Molecular Diagnostics for Cancer Released for Evaluation

Two new molecular diagnostic tests for cancers of the cervix and breast have been released for Research Use Only (RUO) to facilitate external studies that will augment internal studies now in progress.

The goals of the external research include analytic performance evaluation, assessment of clinical feasibility, and an independent verification of the assays by academic and clinical centers of excellence. It is expected that the results of the external research will be submitted for presentation and publication, so that laboratories and medical experts can assess the analytic performance and potential of the RUO reagents.

The tests were developed by TriPath Imaging (Burlington, NC, USA). "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,” announced Paul R. Sohmer, M.D., chairman, president, and CEO of TriPath Imaging.

The SurePath ImmunoCytoChemical test is being developed to aid the identification of high-grade cervical cancer and, as appropriate, to triage patients to further diagnostic and treatment procedures. The 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 by using TriPath's proprietary SurePath test pack. TriPath Imaging has initiated discussions with the U.S. Food and Drug Administration (FDA) regarding an application for premarket approval.

The test will initially be available to leading academic institutions, including Johns Hopkins University School of Medicine, Massachusetts General Hospital, and the University of Colorado Health Sciences Center. Cervical cancer is the third most common cancer in women. Incidence rates and resulting deaths have declined in most developed countries where Pap smear screening and treatment have become routine.

"We are very pleased to be working with these outstanding academic centers 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,” said Johnny D. Powers, Ph.D., senior vice president and general manager of TriPath Oncology.

The SureDetect breast cancer markers are being developed to help determine the choice of therapy and in assessing the risk of early relapse, recurrence, and poor clinical outcome in patients suffering from early stage disease. The test incorporates a panel of protein-based biomarkers that produce quantitative results when applied to tissue samples.

For breast cancer staging research, TriPath Imaging is finalizing arrangements to make the test available to one or more top researchers in the field. Based on expertise and availability, additional or alternate researchers will be selected. Breast cancer is the most frequently diagnosed nonskin cancer in women. In 2004, the American Cancer Society estimates that 215,990 new cases of invasive breast cancer will be diagnosed in the United States alone, and more than 40,000 deaths will occur.

Disease management decisions are made by the patient and clinician after consideration of the optimal treatment available for the stage and biologic characteristics of the cancer, the patient's age and preferences, and the risks and benefits associated with each treatment protocol. In line with the growing trend toward individualized medicine, clinicians could use individualized data and molecular testing as part of the overall mosaic of information that enables them to recommend treatment, in addition to historical experiences based on the general population.




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