There has been a lot of talk at the ESC Congress about sustainable cardiology and meaningful innovations. How does your product fit into this conversation?
There are a couple of key issues in emergency medicine today, where chest pain patients are coming into overcrowded emergency rooms, experiencing long waits and are not getting the timely care they require. Because of the need to transport samples to the lab, current in-house lab methods are time consuming, with test results often not available for an hour or more. However, healthcare institutions have historically been hesitant to adopt POC testing due to concerns about its performance. With new testing guidelines, existing point-of-care platforms in use by hospitals are simply not good enough. Their use can lead to too many healthy patients being admitted, or too many sick patients mistakenly being sent home. Our state of the art troponin test is guideline compliant, which makes it better than the vast majority of existing central laboratory platforms. The Meritas POC Analyzer and the cTnI test deliver results within 15 minutes, right at the patient’s bedside..
What is the competitive advantage of your product and what are the benefits for patients and physicians?
This fast turnaround time is paramount to improved decision-making and rapid intervention in the emergency room. We are the only POC Troponin assay to meet the new heart attack diagnosis guidelines, which places us in a unique position. Our innovative technology allows for exceptional flow control at every point, resulting in unprecedented test precision and sensitivity within the shortest possible timeframe. This leads to better patient outcomes and patient satisfaction, improves waiting times, reduces costs associated with needless additional testing, and because of the combined power of the device precision/sensitivity, allows for faster patient disposition algorithms and decisions.
What is your target market?
We obtained the CE mark for our high sensitivity Troponin I product in January 2014 and for our BNP product just this August. We are currently performing clinical trials for our FDA submissions. We expect this to be completed early next year. The Meritas is perfectly suited for emergency rooms and some primary care settings. The products will be made available worldwide.
Dealing with patient data comes with responsibility. How do you handle issues of data transmission and security?
Each specific healthcare facility has its own data protection protocols and firewall. Our data transmission happens securely via Ethernet cable. The cloud is not used in the current process. At no point does our company store patient data. Data is collected and remains within the institution at all times.
What is your company’s vision, and do you integrate the opinions of clinical thought leaders and hospital management experts into the company goals?Yes, they are vital to success in today’s evolving healthcare environment. At Trinity Biotech we strive to provide an all-encompassing turnkey solution to medicine’s toughest and most critical issues with our diagnostic tools, software and cutting-edge technology, which in turn enables our customers to better manage their patients and be leaders in their field. In collaboration with many of the world’s top clinical thought leaders, we have already won CE marking for our first and second Meritas tests; Troponin, for diagnosing heart attacks and BNP, for diagnosing heart failure. Beyond that, we have begun working on the next generation analyzer and are in the process of developing additional tests for pulmonary embolism, D-dimer, along with other tests for a host of other critical conditions. We are solely focused on delivering high value critical tests for the fast-paced emergency room. - See more at: https://healthmanagement.org/c/healthmanagement/issuearticle/technology-update-meritas-poc-analyzer-best-decision-at-poc1?mercury_frame=true&_=1415635467891#sthash.R50jmg7W.dpuf