FDA News

FDA approves Pleximmune to predict risk for transplant rejection

The FDA recently approved a blood test used in predicting risk for transplant rejection in patients aged younger than 21 years who undergo liver or small bowel transplantation.

Using a small blood sample from the transplant patient, Pleximmune (Plexision) combines lymphocytes from the donor and recipient to stimulate a response in the recipient’s T-cytotoxic memory (TcM) cells. Pleximmune then measures the number of TcM cells from the transplant recipient that produce CD154 against nondonor human TcM cells. The final numeric score, or Immunoreactivity Index, indicates an increased or decreased risk for transplant rejection.

The test is intended for use in combination with other clinical information when managing anti-rejection therapy among patients with liver or small bowel transplants aged younger than 21 years.

There are no contraindications for Pleximmune, according to the FDA.

The FDA recently approved a blood test used in predicting risk for transplant rejection in patients aged younger than 21 years who undergo liver or small bowel transplantation.

Using a small blood sample from the transplant patient, Pleximmune (Plexision) combines lymphocytes from the donor and recipient to stimulate a response in the recipient’s T-cytotoxic memory (TcM) cells. Pleximmune then measures the number of TcM cells from the transplant recipient that produce CD154 against nondonor human TcM cells. The final numeric score, or Immunoreactivity Index, indicates an increased or decreased risk for transplant rejection.

The test is intended for use in combination with other clinical information when managing anti-rejection therapy among patients with liver or small bowel transplants aged younger than 21 years.

There are no contraindications for Pleximmune, according to the FDA.