Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, presented an exciting update to the investment community during the 43rd annual J.P. Morgan Healthcare Conference. In addition to announcing its preliminary financial results for the fourth quarter and full year ending December 31, 2024, the company outlined its oncology innovation roadmap. This includes new products and technologies that are designed to revolutionize molecular residual disease (MRD) testing and early cancer detection (ECD).
Steve Chapman, CEO of expressed optimism about the company’s future, stating, “Building on our strong preliminary financial results in 2024, we are poised for an exciting year with multiple potential catalysts. Since launching our oncology business, we have focused on innovating MRD testing to improve outcomes for patients. Today’s announcement extends that commitment with promising new products and technologies in cancer testing.
Natera has made significant progress since entering the oncology space, and the latest developments mark important steps forward. The company’s new product offerings include advanced versions of its flagship Signatera™ MRD assay, a tissue-free MRD assay, and an innovative early cancer detection (ECD) assay based on DNA methylation signatures.
Signatera™ Genome Assay: A Leap Forward in MRD Testing
Natera’s oncology portfolio has long been anchored by its exome-based Signatera assay, which has gained widespread use and been rigorously validated in clinical practice. The assay has proven highly effective in monitoring molecular residual disease in a variety of cancers, offering a powerful tool for tracking treatment response and detecting minimal residual disease.
Now, Natera is taking a major step forward with the launch of the Signatera genome assay. This new version of the assay leverages whole genome sequencing (WGS) to enable bespoke assay design tailored specifically to each patient’s tumor. By using WGS, the Signatera genome assay provides a deeper, more personalized level of analysis compared to the exome-based version, allowing for more precise detection of molecular residual disease at extremely low levels.
The new Signatera genome assay utilizes Natera’s proprietary multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) technology, which enables it to detect tumor DNA down to low single-digit parts per million (PPM). This makes it one of the most sensitive assays available for monitoring circulating tumor DNA (ctDNA), a critical component of MRD testing.
Building on Natera’s leadership in ctDNA analysis, the Signatera genome assay will allow clinicians to detect the presence of residual cancer cells at earlier stages than ever before. This advancement has the potential to dramatically improve the ability to identify relapses in patients who have undergone cancer treatment, paving the way for earlier interventions and better outcomes.
Tissue-Free MRD Assay: A Groundbreaking Innovation in Cancer Monitoring
In addition to the Signatera genome assay, Natera also announced a new tissue-free MRD assay, which represents a breakthrough in the company’s ongoing research in methylation-based technologies. Traditional MRD assays require tumor tissue samples to analyze the cancer’s genetic profile, but Natera’s tissue-free assay can detect MRD without the need for tissue biopsy, which is often invasive and difficult to obtain.
The tissue-free MRD assay relies on the ability to detect specific methylation patterns in cell-free DNA, a promising approach that has shown great potential in the early detection of cancer. This new assay is expected to be launched for colorectal cancer (CRC) in mid-2025, with other cancer types to follow in the future.
Preliminary data for the CRC assay will be presented at the American Society of Clinical Oncology (ASCO) GI Symposium in late January 2025. The presentation will provide important insights into the assay’s sensitivity and specificity, showcasing its potential to transform the landscape of cancer monitoring. The assay’s ability to detect MRD without needing tissue samples is a significant leap forward in making cancer care less invasive and more accessible for patients.
Early Cancer Detection (ECD) Assay: Detecting Cancer Before Symptoms Appear
Natera also introduced its early cancer detection (ECD) assay, which focuses on detecting cancer-specific DNA methylation signatures in patients before they develop clinical symptoms. This technology is particularly exciting as it promises to detect cancers at earlier stages when treatment options are more effective and outcomes are better.
The ECD assay leverages methylation-based markers to identify changes in the DNA that are specific to cancer, allowing for highly sensitive detection even at early stages. This approach is poised to change the way cancer is detected, moving from traditional symptom-based screening to a more proactive, presymptomatic method of identifying cancer in its earliest forms.
Natera’s ECD program has the added advantage of having access to a vast collection of early-stage and presurgical tumor samples, which it uses to develop and refine its assays. One of the key data sets for the ECD assay comes from Natera’s PROCEED-CRC study, which involves detecting colorectal cancer (CRC) at an early stage. Early data from the study shows that the assay can detect stage 1 CRC with 92% sensitivity and 95% overall sensitivity, with a specificity of 91%.
Natera plans to present more detailed data on advanced adenomas (AA) and CRC from the PROCEED-CRC cohort later this year. If these results show continued success, Natera will move forward with an FDA-grade validation study, a critical step toward bringing the ECD assay to market as a clinically validated tool for early cancer detection.
About Natera
Natera is a global leader in cell-free DNA and genetic testing, with a focus on oncology, women’s health, and organ health. The company’s mission is to make personalized genetic testing and diagnostics a standard of care to help detect diseases earlier, intervene more effectively, and ultimately improve health outcomes. Natera’s tests are backed by more than 250 peer-reviewed publications, demonstrating their accuracy and clinical utility.
The company operates ISO 13485-certified and CAP-accredited laboratories in Austin, Texas, and San Carlos, California, where it performs its advanced genetic testing services. With its cutting-edge products in MRD and early cancer detection, Natera is poised to continue leading the way in precision oncology, making a lasting impact on how cancer is detected, monitored, and treated worldwide.
