Tumor Markers Quantified by Novel Technology

Two companies have signed a licensing agreement for a suite of clinical diagnostic assays for breast cancer based on quantitative immunohistochemistry (IHC).

HistoRx, Inc., (Branford, CT, USA) have signed a multiyear licensing agreement for their proprietary AQUA technology and several diagnostic assays with Genoptix, Inc., (Carlsbad, CA, USA).

Genoptix are launching their NexCourse breast cancer (BCa) assay by AQUA technology, which is more reproducible than traditional IHC testing for confidence in determining appropriate therapy. Moreover, the assay minimizes receptor status false-negative results by utilizing an objective, quantified score for protein expression that provides more accurate results. Genoptix obtained exclusive commercial laboratory rights in the US to develop and perform estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) assays using HistoRx's proprietary technology . The novel technology is 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.

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.

Rana K. Gupta, CEO of HistoRx, said, "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. Genoptix has gained the trust of community oncologists and their patients by offering high quality laboratory testing, and HistoRx could not think of a more appropriate inaugural partner for commercialization of these assays.”

Related Links:
HistoRx, Inc.
Genoptix, Inc.