At CovarsaDx, we’ve earned a solid reputation in respiratory diagnostics, helping companies like OSANG Healthcare, Nuclein, and Healgen bring their innovations through regulatory clearance.
But we’re not stopping there.
We also have deep experience in cardiovascular clinical research, an area that continues to demand urgent attention. With heart disease holding its place as the leading cause of death worldwide, the push for faster, more accurate diagnostics has never been more important.
Cardiovascular disease claims nearly 18 million lives each year, making up about a third of all global deaths. Even more alarming is that over a third of those are people under 70. In the U.S., heart disease costs the healthcare system more than $250 billion every year and that number’s only going up, with global costs expected to top $1 trillion by 2030.
That’s the reality. The good news is that early diagnosis can change it.
How We Support Your Cardiovascular Trials
Whether you’re evaluating NT-proBNP, cardiac troponin, or another biomarker, our team knows how to design and run trials that reflect real-world clinical settings, especially acute care environments like the emergency department (ED). We’ve supported trials where speed, accuracy, and clinical decision-making matter most.
We understand how cardiovascular diagnostics are used in the moment—by frontline clinicians who rely on POC results to guide treatment. That’s where our background in ED workflows and rapid deployment studies gives our sponsors a critical edge.
What We Bring to the Table
Biomarker and POC Trial Expertise
We’ve worked closely with cardiac biomarkers and understand how to validate them in fast-paced settings. Our trial designs go beyond just performance metrics. We look at how a diagnostic fits into real-world clinical workflows and how it can deliver meaningful value for both clinicians and patients.
Proven Regulatory Strategy
Our regulatory team has deep experience navigating 510(k), De Novo, and PMA pathways for IVDs and point-of-care diagnostics. We work closely with sponsors to develop smart regulatory strategies, align with FDA expectations, and guide submissions every step of the way. Whether it’s a straightforward clearance or a more complex classification, we know how to keep the process moving efficiently.
Strong Clinical Network
One of our biggest advantages is our network of ED physicians and cardiovascular specialists. These relationships help us design practical, feasible studies and makes patient recruitment a lot smoother.
Meet the People Behind the Work
At CovarsaDx, our cardiovascular expertise is backed by a leadership team with deep roots in clinical strategy, regulatory affairs, and operational execution. Here are the folks driving our work in this space:
Chermaen Lindberg
As President and CEO of CovarsaDx, Chermaen brings 20+ years of experience in global clinical development, specializing in IVDs and point-of-care diagnostics. She has led clinical and regulatory strategies for some of the most complex trials in the industry—including respiratory and cardiovascular diagnostics. Chermaen is known for her ability to translate scientific innovation into successful trial outcomes and regulatory approvals, and she’s passionate about bringing impactful diagnostics to market faster.
Marielle Lejcher
As Vice President of Regulatory Affairs and Quality Assurance, Marielle brings more than 20 years of experience guiding diagnostics through complex regulatory landscapes. She has led successful FDA submissions across cardiovascular, infectious disease, and oncology spaces, with a strong command of both U.S. and international requirements. Known for her strategic mindset and collaborative approach, Marielle builds trusted relationships with regulators and crafts submission strategies that are both efficient and effective.
Tim Krauskopf
As Vice President of Clinical Operations, Tim is the driving force behind our clinical execution. He has spent more than 20 years leading trials for diagnostics and medical devices, including studies in fast-paced environments like EDs. Tim thrives on turning complexity into clarity, ensuring trials are well-coordinated, sites are supported, and enrollment stays on track. His solutions-focused leadership is key to delivering high-quality results on time and on budget.
Of course, successful trials take more than just leadership. Our broader team of clinical researchers, project managers, regulatory experts, and quality specialists all play a vital role in bringing diagnostics to life. Meet the rest of the CovarsaDx team.
Your CRO Partner for Cardiovascular Diagnostics
We’re actively growing our footprint in cardiovascular diagnostics and are always looking to partner with companies developing innovative tools for heart health. If you’re working on something new in this space—or even just exploring what it might take to get started—we’d love to talk.
Let’s turn your innovation into better outcomes for patients everywhere.
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