Zomedica Expands Market Opportunity for the TRUFORMA Point-of-Care Diagnostic Platform by Securing CE Mark
Zomedica has obtained the CE mark for its TRUFORMA diagnostic platform, enabling its entry into the European Economic Area (EEA). This certification confirms compliance with stringent EU safety, health, and environmental standards.
TRUFORMA, a point-of-care diagnostic tool, has been in the US market since 2021, offering veterinarians quick and accurate test results, empowering faster treatment decisions. The platform is now set to address the European veterinary diagnostics market, which is projected to exceed $3.6 billion by 2028.
Key features include quantitative results with reference lab accuracy and proprietary assays like the Cobalamin & Folate multiplex assay. This expansion positions Zomedica to tap into a significant market opportunity.
- Secured CE mark for TRUFORMA, enabling entry into the European market.
- TRUFORMA offers fully quantitative results with reference lab accuracy.
- Proprietary assays available at the point of care for the first time.
- The European veterinary diagnostics market is projected to surpass $3.6 billion by 2028.
- None.
Insights
Securing the CE mark for the TRUFORMA diagnostic platform represents an important step for Zomedica, enabling entry into the European Economic Area (EEA). Given the European veterinary diagnostics market is projected to surpass
However, the European market has its own set of challenges, including diverse regulatory environments and competitive landscapes, which may impact the speed and scale of adoption. Nonetheless, the ability to provide reference lab accuracy results at the point of care can offer a distinct competitive edge. If Zomedica can effectively market and support its platform, it may well establish a strong foothold in Europe.
For retail investors, it's essential to monitor Zomedica's market penetration strategy, any partnerships or collaborations they form and the initial reception of TRUFORMA by European veterinarians. These factors will significantly influence whether Zomedica can translate this regulatory milestone into tangible financial performance.
The TRUFORMA diagnostic platform utilizes Bulk Acoustic Wave (BAW) technology, which is notable for its precision and speed. This is particularly significant in veterinary settings, where rapid and accurate diagnostics can be important for treatment decisions. Offering tests like the Cobalamin & Folate multiplex assay directly at the point of care reduces reliance on external laboratories, streamlining the diagnostic process.
Veterinarians would likely appreciate the ability to obtain lab-grade results quickly, as this could lead to better patient outcomes and increased client satisfaction. However, the platform's success in the EEA will depend on its ease of use, cost-effectiveness and the availability of a comprehensive range of assays that meet the specific needs of European veterinary practices. Given these advantages, the TRUFORMA system may become a preferred choice for many veterinary clinics.
Investors should consider the competitive positioning of TRUFORMA against existing diagnostic tools and the feedback from early adopters in Europe, as these will be important indicators of its potential success and adoption rate.
CE mark enables launch of the TRUFORMA® Diagnostic Platform into the European Union
ANN ARBOR, MI / ACCESSWIRE / June 25, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced it has secured the CE mark for its proprietary point-of-care TRUFORMA Bulk Acoustic Wave (BAW) diagnostic platform. The CE mark signifies compliance with stringent European Union safety, health, and environmental standards, enabling Zomedica to introduce the TRUFORMA diagnostic platform across the European Economic Area (EEA).
"Securing the CE mark certification is a significant milestone for Zomedica," commented Larry Heaton, Zomedica's Chief Executive Officer. "Since the launch of the TRUFORMA system into the US veterinary market in 2021, we have received a growing number of requests for the platform to be available in various international markets, including the European Union. Veterinarians worldwide recognize the potential of having such a powerful diagnostic tool in a compact and easy-to-use package right at the point of care."
Mike Mockler, Senior Product Manager at Zomedica, stated, "The TRUFORMA diagnostic platform offers fully quantitative results with reference lab accuracy right at the point of care in minutes, allowing veterinarians to make treatment decisions faster and with more confidence. The TRUFORMA platform offers proprietary assays, such as our Cobalamin & Folate multiplex assay, which have never before been available at the point of care, empowering veterinarians to provide new levels of care. We are proud to bring this innovative technology to veterinary practices across the EEA."
"This is an exciting time for the TRUFORMA platform. The CE mark demonstrates Zomedica's commitment to providing better patient outcomes domestically and globally," commented Brandon Marino, Senior Director of Global Channels for Zomedica. "We believe the TRUFORMA platform will enable veterinarians worldwide the ability to make decisions sooner and treat patients faster through its one-of-a-kind diagnostic testing capabilities."
The TRUFORMA platform addresses a
To learn more about the TRUFORMA diagnostic platform and its innovative use of BAW technologies, please visit Zomedica's website at zomedica.com/truforma.
About Zomedica
Based in Ann Arbor, Michigan, Zomedica (NYSE American:ZOM) is a veterinary health company creating products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. Zomedica's product portfolio includes innovative diagnostics and medical devices that emphasize patient health and practice health. Zomedica's mission is to provide veterinarians the opportunity to increase productivity and grow revenue while better serving the animals in their care. For more information, visit www.zomedica.com.
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SOURCE: Zomedica Corp.
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