Las Vegas, NV — CovarsaDx, a leading clinical research organization (CRO) focused exclusively on in vitro diagnostics (IVDs) and medical devices, has appointed Mark Boyle as Chief Operations Officer (COO).
Boyle brings more than 25 years of global leadership experience spanning early-stage diagnostics ventures, multinational corporations, and strategic consulting. His track record includes scaling innovative diagnostic technologies from concept through regulatory approval and commercialization, driving significant revenue growth, and leading global teams across regulatory, quality, and clinical functions.
In his role as COO, Boyle oversees operational strategy and execution across CovarsaDx’s clinical, regulatory, and quality services, ensuring scalable infrastructure, disciplined program management, and operational excellence as the company expands into new diagnostic markets.
“Mark’s experience sits at the intersection of strategy and execution,” said Chermaen Lindberg, president and CEO of CovarsaDx. “He has led global portfolios, built high-performing teams, managed complex regulatory pathways, and driven commercialization success in the IVD space. That combination of leadership and operational rigor will be instrumental as we continue to grow.”
Boyle most recently served as Vice President of Global Consulting Services at North American Science Associates (NAMSA), where he led more than 130 MedTech consultants across international operations and was responsible for global service delivery, overall financial performance, and strategic growth initiatives.
Prior to NAMSA, he held executive roles at QIAGEN and Cellestis, where he played a pivotal role in the global expansion of QuantiFERON-TB Gold, helping drive the franchise to more than $100 million in annual sales.
His career also includes leadership roles as President of Clinical Genomics IVD, Chief Business Officer at Ellume USA, and senior advisory positions supporting emerging diagnostic companies through product development, regulatory strategy, market access, and commercialization.
“CovarsaDx has built a strong reputation as a specialized CRO purpose-built for diagnostics,” said Boyle. “I’m excited to be part ofa team that understands the complexity of IVD and medical device development and is committed to delivering strategic, senior-level partnership to sponsors. I’m focused on building the right operational foundation so we can scale thoughtfully and continue giving our clients the structure and expertise they need to bring new technologies to market efficiently.”
Boyle holds a Bachelor of Science in Biochemistry, Microbiology, and Immunology and a Graduate Certificate of Management from The University of Adelaide, Australia.
His appointment reinforces CovarsaDx’s commitment to combining deep scientific expertise with operational leadership to support sponsors across the full product lifecycle.
About CovarsaDx
CovarsaDx is a prominent clinical research organization (CRO) specializing in in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Its team of regulatory, quality and clinical experts have extensive industry experience and consist of regulatory strategists, quality experts, study managers, monitors, data managers and statisticians who work together to deliver reliable clinical results, enabling clients to bring life-saving technologies to market efficiently.
Ready to move your program forward? Reach us at studies@covarsadx.com.