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2022-05-25 15:43:27

25.5.2022 15:43:25 CEST | ViroGates | Company Announcement

COMPANY ANNOUNCEMENT - No. 12-2022 – Inside information - 25 May 2022

BIRKERØD, DENMARK - ViroGates A/S, a medical technology company developing blood tests for better triaging in hospitals to improve patient care and reduce healthcare costs, today announces the successful CE-IVD accreditation of its novel point-of-care finger prick analysis product for the detection of suPAR.  

The suPARnostic® POC+ product now has full CE-IVD accreditation for use in professional healthcare settings to identify inflammation and immune activation by measuring suPAR. The product will be sold under the brand name suPARnostic® POC+.

The suPARnostic® POC+ development is a collaboration between ViroGates, and Austria based GENSPEED Biotech GmbH and is based on the GENSPEED Technology that allows for quick and fully automated processing of finger-prick blood to help the hospital sector to triage patients better and faster. The analysis takes approximately 20 minutes to conduct.

The product can potentially incorporate more biomarkers into the same panel in the future. ViroGates and GENSPEED attempted to incorporate C-reactive protein (CRP) during the product development phase, but the results were not within the required quality for clinical use.

The plan is to run a comprehensive handling study with a clinical partner to ensure that all product features are adequate in the clinical setting before a full commercial rollout. The commercial rollout is expected to start in Q1 2023 and will not have a financial impact on 2022 results.

CEO Jakob Knudsen says in a comment: “We are excited to come to this important milestone of having finalised the CE-IVD work for our suPARnostic® POC+ product.  The product performs according to pre-defined criteria and has been tested with multiple users during the analytical and clinical validation. We want to make sure that our customers are comfortable with the product, and hence we aim to include even more users before a full commercial rollout. The product will broaden the market for triage using suPAR as a biomarker since many smaller and more rural hospitals can now be engaged in early triage and risk stratification of acute medical patients.”

GENSPEED Biotech GmbH, CEO, Max Sonnleitner says: “The CE-IVD certification of this novel rapid test for suPAR out of a drop of blood is a key milestone in this great collaboration combining an outstanding biomarker with our flexible GENSPEED point of care testing technology. We are looking forward to further exploiting the potential of these joint efforts aiming for the ultimate benefit for customers and patients”

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

For further information, please contact:

ViroGates A/S:

CEO, Jakob Knudsen

Tel. (+45) 2226 1355, email: jk@virogates.com

Certified Advisor:

Västra Hamnen Corporate Finance

Per Lönn

Tel. (+46) 40 200 250, email: per.lonn@vhcorp.se

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, France and Benelux, while distributors serve other markets.

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

About suPAR and suPARnostic®

suPAR is a biomarker detected by ViroGates' suPARnostic® products. It is a protein found in the plasma. suPAR is considered a general risk status biomarker indicating inflammation and can indicate disease presence, severity, and progression across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. Strong scientific evidence from more than 800 clinical trials and studies shows 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 global demands on health systems and tightening healthcare budgets necessitate efficiency improvements and innovative hospital solutions. 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.

About GENSPEED Biotech GmbH and the GENSPEED® Technology

GENSPEED Biotech offers a unique technology platform on which rapid tests can be developed for medical diagnostics and various industrial applications. The technology combines microfluidics, miniaturized opto‐electronics and automation as the proprietary basis of a small, simple, reliable and IVD CE certified test system. The system enables the detection of up to 8 different biomarkers as a multiplex assay on‐site within only a few minutes and with high sensitivity. For more information on GENSPEED Biotech please visit www.genspeed‐biotech.com.

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.