CombiMatrix Corp has announced that the validation study performed by its wholly owned subsidiary, Combimatrix Molecular Diagnostics (CMDX), in collaboration with the Department of Pathology at the University of Texas Health Science Center in San Antonio, Tex  is available as an advance online publication in the official journal of the United States and Canadian Academy of Pathology (USCAP), Modern Pathology. 

The online abstract can be reviewed online

HerScan™ is an array based test that is designed to provide an accurate and objective enumeration of the Her2 gene locus against the template of the whole genome.  Moreover, because the copy number status of the Her2 gene, as well as that of a comprehensive representation of the whole cancer genome is contextualized by individual chromosomes, the HerScan™ test facilitates subtyping of breast cancers into the five different subtypes that are cytogenetically characteristic: Luminal A, Luminal B, Her2, Basal-Like and Complex unclassified.

Consequently, for the first time in a single test, the HerScan™ test provides insights into the genomic architecture, and hence etiology and prognosis of the breast cancer, which may be combined with anatomic pathology to facilitate the most appropriate therapeutic regimes for each individual patient. 

Dr Mansoor Mohammed, President and CEO of CMDX noted, “In the current study, our scientists at CMDX and collaborators at UTHSCSA led by Dr. I-Tien Yeh were able to demonstrate that traditional conclusions pertaining to the multiplicity, or copy number, of chromosome 17 may be incorrect.  Because chromosome 17 enumeration is used as the basis for interpreting Her2 gene amplification in a majority of breast cancer cases, our findings are particularly ground-breaking and clinically relevant.  I remain very proud of our team at CMDX and their ability to join between strong commercialization successes and equally impressive academic accomplishments,” concluded Dr. Mohammed.

“With the acceptance of our current HerScan™ test data to Modern Pathology, and the several publications that have also recently been accepted for our HemeScan test, the academic and clinical legitimacy of our cancer array portfolio is established,” stated Dr. Shelly Gunn, Medical Director of CMDX and senior author on the Modern Pathology publication. 

“As a pathologist myself, what impresses me most about our cancer array portfolio is the fundamental ease with which it can be incorporated into existing anatomic pathology reports and the transparency with which the data derived from our tests can be evaluated and assessed.  I firmly believe that the latter characteristics distinguish our tests and that many patients will benefit from the comprehensive nature of our cancer test portfolio as it expands into the clinical arena.”

Dr. Amit Kumar, President and CEO of CombiMatrix Corporation stated, “As we continue to develop, launch, and validate our tests, the oncology market will become a major focus and opportunity for us.  While we have tests available for developmental genetic analysis, during the next few months we will be leveraging our first to market status and strong publication record of our cancer array tests to refocus our efforts on oncology.  Such a redirection of resources will also include additional effort on our non-invasive screen for cancer.”