February 1, 2019
Natera Announces Agreement with One Lambda to Co-Distribute Its Kidney Transplant Rejection Test
Agreement Enhances Commercial Presence in Organ Transplant CentersSAN DIEGO, July 31, 2017 /SAN CARLOS, Calif., Feb. 1, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of cell-free DNA, today announced a partnership with Thermo Fisher Scientific's One Lambda brand, a global leader in human leukocyte antigen (HLA) typing and antibody monitoring assays for transplantation, to co-distribute Natera's kidney transplant rejection test in the United States in collaboration with the company's direct sales team.
"Natera's donor-derived cell-free DNA test complements our existing transplant offerings and enables us to provide a more advanced portfolio for monitoring kidney rejection," said Parisa Khosropour, President, Transplant Diagnostics, Thermo Fisher Scientific. "We look forward to offering our customers a test that improves upon currently available options and provides unique performance advantages in detecting T-cell mediated rejection and subclinical acute rejection, both of which may have a more positive impact on patient outcomes."
Natera's organ transplant rejection assay is designed to detect active allograft rejection in patients who have undergone kidney transplantation. The assay works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood, which can spike relative to normal cfDNA when the transplanted organ is injured due to immune rejection. The assay leverages Natera's core single nucleotide polymorphism (SNP)-based massively multiplexed PCR (mmPCR) technology to accurately measure dd-cfDNA levels without the need for donor genotyping, and it has been clinically validated with test performance independent of donor type, rejection type, and clinical presentation. In a recent study published in the Journal of Clinical Medicine, Natera's assay detected acute rejection (AR) with 89% sensitivity and 0.87 area under the curve (AUC).1 This test performance compares favorably to the current standard of care, which is based on serial measurements of serum creatinine; and it compares favorably against competition, which in a 2017 study reported 59% sensitivity and 0.74 AUC.2 The recent study also had two novel, clinically significant findings relative to previously published studies of dd-cfDNA. The Natera dd-cfDNA assay was able to accurately detect TCMR (T-cell mediated rejection), a common and treatable form of active rejection, and subclinical acute rejection.1 No other dd-cfDNA assay has been shown to detect TCMR or validated to detect subclinical AR, which occurs in 20-25% of patients in the first two years post-transplant,3 and which is considered a major driver of graft failure.
One Lambda, a Thermo Fisher Scientific brand, is the global leader in HLA and antibody monitoring assays for transplantation. Known for its commitment to quality, service, and innovation, the company develops and distributes several lines of HLA typing and antibody monitoring tests utilizing serological, molecular, flow, solid phase & NGS technologies. In addition, One Lambda also provides laboratory instrumentation and computer software that are used to simplify and automate testing procedures and final test evaluations. For more information, please visit www.onelambda.com
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the management of diseases worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.