Delfi Diagnostics Adds Reimbursement, Regulatory Leaders to Management Team

BALTIMORE, March 24, 2022 /PRNewswire/ -- Delfi Diagnostics, a pioneering developer of a new class of high-performance, affordable liquid biopsy tests for early cancer detection, added two new leaders to its management team to oversee regulatory, policy, and reimbursement activities as the company advances its products toward commercialization. Michaela Hart has joined as Delfi's Vice President of Regulatory, Quality and Lab Operations, and Paul Sheives has joined as Vice President of Government Relations and Reimbursement.

"Michaela and Paul bring important regulatory and reimbursement leadership to the team we have been building for the last year at Delfi," said Jenn Buechel, Delfi's Chief Operation Officer. "As we advance our clinical programs and prepare to launch our first commercial products, we are fortunate to have such talented and experienced individuals joining us on our mission to make cancer less deadly through widely accessible early detection tests."

Before joining Delfi, Hart was Vice President of Quality Systems and Compliance for Roche Molecular Solutions where she led the teams that aligned the various quality management systems from Roche's Molecular Systems, Tissue Diagnostics, and Sequencing Solutions customer areas. Previously, she served as Vice President of Quality Management and Regulatory Affairs for Roche Sequencing USA, and also as Vice President of Molecular Operations and Quality Assurance for Veracyte.

"I am especially delighted to be joining Delfi where I will be leading the Regulatory, Quality, and Laboratory Operations teams who play a proactive role in helping to bring safe, reliable, high-performing diagnostic tests to market for the people who need them."

Sheives joined Delfi in late 2021 and most recently served as Senior Director of Health Policy and Reimbursement for Roche Diagnostics where he led all health policy efforts and reimbursement strategies across the company's portfolio in the United States. He previously held leadership roles at the American Clinical Laboratory Association (ACLA) and the Biotechnology Innovation Organization (BIO) where he worked with members and stakeholders to drive health policy solutions affecting access to laboratory diagnostic tests.

"I am thrilled by the opportunity to work with a world-class team to bring Delfi's ground-breaking technology to patients in a responsible and clinically meaningful way. The current reimbursement system presents challenges for developers of tools for the early detection of cancer, and it is our responsibility to ensure that patients have access to these critical tools in the fight against cancer, " Sheives said.

Delfi is developing a new class of liquid biopsy tests for early detection based on altered genome-wide fragmentation profiles, also known as "fragmentomes," representing aberrant packaging of DNA in cancer cells. By applying advanced machine learning algorithms, these fragment patterns are detectable at a very low sequencing cost. Delfi is using this technology to develop highly sensitive and specific cancer detection assays intended for wide and cost-effective distribution and adoption.

SOURCE Delfi Diagnostics