Pathway Diagnostics Announces Commercial Availability of Second Generation SensiTrop(TM) II Molecular HIV Co-receptor Tropism Assay

MALIBU, Calif., May. 07 /PRNewswire/ --

MALIBU, Calif., May 7 /PRNewswire/ -- Pathway Diagnostics announces nationwide availability of its patented second generation molecular SensiTrop(TM) II assay, combining the sensitivity of molecular heteroduplex tracking assay (HTA) technology with the specificity of molecular sequencing for determining the co-receptor tropism status of HIV infected patients. Pathway performs the SensiTrop(TM) II assay in its CLIA-certified laboratory on samples received from national reference laboratories in the U.S. and Delphic Diagnostics in Europe.

On April 28th Pathway presented data during the 2008 Clinical Virology Symposium comparing SensiTrop II with Monogram's Trofile(TM) assay. The performance of SensiTrop II was examined using 100 HIV treatment experienced patient samples provided by Pfizer and previously tested by the Trofile(TM) assay. SensiTrop II classified 41 samples as Dual/Mixed (D/M) tropic, 9 of these samples were classified as R5-tropic by Trofile. Maraviroc's phase III data stated Trofile misclassified 7-9% of patients as CCR5, similar to the results obtained in the present study.

SensiTrop II is available nationwide through national reference laboratories and is also being utilized in CCR5 compound clinical trials. "Pathway is pleased to introduce its second generation molecular HIV tropism assay nationwide, providing clinicians a fast (less than 7 days), accurate, sensitive and economical testing alternative to the currently available biological HIV tropism assay," said Walter Narajowski, Pathway Diagnostics President and CEO. "We are especially pleased with improvements in sample amplification that enable SensiTrop II to provide results from more than 95% of samples received."

SensiTrop II is the first HIV genotype co-receptor tropism test that combines the sensitivity of HTA and the specificity of DNA sequence analysis. "We are excited by the outcome of this study, and that our combined molecular approach demonstrates excellent concordance with the Trofile assay on the samples provided by Pfizer," said Terry Robins Ph.D., Vice President of Research and Development at Pathway Diagnostics.

About HIV Co-receptor tropism

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.

About Pathway Diagnostics

Pathway Diagnostics Corporation provides biomarker development and laboratory testing services for pharmaceutical company's drug development programs. 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 leading to future companion diagnostics.