Thermo Fisher Scientific has launched its One Lambda pre-transplant risk assessment (PTRA) assay at its CLIA laboratory in Fishers, Indiana.
One Lambda is a simple blood test that evaluates the risk of early acute rejection in kidney transplant recipients.
According to Thermo Fisher Scientific, the PTRA assay offers insights that could lead to a more personalised strategy for managing post-transplant immunosuppression.
The PTRA Assay leverages a 29-marker mRNA signature to categorise patients into high- and low-risk groups for early acute rejection.
The scientific solutions provider said that a recent clinical validation study found that patients with high PTRA scores were six times more likely to face early acute rejection compared to those with low-risk scores.
In addition, the assay exhibited greater prognostic accuracy than traditional risk factors like high positive panel-reactive antibodies (PRA) and the number of HLA mismatches, which did not predict early acute rejection effectively.
Thermo Fisher Scientific transplant services director Chris McCloskey said: “Our One Lambda Pre-Transplant Risk Assessment (PTRA) Assay is the first test of its kind to provide a risk score for early acute rejection based on a patient’s unique gene profile prior to transplant.
“Data from this test may help clinicians make more informed decisions about post-transplant management and better balance a patient’s risk of rejection against the adverse effects of over-immunosuppression.”
The One Lambda pre-transplant risk assessment assay was developed and validated by Thermo Fisher One Lambda Laboratories.
As a laboratory-developed test (LDT), it is utilised for clinical purposes by the CLIA-certified laboratory conducting the assay.
The test has not received US Food and Drug Administration (FDA) clearance or approval as an in vitro diagnostic test.
Earlier this month, Thermo Fisher Scientific announced its plans to advance myeloid cancer clinical research and treatment using next-generation sequencing (NGS) technology.
The company is partnering with the National Cancer Institute (NCI), part of the National Institutes of Health, for the myeloMATCH precision medicine umbrella trial. Recently, the scientific solutions provider completed the acquisition of Olink, a provider of next-generation proteomics solutions, for $3.1bn.
