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Personal Genome Diagnostics and PathGroup Enter Co-Development Agreement to Accelerate the Availability of Comprehensive Genomic Profiling with TMB

January 7, 2019

BALTIMORE--(BUSINESS WIRE)--Jan 7, 2019--Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, and PathGroup, a premier provider of anatomic, clinical and molecular laboratory services, announced today that they have entered into a co-development agreement for the PGDx elio™ tissue complete assay. This collaboration brings together PGDx’s scientific, development and regulatory expertise with PathGroup’s substantial experience incorporating clinical Next Generation Sequencing (NGS) into patient care pathways, marking an important step forward in bringing a comprehensive genomic panel through regulatory approval. PGDx and PathGroup share a common vision on the value of a regulated, comprehensive NGS tissue panel that can assist physicians with specific, actionable information to enable improved treatment decisions.

The PGDx elio™ tissue complete panel is a 507-gene test for somatic alterations that detects single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden (TMB). The use of TMB and MSI for the identification of cancer patients whose tumors may be likely to respond to immune checkpoint inhibitor therapy has recently been investigated in clinical trials (TMB) and approved (MSI) by the U.S. Food and Drug Administration (FDA).

“We are extremely pleased to enter into this partnership with PathGroup,” said Doug Ward, Chief Executive Officer at PGDx. “PGDx is developing a portfolio of regulated tissue-based and liquid biopsy products for laboratories worldwide that can provide oncologists and patients with information to better understand the patient’s cancer and make critical treatment decisions. PathGroup is a leader in providing high quality diagnostic services; their commitment to this partnership is a meaningful testament to the value of the PGDx vision, to empower the fight against cancer through localized, standardized NGS testing.”

Under the agreement, the companies will work together on the necessary studies to support and secure regulatory approval for the PGDx elio tissue complete assay. Once available, PathGroup intends to be the first laboratory in the U.S. to utilize the PGDx elio tissue complete assay, empowering oncologists with this new and innovative genomic oncology technology.

“PathGroup is always seeking to expand and enhance the comprehensive genomic information we provide to oncologists and patients to better inform critical treatment decisions,” said Ben Davis MD, Chief Executive Officer at PathGroup. “We look forward to leveraging our collective resources to bring new, innovative testing solutions for cancer diagnosis and therapy. We believe this partnership will offer physicians and patients new horizons for advanced diagnostic content beyond what is currently available, significantly advance our offering for genomic oncology services and, ultimately, improve patient care.”

About Personal Genome Diagnostics Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. For additional information, visit www.PersonalGenome.com.

About PathGroup Founded in 1965, PathGroup has evolved into a premier provider of anatomic, clinical and molecular pathology laboratory services. PathGroup works seamlessly with hospitals and physicians to provide superior diagnostic services---a vital link in the cycle of patient relationships. PathGroup uses the latest proprietary and industry standard technology to deliver timely, accurate laboratory results. The company provides client with the highest quality of services available, consistently exceeding the expectations of physicians, employees, payers and most importantly, patients. One Lab; Total Service. PathGroup is owned by PPC Partners along with management. For more information, visit www.pathgroup.com.

About PPC Partners PPC Partners acquires and operates North America-based, middle-market companies with leading positions in the manufactured products, services and healthcare sectors. Led by Tony Pritzker and the former investment and operating professionals of Pritzker Group Private Capital, the firm’s differentiated, long-duration capital base allows for efficient decision-making, broad flexibility with transaction structure and investment horizon, and alignment with all stakeholders. PPC Partners builds businesses for the long-term and is an ideal partner for entrepreneur and family-owned companies. For more information, visit PPCPartners.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190107005144/en/

CONTACT: PGDx Corporate:

Megan Bailey

Vice President, Marketing

520-820-8710

mbailey@pgdx.com

W2O Group:

Peter Duckler

Director, Media

773-343-3068

pduckler@w2ogroup.com

PathGroup Corporate:

Richard A Halstead

EVP, Chief Commercial Officer

615-234-3915

rhalstead@pathgroup.com

KEYWORD: UNITED STATES NORTH AMERICA MARYLAND

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY GENETICS ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Personal Genome Diagnostics Inc.

Copyright Business Wire 2019.

PUB: 01/07/2019 08:00 AM/DISC: 01/07/2019 08:01 AM

http://www.businesswire.com/news/home/20190107005144/en

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