Mercy Bioanalytics Adds Chief Scientific Officer and Vice President for Quality & Regulatory Affairs

In full transparency, the following is a press release submitted to SOURCE media through its business wire service.

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NATICK – –Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, today announced that it has added two senior executives as the Company transitions from research to clinical development. Toumy Guettouche, PhD has joined Mercy as the Chief Scientific Officer, and Michael Smith has joined as the company’s first Vice President for Quality, Regulatory, and Clinical Affairs.

“These are critical hires that will enable Mercy to build upon our exciting preliminary clinical data in lung and ovarian cancer, transitioning into formal test development with the same focus on rigor and quality that has characterized our work from the start,” said Mercy CEO, Dawn Mattoon. “Toumy and Michael are exceptional leaders who share a passion for our mission to relieve suffering and save lives globally through the early detection of cancer.”

Toumy most recently served as the Head of Product Development for Scale Biosciences, following scientific leadership roles at Roche and Grail developing diagnostic tests in oncology and women’s health. Earlier in his career, he led the biorepository, NGS, and microarray operations at the Children’s Hospital of Philadelphia, and led research and development at the University of Miami School of Medicine CLIA laboratory. Toumy completed his PhD and postdoctoral work at the University of Miami School of Medicine.

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He will be giving an invited talk on Mercy’s innovative liquid biopsy approach at the Gordon Research Conference on Cancer Nanotechnology being held in Waterville Valley, New Hampshire from June 11 to 16, 2023.

“I have been impressed with Mercy’s novel approach to the early detection of cancer, the quality of the scientific team they have assembled, and their mission-oriented culture,” said Guettouche. “I am thrilled to be joining at this critical juncture as we bring our test portfolio through key verification and validation studies in preparation for commercialization.”

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Michael comes to Mercy most recently from MDC Associates, where he was the Director of Regulatory and Clinical Affairs. Prior to his tenure at MDC, he held leadership roles in several diagnostics companies including ALPCO Diagnostics and Immunetics. He has broad experience in leading and supporting clinical programs and has guided more than 20 diagnostic tests through FDA clearance using both the 510(k) and Pre-Market Approval (PMA) pathways.

“Mercy’s commitment to quality, and to the design and execution of rigorous clinical studies, is a key differentiator. I am excited by the opportunity to partner with the Mercy team and its highly engaged Clinical Advisory Board as we work together to bring our test portfolio through the FDA,” Smith said.

Mercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer.Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy.

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The patented Mercy Halo™ liquid biopsy platform utilizes biomarker co-localization to interrogate highly abundant blood-based extracellular vesicles that carry unique cancer signatures from their parent cells.

The Mercy Halo™ platform is designed to detect Stage I cancer, when it is most treatable, and enhance the quality of life for cancer patients and their families.

Mercy’s initial focus is the early detection of ovarian and lung cancers. Ovarian cancer, the most lethal gynecological cancer, typically goes undetected until it is too late to cure. Lung cancer, the number-one cancer killer, takes more lives than breast, prostate, and colorectal cancers combined.

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