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FDA approves PleximmuneTM for personalized prediction of transplant rejection in children

PITTSBURGH, Sept. 11, 2014 /PRNewswire-iReach/ -- Today the FDA announced approval of PleximmuneTM, a blood test from the Pittsburgh-based biotech company Plexision. This test predicts acute cellular rejection of transplanted livers and intestines in children. PleximmuneTM is a first-in-class test to determine a personalized rejection-risk index using cell-based technology.

Plexision's PK/PD solutions presented at CHI's Immunogenicity Summit in Washington, DC - November 11, 2013.

Plexision’s Pharmacokinetics (PK)/Pharmacodynamics (PD) solutions presented at Cambridge Healthtech Institute’s Immunogenicity Summit in Washington, DC on November 11, 2013.

Pleximmune test to predict liver transplant rejection presented at the Liver meeting in Washington DC - November 3, 2013.

The Pleximmune test is the first blood test of its kind to predict whether acute cellular rejection will occur in children with liver or intestine transplantation. This information can help transplant physicians guide post-transplant care. During a six-year period, over two hundred and eighty blood samples from more than 200 children were tested in two groups. Samples from the first portion of the study period were termed the training set, and those obtained subsequently were termed the validation set.

American Transplant Congress, Seattle | 18–22 May 2013

The American Transplant Congress was held between May 18-22 in Seattle this year. The American Transplant Congress is the premier venue for scientific exchange between the various disciplines uniquely involved in solid organ transplantation.

ESOT Congress, Vienna | Sept 8-11

Results from Plexision’s pharma collaboration to be reported at the European Society for Organ Transplantation Congress, Vienna | September 8-11

Optimizing the effectiveness of a new immnosuppressant requires usage, which is informed by an understanding of individual rejection-risk and response to the drug. This knowledge can facilitate the design of novel regimens based on the new immunosuppressant, and the selection of patients suited for such regimens.

Plexision provides PK/PD services and dose-response modeling as the bases for drug target selection and development of companion diagnostics.

The European Society of Transplantation (ESOT) is a premier organization whose members include healthcare providers involved in the care of transplant patients in Europe and internationally.