ResearchDx and Menarini Silicon Biosystems Launch DEPArray HER2 for Breast and GEA Cancers

Novel tissue-based assay digitally isolates pure tumor cell populations for robust assessment of HER2 gene status with single-cell precision

Irvine, CA-October 2, 2017-ResearchDx, the leading biopharma companion diagnostics provider and Menarini Silicon Biosystems, worldwide manufacturer of image-based cell sorting products and services, jointly announce the launch of DEPArray HER2. The fluorescence in situ hybridization (FISH)-based assay has been validated as a clinical research laboratory developed test (LDT) and is performed by PacificDx, a CAP/CLIA certified and wholly owned subsidiary laboratory of ResearchDx.

Close to 300,000 breast and gastroesophageal adenocarcinoma (GEA) tumors are diagnosed each year in the United States. An estimated 20% of those tumors harbor HER2 gene amplifications. Accurate assessment of HER2 status in breast and GEA cancers is critical for identifying patients predicted to respond to anti-HER2 targeted therapies. Traditional tissue-based assessment of HER2 gene status can be problematic due the mixture of tumor and stromal (normal) tissue in a standard biopsy sample. Compounding the problem of tissue heterogeneity is the known intra-tumor genetic heterogeneity of many breast and GEA cancers such that only a small percentage of the tumor contains HER2 gene amplification.

The DEPArray HER2 test leverages cell isolation capabilities of DEPArray™ NxT technology allowing isolation of pure tumor cell populations from heterogeneous tumor/normal tissue samples. The HER2 test is performed on pure tumor populations isolated from stained cell suspensions digitally sorted using the DEPArray NxT, thus eliminating tissue heterogeneity and allowing true genetic heterogeneity to be revealed more accurately.

“We are the first clinical laboratory to offer HER2 gene testing on pure cell populations isolated from tumor tissue by DEPArray NxT technology,” said Shelly Gunn MD, PhD. ResearchDx’s Chief Medical Officer and Medical Director of the PacificDx clinical laboratory. “We are looking forward to validating additional applications for DEPArray NxT technology including isolation of circulating tumor cells (CTCs) for liquid biopsy applications in a variety of solid tumors.”

“We are excited to see the launch our first DEPArray NxT-based clinical test in the U.S. Notably, this will provide physicians, and most importantly their patients, access to a solution in overcoming unresolved/equivocal HER2 status observed with tissue biopsies“ said Farideh Bischoff, PhD. Menarini Silicon Biosystems, Inc. Chief Clinical Development Officer.

The DEPArray HER2 test has a 5-7 day turn around time and can be performed in our CAP/CLIA certified laboratory on any archival tumor tissue sample. For more information about the test, please visit: www.pacificdx.com.

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