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Pathway release second generation molecular HIV co-receptor tropism assay

Pathway Diagnostics : 08 May, 2008  (New Product)
Pathway Diagnostics announces nationwide availability of its patented second generation molecular SensiTrop 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 II Assay in its CLIA-certified laboratory on samples received from national reference laboratories in the USA and Delphic Diagnostics in Europe.

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

SensiTrop II is available nationwide in the USA through national reference laboratories and is also being utilised in CCR5 compound clinical trials. 'Pathway is pleased to introduce its second generation molecular HIV tropism Assay nationwide, providing clinicians a fast (less than seven days), accurate, sensitive and economical testing alternative to the currently available biological HIV tropism assay,' said Walter Narajowski, Pathway Diagnostics president and chief executive officer. 'We are especially pleased with improvements in sample amplification that enable SensiTrop II to provide results from more than 95 percent 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 PhD, vice president of research and development at Pathway Diagnostics.
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