Natera’s success traces to pioneering research isolating and analyzing fetal DNA fragments circulating in a pregnant woman’s bloodstream. Natera capitalized on the emerging space of non-invasive prenatal tests (NIPT) with products such as Panorama that represented a major advance over risky amniocentesis procedures used for definitive diagnosis. Commencing its journey in the NIPT space as the fourth company to enter the U.S. market, Natera swiftly ascended to leading position in test volumes in the 2010s. The proficiency with cfDNA thus achieved positioned Natera advantageously for liquid biopsy-based cancer testing. Natera’s strategic approach initially addressed early detection by focusing on minimal residual disease (MRD) monitoring post-treatment. In 2017, Natera introduced Signatera—a pioneering NGS based ctDNA test designed to identify and trace residual disease following cancer therapy. This innovative test employed patient-optimized assays and boasted impressive sensitivity. Originally introduced solely for research objectives, Signatera was made available as a Laboratory-Developed Test (LDT) for clinical utilization starting in 2019. Preliminary retrospective data underscored its performance capabilities.
Signatera’s analysis is customized to patient-specific clonal cancer mutations, tailored on the basis of unique mutational signature from the tumor tissue. It detects ctDNA at remarkably low levels, identifying mutations at allele frequencies as low as 0.01% in the blood. By tracking ctDNA changes over time, it furnishes insights into treatment efficacy and recurrence risk. Natera witnessed escalating momentum in oncology testing, with a 150 percent YoY increase with over 190,000 tests conducted in 2022. Though women’s health products still drive most of Natera’s revenue, with 20% YoY growth reported in 2022, cancer diagnostics contribute significantly to assay volume upticks, totaling over 2 million tests. Signatera’s personalized and comprehensive approach currently extends across a spectrum of malignancies as well as immunotherapy response monitoring.
Clinical trials such as CIRCULATE, BESPOKE, DARE, and Galaxy— and an expanding body of peer-reviewed publications demonstrate its ability to detect residual disease months ahead of conventional diagnostics, bolstering its robust evidential foundation. Key FDA endorsements, including multiple breakthrough device designations since 2019, and growing Medicare coverage have further cemented its trajectory. Signatera’s roadmap encompasses FDA approval as a companion diagnostic, with PMA submitted in October 2023, and expanded Phase III clinical trials. Natera’s other oncology offerings include the tissue-based Altera for therapy guidance and Empower, a liquid assay for hereditary cancers. Natera’s growth strategy has also involved constructive collaborations with the competition such as the FoundationOneTracker launched in 2023. It integrates insights from FoundationOneCDx, the tissue based comprehensive genomic profiling test from Foundation Medicine with Natera’s customized ctDNA analysis to monitor treatment response, especially with immunotherapies. In an exciting development in 2022, Natera announced strategic expansion into early cancer diagnostics and screening. Building on its demonstrated proficiency in MRD monitoring and with exclusive access to a bank of prospectively collected CRC samples at the Aarhus University, Natera is developing and validating cancer screening products, and is poised to push boundaries in this emerging space.
