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Cylex's Immune Function Test, ImmuKnow(R), Identifies Optimal Immune Status For Post-Transplant Therapy

October 22, 2017

Cylex Incorporated, a life sciences company and leader in immune function testing, today announced study results on the effectiveness of ImmuKnow(R) in minimizing the risk of infection and rejection in post-transplant patients. Testing with ImmuKnow enables doctors to tailor immunosuppressant drug regimens to prevent organ rejection while avoiding infection.

ImmuKnow is the first and only FDA-cleared blood test to measure the vitality of a patient's immune system. The test uses a single drop of blood and has been adopted as a standard of care at many centers throughout the U.S.

Results of the study (a meta-analysis of original clinical observations) will be published in the September 15th issue of Transplantation, the premier professional journal for transplant physicians. The issue will be available to subscribers on September 12 at transplantjournal.

The Transplantation article concludes that the Cylex ImmuKnow assay provides "an independent measure of the strength or weakness of a patient's immune system. By providing a standardized and objective measure of a patient's immune response, the ImmuKnow assay can guide therapy decisions to better individualize and minimize immunosuppressant regimens such that a patient's risk for complications is greatly reduced."

Judith Britz, Ph.D., Chairman and CEO of Cylex, said "This study defines three measurable immunological response zones: strong, weak and the 'target' zone associated with minimal risk of clinical complications. These zones can guide physicians in the administration and management of immunosuppressant drugs in transplant recipients allowing them to better manage patients to stability," she added.

The meta-analysis was based on independent clinical and therapeutic data on 504 patients who received heart, kidney, kidney-pancreas, liver and small- bowel transplants at one of 8 major transplant centers. The participating transplant centers included:

1. Transplantation Branch, NIDDK/NIH/DHHS, Bethesda, MD;
2. Nazih Zuhdi Transplant Institute / Integris Health, Oklahoma City, OK;
3. Johns Hopkins Medical Institute in Baltimore, MD;
4. Starzl Transplant Institute, University of Pittsburgh, Pittsburgh, PA;
5. Lifelink Foundation, Tampa, FL
6. University of Texas Medical Branch in Galveston, TX
7. University of California in Los Angeles, CA
8. INOVA, Fairfax, VA;

At these centers, ImmuKnow was used to measure immune function in the context of other clinical information. ImmuKnow also measured the risk of infection and rejection in strong, weak and "ideal" immunological response zones. These results were based on measures of adenosine triphosphate (ATP), a key biomarker of immune function and the energy source of cells.

Results indicate that a recipient with a weak immune response value of 25 ng/ml ATP was 12 times more likely to develop an infection than a recipient with a stronger immune response. Similarly, a recipient with an immune response of 700 ng/ml ATP was 30 times more likely to reject the transplanted organ.

The intersection of odds ratio curves in the accompanying figure marks the point (280 ng/ml ATP) of lowest risk for infection and rejection. This ATP measure serves as the "target" level of immune function for solid organ recipients. At this target level, ImmuKnow demonstrated a negative predictive value (NPV) of greater than 96 percent, which suggests that a patient would have a 96-percent chance of avoiding infection or organ rejection. The red line represents rejection risk. The blue line represents infection risk.

"The findings of this meta-analysis provide important evidence that ImmuKnow is a global immune monitoring test that not only improves transplant patient outcomes, but also reduces costs," said Dr. Anthony Sebastian, head of liver transplantation surgery at Integris Baptist Medical Center in Oklahoma, a highly successful program with the best survival rates for liver transplant recipients in the country. "For patients taking multiple immunosuppressive drugs, ImmuKnow reveals the net state of the immune system, and helps physicians reduce the use of immunosuppressive drugs, lowering drug therapy expenses while reducing the morbidity associated with liver biopsies; such biopsies are taken when patients face the possibility of infection or rejection post-transplant."

Dr. Britz added: "These findings demonstrate ImmuKnow's effectiveness in the very challenging area of transplantation where minimizing the dosing of immunosuppressive drugs remains a therapeutic goal. The findings also strongly suggest that ImmuKnow can serve as an effective diagnostic tool in the management of other diseases such as HIV, HCV, cancer and autoimmune disorders where immunosuppression is induced by viruses, drugs, or disease."

About Cylex Incorporated

Cylex is a life science company and a leader in the development and manufacture of unique products that use the immune system for predicting and managing human health. It is the first and only company to offer a patent- protected, FDA-cleared cellular assay of immune system function, ImmuKnow(R), which measures the vitality of a patient's immune system from a single drop of blood. This test enables physicians to better manage and personalize the treatment of life-threatening diseases, such as HIV, HCV, cancer and autoimmune disorders, as well as solid organ and bone marrow transplantation.

ImmuKnow(R) is the only standardized cellular assay, easily performed in the lab, with quick and accurate results. By optimizing therapy, ImmuKnow(R) helps the physician lower the cost of treatment and improve treatment outcome, reduce the side effects of drugs, and enhance the patient's prospects for long-term quality of life.

For further information, visit cylex.

About Transplantation Journal

Transplantation is the official journal of the Transplantation Society. It is the most cited and influential journal in the field (with over 20,000 citations a year). Transplantation is published twice monthly and provides extensive coverage of the most important advances in transplantation.

Transplantation is consistently ranked among the top journals in Transplantation, Surgery and Immunology (Journal Citation Reports), the journal covers areas including: cell therapy and islet transplantation; clinical transplantation; experimental transplantation; immunobiology and genomics; and xenotransplantation.

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