USFDA CDRH New Device Approval of Pleximmune as lab blood test...

The FDA has recently approved Pleximmune to be marketed.  Pleximmune is a laboratory blood test that aids in the prediction of the risk of a transplant rejection, known as Acute Cellular Rejection (ACR) in patients under 21 years who have undergone liver or small bowel transplants. 

Product Name: Pleximmune
HDE Applicant: Plexision Inc.
Address: 4424 Penn Avenue, Suite 202, Medical Building, Pittsburgh, PA 15224, USA Approval Date: April 26, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/H130004a.pdf

What is it? Pleximmune is a laboratory blood test that aids in the prediction of the risk of a transplant rejection, known as Acute Cellular Rejection (ACR) in patients under 21 years who have undergone liver or small bowel transplants. 

How does it work?  

• A small sample of the patient’s blood, obtained on the day of their clinical visit, is sent to Plexision’s laboratory for analysis.
• Specific white blood cells (lymphocytes) from the donor and from the transplant patient are combined to stimulate a specific type of response in the patient’s T-cytotoxic memory cells (TcM cells).
• This response is measured by the number of transplant recipient TcM cells that produce the specific substance, CD154, and is measured against non-donor human TcM cells.
• The test’s final numeric score, called the ‘Immunoreactivity Index’ (IR) may indicate an increased or decreased risk of transplant rejection.

When is it used?  

This test result is used in combination with other clinical information to manage anti-rejection therapy in patients under 21 years who have undergone liver or small bowel transplantation.

For detailed information on the Pleximmune Device Approval CLICK HERE