ViroGates announces CE-IVD approval for suPARnostic® TurbiLatex on the Roche Diagnostics cobas® Pure and Pro instrument platforms
COMPANY ANNOUNCEMENT - No. 02-2023 – Inside Information - 6 February 2023
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 that it has completed the development and regulatory approval (CE-IVD in Europe) of its suPARnostic® TurbiLatex product for the Roche instrument series cobas® Pure and cobas® Pro. The instruments are the two most recent from the global market leader Roche Diagnostics.
The systems are different in size and have throughput ranges of approximately 500 and 1000 per hour respectively. They are supposed to cover immunochemistry analysis in the mid- to large-volume segments for Roche Diagnostics. Both systems are fully automated requiring no manual handling from the blood sampling until results are processed and are already being installed in various hospitals.
The approval of suPARnostic® TurbiLatex for the Roche Pure® and Pro® systems complements the previous approvals for the other Roche systems cobas® 6000 and 8000 series, as well as product series from other instrument providers such as Abbott, Siemens Healthineers and Beckman Coulter.
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 add another two instrument platforms to our approvals for our flagship product series suPARnostic® TurbiLatex. We are consistently working to stay at the forefront with respect to instrument platforms so hospital customers can run our suPARnostic® analysis irrespective of the instrument line they have chosen. The cobas® Pure and Pro approvals are an excellent example of this as they have been launched recently and we have already managed to validate our products for both instruments.”
The announcement can be found at https://www.virogates.com/investor/announcements
For further information, please contact:
CEO, Jakob Knudsen
Tel. (+45) 2226 1355, email: [email protected]
Västra Hamnen Corporate Finance
Tel. (+46) 40 200 250, email: [email protected]
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 the Netherlands, 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 850 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, the Abbott Labs Architect™ and Alinity™ instruments and the Beckmann Coulter AU 5800 instrument. ViroGates works with partners to develop solutions for other platforms.
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.
- Jakob Knudsen, CEO, +45 2226 1355, [email protected]