TriPath Imaging Inc is releasing two new molecular diagnostic products for cancers of the cervix and breast to leading experts who will evaluate analytical performance and initial clinical feasibility. These molecular diagnostic products are being released in a Research Use Only (RUO) format to facilitate the initiation of external research studies that will augment internal studies that are currently in progress, a company release said.
"We believe that the release of these innovative new products to leading experts is a major catalytic event for TriPath Imaging," stated Paul R. Sohmer, chairman, president and CEO of TriPath Imaging. "The release of these products to leading medical experts reflects a significant milestone in our commitment to develop and commercialize solutions to redefine the early detection and clinical management of cancers of the cervix and breast," he added.
The external research study goals include analytical performance evaluation, assessment of clinical feasibility and an independent verification of the assay by academic and clinical centres of excellence. It is anticipated that the results of these external research studies will be submitted for presentation and publication, enabling laboratories and medical experts to assess the analytical performance and future potential of these RUO reagents.
For cervical cancer research, the test will be available initially to leading academic institutions, including Johns Hopkins University School of Medicine, Massachusetts General Hospital and University of Colorado Health Sciences Centre. For breast cancer staging research, TriPath Imaging is finalizing arrangements to make the test available to one or more top researchers in the field. Additional or alternate researchers will be selected based on expertise and availability.
Johnny D. Powers, senior vice president and general manager of TriPath Oncology elaborated, "We are very pleased to be working with these outstanding academic centres that not only understand the current clinical problems in cervical disease screening but also understand the importance of molecular tests that can help address these unmet needs. We believe these studies will provide independent confirmation of our analytical performance in a real-world clinical setting, and will serve as the basis for early scientific abstracts and publications."
The SurePath ImmunoCytoChemical test is being developed to aid in the identification of high-grade cervical disease and, as appropriate, to triage patients to further diagnostic and treatment procedures. This test builds on TriPath Imaging's existing cervical cancer technologies. The test reagents will incorporate a proprietary formulation of protein-based biomarkers that will be applied to a slide prepared from a cervical cytology sample collected using TriPath Imaging's proprietary SurePath test pack. The Company has initiated discussions with the US FDA regarding the design of a clinical trial that could support an application for Pre-Market Approval (PMA).
From a global perspective, cervical cancer is the third most common cancer in women, with 370,000 new cases identified annually worldwide.