Published study demonstrates Natera's ability to identify heterogeneous cancer mutations in patients with early-stage lung cancer

Natera, Inc., (NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a study published in Annals of Oncology showing that Natera's massively multiplexed PCR (mmPCR) technology, coupled with its proprietary algorithms, can detect both ubiquitous (clonal) and heterogeneous (subclonal) tumor mutation variants in blood samples from patients with early-stage non-small-cell lung cancer (NSCLC).

Of 37 variants found in tumor tissue biopsies from four patients with Stage I and II lung cancer, 16 variants were detected in the blood samples, with at least two detected for each patient. Twenty-five percent of the variants detected in the blood samples were heterogeneous, meaning that they occurred in only part of a tumor. Ninety-four percent of the variants detected in the blood samples were predicted driver mutations, meaning that they were likely to promote tumor growth.

"In this pilot study, Natera's technology helped us demonstrate that both clonal and subclonal tumor mutations are present in the cell-free DNA of patients with early-stage lung cancer" said Charles Swanton, M.D., Ph.D., of the Translational Cancer Therapeutics Laboratory at The Francis Crick Institute in London, and senior author of the paper. "We look forward to expanding our collaboration with Natera as part of the TRACERx study." TRACERx (ClinicalTrials.gov NCT01888601), funded by Cancer Research UK, is a national collaboration between six clinical centers and four centers of scientific expertise in the U.K., and is intended to study tumor heterogeneity in lung cancer patients over time. Natera's technology was selected to provide analysis of cell-free DNA in plasma for the trial.

Natera's non-invasive testing method can assess the overall mutation load in patients with cancer using only a blood sample. This methodology may detect variants in plasma cell-free DNA that, due to the heterogeneous nature of tumors, may not be detected by tissue biopsy. Since subclonal variants are expected to be present at substantially lower tumor fraction in plasma than clonal variants, the ability to detect variants at low concentrations is important in the detection of emerging variants that could affect treatment.

Natera's mmPCR technology and proprietary algorithms were developed in the context of non-invasive prenatal testing (NIPT), which can identify Down syndrome and other chromosomal aneuploidies and microdeletions with high accuracy. Natera has enhanced this underlying technology for the oncology applications, and believes that it has powerful tools for the early identification of cancer and for therapeutic monitoring.