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SeQure Dx emerges from stealth mode to fulfill the promise of on-target gene editing therapies for biopharma partners, physicians, and patients

Building on Dr. J. Keith Joung’s ONE-seq platform, SeQure Dx has developed a portfolio of assays and data solutions to find, assess, and manage off-target risks from discovery to clinical development to patient impact.

SeQure Dx, a cutting-edge gene editing diagnostics company, has announced its emergence from stealth mode with an aim to partner with biopharma companies developing gene editing therapeutics.  The company is armed with technology discovered and developed by the Joung Lab at Massachusetts General Hospital and Harvard Medical School and funding from a $17.5M Series A raised in 2021.  SeQure Dx’s platform comprises the only scalable, population-based and editing technology-agnostic in vitro off-target evaluation method complemented by orthogonal methods required for off-target risk validation.

“I am very excited for SeQure Dx to bring the ONE-seq technology to market to support the emerging and dynamic gene editing therapeutics space,” said Dr. Joung,  a co-founder of SeQure Dx and Chair of its Scientific Advisory Board as well as the Robert B. Colvin, M.D. Endowed Chair in Pathology at Mass General Hospital. “Evaluating potential off-target edits created by these therapies plays an enormous role in the advancement of safe and effective gene editing.  It’s crucial to define any potential off-target edits from program discovery to eventual patient treatment, and SeQure Dx’s comprehensive assay and data solutions does this using state-of-the-art methods.”

The last decade since the characterization of CRISPR has seen immense optimism surround the clinical potential of gene editing therapy as well as the emergence of dozens of companies focused on bringing a variety of gene editing approaches into the clinic. Quickly, the optimism was tempered by the discovery that off target editing is a companion effect for all the gene editing methods conceived so far. The ever-looming potential off target effects drove a critical need to identify and characterize these impacts to advance.

The FDA has confirmed its off-target concern with the March 2022 release of draft guidance highlighting the need for comprehensive off-target evaluation, placing an emphasis on frequency, as well as potential off-target types and site location.  As part of this guidance, the FDA recommends using off-target risk assessment methods that provide sufficient sensitivity along with multiple cell donor analyses to ensure a higher confidence level.  SeQure Dx’s proprietary technologies, under license from MGH, position the company to be the gold standard in demonstrating therapeutic safety throughout research, development, and commercialization, meeting the FDA’s standard proclaimed in the draft guidance.

The company’s core mission is to leverage its cutting-edge platform to partner with biopharma in a way that allows the gene editing developers to solely focus on the advancement of their programs and outsource the entirety of the off-target evaluation workstream to SeQure Dx.  SeQure Dx’s offerings span the drug development lifecycle, providing value for its partners preclinically, during clinical development and throughout future commercialization via rigorous IND-enabling data package(s), ensuring patient safety from a trial enrollment and follow-up perspective, and clinical decision support and long-term safety monitoring, respectively.

SeQure Dx’s leadership team, founders and scientific advisors comprise industry veterans, diagnostics experts, and some of gene editing’s most prominent leaders, including:

  • Ellen Sheets, MD, MBA; CEO, Director, and co-founder – previously CMO at Qiagen, CEO of CSA Medical and most recently Entrepreneur-in-Residence at Mass General Brigham Ventures
  • Keith Joung, MD, PhD; Founder and Scientific Advisory Board Co-Chair – leading innovator in gene and epigenetic editing, Robert B. Colvin, MD Endowed Chair in Pathology, Pathologist at MGH and Professor of Pathology at Harvard Medical School, co-founded companies such as Beam Therapeutics, Chroma Medicine, Editas Medicine, Nvelop Therapeutics, Pairwise Plants and Verve Therapeutics.
  • John Iafrate, MD, PhD; Scientific Advisory Board Co-Chair – leader in developing diagnostic technologies in genomics and transcriptomics, Deputy Chair of Pathology at MGH, Professor of Pathology at Harvard University, co-founder of as ArcherDx, Boston Lighthouse and Hunter Biodiscovery
  • Martin Aryee, PhD; Co-founder and Scientific Advisory Board member – develops bioinformatics analysis methods and computational tools for genomic assays, Associate Professor in Department of Data Science and Director of Hematologic Malignancies, Biostatistics and Computational Biology at Dana-Farber Cancer Institute, Institute Member of the Broad Institute.
  • Vikram Pattanayak, MD, PhD; Co-founder and Scientific Advisory Board member – develops comprehensive in vitro methods for off-target gene editing nomination, Assistant in Pathology at MGH and Instructor in Pathology at Harvard Medical School.
  • Thomas Mullen, PhD; CSO – diagnostic and genomics veteran, previously at Quest Diagnostics and Broad Institute of MIT and Harvard serving in various leadership roles within the clinical genetics and genomics space
  • John Truesdell, MBA; CBO – medical device and diagnostic leader, previously held various leadership roles at Foundation Medicine and is a US Navy SEAL combat veteran
  • Dan Davis, MBA; CFO – serial CFO for early-stage life science companies, responsible for closing numerous funding rounds and strategic transactions

The company’s Series A investors include RiverVest Venture Partners, Mass General Brigham Ventures, Casdin Capital, Digitalis Ventures, Bold Capital Partners, and Alexandria Venture Investments.

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John Truesdell, Chief Business Officer