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Pathway Diagnostics Announces Commercial Availability of Second Generation SensiTrop(TM) II Molecular HIV Co-receptor Tropism Assay
Date:5/7/2008

SensiTrop II accurately classifies Dual/Mixed tropic HIV patients with

samples provided by Pfizer.

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 D
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SOURCE Pathway Diagnostics Corporation
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