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HistoRx Announces First Clinical Diagnostic Use Of AQUA® Technology

BRANFORD, Conn., Nov. 12, 2010 /PRNewswire/ -- HistoRx, Inc. (privately held), a diagnostics company, announced the launch and first commercial sale this week of clinical diagnostic assays based on AQUA® technology.  Genoptix, Inc. (Nasdaq: GXDX), a specialized laboratory service provider, is launching NexCourse®(1) BCa by AQUA technology, a suite of breast cancer assays based on quantitative immunohistochemistry.  NexCourse BCa by AQUA technology is:

  • More reproducible than traditional IHC testing, for confidence in determining appropriate therapy
  • Minimizes receptor status false-negative results by utilizing an objective, quantified score for protein expression that provides more accurate results; and
  • Ideal for confirmatory testing of ER/PR/HER2 status prior to hormonal therapy, antibody-based therapy and/or chemotherapy when initial results are inconclusive or negative.

Genoptix and HistoRx signed a multi-year licensing agreement for AQUA® technology and several diagnostic assays based on it in February 2010; the first commercial use announced today triggers a key milestone payment outlined in the agreement.  Genoptix obtained exclusive commercial laboratory rights in the United States to develop and perform estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) assays using HistoRx's proprietary technology.  Misclassification of receptor status by IHC is common:  several studies have shown that false-positive and false-negative ER/PR/HER2 results occur regularly in laboratories around the country and around the world.  Inaccurate results may affect treatment decisions, excluding patients from use of potentially efficacious therapies or inappropriately subjecting patients to therapies known to cause serious adverse events.

"HistoRx is delighted to announce the first availability of AQUA® technology for clinical diagnostics, and pleased that the breast cancer community will be the immediate beneficiaries of the quantification and reproducibility of measurement inherent in NexCourse BCa by AQUA technology," said Rana K. Gupta, CEO of HistoRx.  "Genoptix has gained the trust of community oncologists and their patients by offering high quality laboratory testing, and HistoRx couldn't think of a more appropriate inaugural partner for commercialization of these assays."

"Peer-reviewed literature shows that conventional IHC-based technology can misclassify ER/PR/HER2 receptor status," said Mike Nerenberg, Senior Vice President and Chief Technology Officer at Genoptix.  "AQUA technology is noted for its reproducible quantitation of protein biomarkers in tissue, and can therefore give oncologists confidence when determining the appropriate therapy for their breast cancer patients."

AQUA technology quantifies tumor markers in designated areas of interest, an important component of the assessment of solid tumors for individual cancer patients.

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