Zynaxis Inc. (NASDAQ:ZNXS) announced Monday that it has fileda 510(k) notification with the FDA for marketing clearance ofits Zymmune CD4/CD8 Cell Monitoring System.
Zynaxis of Malvern, Pa., said the Zymmune system can provideboth CD4+ and CD8+ lymphocyte counts in under 35 minuteswithout the need of either specially trained technologists orexpensive, specialized equipment.
CD4+ lymphocytes (CD4 or helper T cells) are selectivelydestroyed in HIV infection. Reduced numbers of these cells areassociated with the clinical progression of AIDS and anincreased susceptibility to life-threatening infections andcancers.
The National Institute for Allergy and Infectious Diseases(NIAID) of the National Institutes of Health recommends thatHIV-positive individuals be monitored from two to four times ayear for CD4 cell levels.
The CD8+ lymphocyte (CD8 or suppresser T cell) count is animportant second parameter, Zynaxis said. Because the CD8 cellcount remains relatively stable during the progression of AIDS,the CD4/CD8 ratio can be used as a tool for helping determinethe reason for a decrease in CD4 levels.
Currently, CD4 levels are commonly measured using flowcytometry methods, which are costly, require highly trainedpersonnel, and provide results that depend on the operator'slevel of expertise. Other alternatives to flow cytometry cantake up to four hours to perform and provide only CD4 results.
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