for other platforms.

Disclosure regulation

Prospects about the future reflect ViroGates' current expectations for future events and results. The statements are by nature inherent in risks, uncertainties and other matters that are difficult to predict or out of control. The actual results may therefore differ from the expectations expressed.

Contacts

• Jakob Knudsen, CEO, [phone], [e-mail]

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