The FDA has signed off on a new blood test that can help predict whether transplanted livers or intestines will be rejected after being implanted in children.
Pittsburgh-based Plexision won regulators' OK under the FDA's Humanitarian Device Exemption program for Pleximmune. The company noted the approval category is reserved for rare disease populations, and that the test fills an unmet need to non-invasively measure the rejection risk in children after a liver or intestine transplant. Plans call for testing samples at the company's CLIA-certified laboratory in Pittsburgh.
"Understanding the developing immune systems of children who receive lifelong anti-rejection medicines after transplantation can be challenging," Plexision CEO Ashok Reddy said in a statement. "We see such challenges of unique patients populations as opportunities for personalized diagnostics."
Plexision said the test generates an overall accuracy that either comes close to or exceeds 80%, in the two-month period following the test. The company established the results after testing blood samples from 200 children who had a liver or intestine transplant. Patients had their procedures at Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center, the company said.
Plexision added that the test advances the standard of care, because the risk of rejection is typically assessed with a variety of clinical data including blood tests, which do not typically produce results that point to rejection. Blood tests on the market today don't always give detailed information about organ function, either, Plexision said.
Other players are also developing better tests to measure transplantation rejection risk. Among them: CareDx, which is pursuing work on a next-generation blood test to monitor heart and kidney transplant patients, and has an existing test for those with heart transplants to assess risk of rejection.
Pleximmune said it uses cell-based technology to determine personalized rejection risk for transplantation, and is also developing diagnostics for immunological disorders and drug development work. According to its web site, Plexision is a subsidiary of India's Sandor Proteomics. The parent company offers cellular and molecular diagnostic tests in Southeast Asia for congenital metabolic disease, plus genome-wide discovery and next-generation sequencing services.
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