First Cellular Assay for Immune System Health

The assay has been cleared by the U.S. Food and Drug Administration (FDA).

Called ImmuKnow, the assay was recently presented at the annual meeting of the American Association for Clinical Chemistry (AACC) in Los Angles (CA, USA) in July 2004. The assay was developed by Cylex Inc. (Columbia, MD, USA), which states it the first and only FDA-cleared cellular assay for the immune system.

¡°As useful as HIV-1 viral load and CD4 have been in monitoring AIDS patients, it is clear that these measurements of immune status can often conflict with each other,¡± remarked Dr. Belinda Yen-Lieberman, Ph.D., director of the Cleveland Clinic Immunology Laboratory (OH, USA). ¡°By measuring immune function further, we can better explain why patients with adequate CD4 numbers still experience viral load breakthrough. Very simply, their CD4 cells are functionally incompetent, and we can now assess that with Cylex¡¯s ImmuKnow technology.¡±

The assay was also introduced to key transplant surgeons at a special symposium during the annual meeting of the American Transplant Congress in Boston (ATC, MA, USA). ¡°Managing the HCV-infected transplant patient is especially confounding, since clinical manifestation of infection and rejection are often the same,¡± commented Harlan Wright, M.D., of the Integris Baptist Medical Center (Oklahoma City, OK, USA). ¡°ImmuKnow offers the first opportunity for doctors to distinguish infection from rejection, which is obviously so vital to clarifying therapeutic strategies for the patient.¡±

¡°Case studies, such as those reported at the AACC and ATC meetings, reaffirm the value of ImmuKnow in enabling physicians to better manage and individualize the treatment of life-threatening diseases and serious conditions such as transplantation in a highly cost-effective way,¡± summarized Judith Britz, Ph.D., chairman and CEO of Cylex.




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