Tropism Assay for HIV Launched
The new SensiTrop II assay was recently launched by Pathway Diagnostics. The tool is intended for use with patients who are HIV positive to determine CCR5 co-receptor tropism status, as described in the press release issued by Pathway.
The new diagnostic test is the second generation of the molecular SensiTrop II assay. The system combines the heteroduplex tracking assay (HTA) technology with the specificity of molecular sequencing. Testing is completed in the Pathway laboratory; samples are received from Delti Diagnostics in Europe and the U.S.
The SensiTrop II is now available across the country through national reference laboratories. The CCR5 compound clinical trials have also integrated the SensiTrop II assay. This new test is the first tropism genotype HIV test that incorporates the specificity of DNA analysis with HTA sensitivity.
Data presented at the 2008 Clinical Virology Symposium compared the new test from Pathway to the Trofile assay from Monogram. Tests were evaluated in a group of 100 samples, provided by Pfizer, from patients who had been treated for HIV. The two tests had comparable results with respect to misclassification. The launch of the Monogram test was already described on HospitalBuyer following its launch last summer.
The test is an accurate, economical, sensitive, and fast method to determine biologic tropism. Co-receptor tropism effects how HIV can infiltrate different cell types through use of cell receptors. The FDA recommends this sort of testing before patients commence CCR5 antagonist therapy.
May 14, 2008 Related topics: Infectious Diseases, Product Launches, Diagnostic