PacificDx and Targeted Genomics Announce Release of Hi-Res HER2 Test for Breast Cancer

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Testing Provides Definitive Results for HER2 Equivocal Breast Cancer

Determining the HER2 (ERBB2) gene status in breast tumor tissue is critical for identifying patients predicted to respond to targeted anti-HER2 therapy. Yet, in an estimated 10-20% of the over 200,000 new breast cancers diagnosed each year in the US alone, the HER2 gene status is reported as “equivocal” by traditional pathology testing. HER2 equivocal breast cancer presents a treatment decision dilemma for oncologists, and the clinical necessity for a definitive alternative testing method. Hi-Res HER2 addresses the specific needs of breast cancer patients with high-risk, HER2 equivocal disease.

PacificDx, a CAP/CLIA certified laboratory in Irvine, CA specializing in high-complexity testing, and Targeted Genomics, a healthcare consultancy based in San Antonio, TX, have partnered to bring their expertise to the design and optimization of a DNA-based HER2 gene test, Hi-Res HER2™ for Breast Cancer.

PacificDx is the only laboratory in the United States offering this testing. Oncologists can order Hi-Res HER2 testing through one of PacificDx’s Pathology Laboratory Partners or by contacting PDX at info(at)pacificdx(dot)com.

Drawing from over 10 years’ experience resolving equivocal HER2 breast cancer, the Hi-Res HER2 test was designed by Targeted Genomics and optimized in the PacificDx Laboratory. Using proprietary DNA microarray technology and advanced bioinformatics, the Hi-Res HER2 test definitively determines the patient’s tumor HER2 gene status enabling accurate and timely treatment decisions.

“Pathology and oncology communities recognize the value that unequivocal HER2 testing brings to breast cancer patients. In the age of precision medicine and targeted cancer therapies, it is more important than ever to accurately determine the HER2 gene status for each individual patient’s tumor” said Shelly Gunn MD, PhD, Medical Director of PacificDx Laboratory.

"As the first PacificDx Laboratory Partner, Precision Pathology is pleased to offer this valuable testing service to clinicians so they can make timely and accurate treatment decisions for breast cancer patients with HER2 equivocal disease" said Roby Joyce MD, President and Medical Director of Precision Pathology Services in San Antonio, TX.”

About PacificDx
Recognized as a leader in the design and implementation of high-complexity testing, the PacificDx ( Laboratory provides outsourcing services to pathology groups and biopharma allowing seamless integration of molecular assays into their existing test menus.

About Targeted Genomics
Targeted Genomics, LLC ( is a healthcare consultancy based in San Antonio, TX. The consultancy provides expertise to the medical community and biopharma in the design, coordination, and interpretation of genomic testing for cancer, chronic disease, and wellness.

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Vicki Garcia
Research Dx
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