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Veteran Regulatory Expert Maria Chan Joins Personal Genome Diagnostics



11/29/2016 10:55:59 AM

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BALTIMORE, Nov. 29, 2016 /PRNewswire/ -- Personal Genome Diagnostics Inc. (PGDx), a leading provider of advanced cancer genome testing products and services, today announced that Maria Chan, PhD, has joined the company as Vice President of Regulatory Strategy. Dr. Chan will play a major role in shaping regulatory strategy at PGDx and will oversee all regulatory activities.

Personal Genome Diagnostics, Inc.

"We are thrilled to have an individual with the regulatory expertise and deep insights of Maria Chan heading our regulatory efforts," said Doug Ward, Chief Executive Officer of Personal Genome Diagnostics. "Dr. Chan combines a strong science background, hands-on experience as a Food and Drug Administration (FDA) reviewer and a successful tenure as a FDA diagnostics division director during a period of technological and regulatory change. We look forward to her guidance in navigating the evolving global in vitro diagnostics regulatory environment as we continue to expand our portfolio of advanced cancer genomic tests." 

Dr. Chan noted, "PGDx is a pioneer with a foundational commitment to scientific leadership in the field of cancer genomic testing. I welcome the opportunity to work with the exceptional PGDx team to develop and refine our regulatory strategies as we add in vitro diagnostic tests to our growing menu of laboratory-based assays designed to facilitate the use of precision medicine and improve patient outcomes."

Dr. Chan was the FDA Division Director, Division of Immunology & Hematology Devices at the Center for Devices & Radiological Health, Office of In Vitro Diagnostics & Radiological Health, where she headed four branches including Immunology, Hematology, Pathology and Genetics. Earlier in her career at the FDA, Dr. Chan was promoted from Scientific Reviewer of immunology, genetics and molecular diagnostic devices to Team Leader and then Associate Division Director for the Immunology Branch. Prior to the FDA, Dr, Chan was Director of Immunology and Director of Technical Services in the Department of Laboratory Medicine at the Children's National Health System. During this period she was also Associate Professor, Departments of Pediatrics and Pathology at the George Washington University Medical Center. Early in her career, Dr. Chan was Associate Director of the Immunogenetics Laboratory and an Assistant Professor in the Division of Medical Genetics at the Johns Hopkins University School of Medicine. Dr. Chan received a BA degree from the University of Oregon and a PhD in Immunology from the State University of New York at Buffalo. She completed post-doctoral training in Immunogenetics at Johns Hopkins.

PGDx offers a complete range of cancer genome analysis tools, including exome and targeted approaches for tissue specimens, targeted approaches for plasma samples and a variety of custom tissue and plasma-based options designed to address the specific research needs of cancer researchers and drug developers. It was established in 2010 by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. Under the leadership of founders Drs. Luis Diaz and Victor Velculescu, the company has achieved consistent growth by successfully commercializing novel clinical and investigational products and services for researchers, drug developers, molecular testing laboratories and physicians and patients. PGDx's service offerings for researchers and testing labs are complemented by the clinical services it provides through its CLIA-certified laboratory. 

About Personal Genome Diagnostics
Personal Genome Diagnostics (PGDx) advances the frontiers of cancer medicine through innovative genomic technologies for oncology researchers, drug developers, clinicians and patients. The expert team at PGDx draws on a deep understanding of cancer biology, extensive experience in cancer genomics and clinical oncology, and the company's distinctive technologies. These novel technologies precisely identify and characterize unique genomic alterations in tumors. PGDx is working toward broad patient access to its genomic approaches, through a CLIA-certified facility providing comprehensive genomic services, as well as its PROGENEUSTM technology transfer solution and in vitro diagnostic products to enable other molecular laboratories to easily internalize testing. For additional information, visit personalgenome.com.

Contacts


PGDx Corporate: 

Media:

Melody Gretz

Barbara Lindheim

973 598-5515

BLL Partners LLC                                 

mgretz@personalgenome.com                        

212 584-2276                                   


blindheim@bllbiopartners.com

Logo - http://photos.prnewswire.com/prnh/20150112/168424LOGO

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/veteran-regulatory-expert-maria-chan-joins-personal-genome-diagnostics-300369530.html

SOURCE Personal Genome Diagnostics Inc.


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