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Pathway Diagnostics Announces Patent Issuance for the Diagnostic Measurement of HIV Tropism for the Initiation or Modification of HIV Therapy

HIV tropism status needed to initiate therapy with Pfizer's recently

approved Selzentry(TM) (Maraviroc), CCR5 antagonist

MALIBU, Calif., Nov. 15 /PRNewswire/ -- Pathway Diagnostics announces that the U.S. Patent & Trademark Office (USPTO) has issued U.S. Patent number 7,294,458 (the '458 patent) entitled "Analysis of HIV-1 Co-receptor Use in the Clinical Care of HIV-1-Infected Patients." Pathway Diagnostics has licensed the '458 patent (with rights to sub-license) from Health Research Incorporated (HRI), Rensselaer, NY for use in the fields of laboratory diagnosis and monitoring. The '458 patent discloses and claims diagnostic methods for monitoring CCR5 and CXCR4 co-receptor use in the treatment of human immunodeficiency virus (HIV) infection. The '458 patent also claims monitoring CXCR4-specific strain suppression in HIV-positive individuals undergoing highly active anti-retroviral therapy (HAART). Pathway has also obtained licensing rights from HRI for related patent applications, that together with the '458 patent, form the technical foundation of Pathway's SensiTrop HIV tropism assay.

"The patented technology underlying Pathway's SensiTrop assay is a significant innovation that enables HIV treating physicians to select the appropriate treatment for patients using a proprietary molecular assay that is fast and affordable. Pathway's partners have recognized the strength of Pathway's patent portfolio and the importance of these patents when testing CCR5 and CXCR4 co-receptor use for HIV therapy," stated Walter Narajowski, CEO of Pathway Diagnostics.

About HIV Co-receptor tropism and the SensiTrop(TM) assay

The ability of the HIV virus to infect different cell types utilizing different cell surface receptors is referred to as HIV co-receptor tropism. One type of HIV that utilizes the CCR5 co-receptor has been shown to be blocked by CCR5 antagonist drugs such as Selzentry. A different type of HIV that utilizes the CXCR4 co-receptor is not blocked by CCR5 antagonists. Therefore, determining the tropism status of HIV-infected patients has been indicated by the FDA before initiating CCR5 antagonist therapy.

Pathway's SensiTrop(TM) assay is a proprietary application of molecular hybridization based on heteroduplex tracking technology developed by Dr. Barbara Weiser and Dr. Harold Burger's laboratory at the Wadsworth Center, New York State Department of Health, Albany NY. Heteroduplex tracking technology interrogates the complete HIV V3 loop, detecting sequence differences that determine whether the patient's HIV utilizes either the CXCR4 or CCR5 co-receptor. SensiTrop, like other molecular based assays, is highly sensitive and rapid to perform.

About Pathway Diagnostics

Pathway Diagnostics Corporation focuses on the development, validation and commercialization of novel, proprietary biomarker assays across multiple disease areas that address unmet medical needs and improve patient care. The company combines assay development expertise with a broad range of advanced technology platforms, a fully licensed CLIA laboratory, and a growing portfolio of patent-protected biomarkers for pharmaceutical companies to use in drug development and for commercial reference laboratories and in vitro diagnostic manufacturers to license for use in patient testing. Pathway effectively bridges the gap between biomarker research and biomarker commercialization, as well as ensures a regulatory-compliant environment for laboratory testing for preclinical and clinical drug development programs.

SOURCE Pathway Diagnostics
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