Natera Announces New Study Highlighting the Benefits of Signatera’s Unique Method of Quantifying ctDNA
- MTM/mL was shown to be a more accurate measure of ctDNA than mVAF, particularly for patients undergoing active therapy
- MTM/mL was found to be more predictive of therapy response than mVAF, with a hazard ratio nearly 2x higher
- The study analyzed ctDNA data generated in 55,183 ctDNA-positive samples from 23,543 patients, providing a robust dataset for analysis
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Insights
The findings from Natera's study on circulating tumor DNA (ctDNA) quantification methods present significant implications for the field of oncology, particularly in the application of molecular residual disease (MRD) testing. The research highlights a comparison between mean tumor molecules per milliliter (MTM/mL) and mean variant allele frequency (mVAF) as metrics for assessing ctDNA levels in patients undergoing cancer therapy.
MTM/mL has demonstrated a higher predictive value for therapy response compared to mVAF, especially in stage IV cancer patients receiving immunotherapy. This is evidenced by the nearly doubled hazard ratio (HR) associated with MTM/mL. The HR is a statistical measure used in survival analysis to compare the risk of a certain event occurring between two groups over time; in this context, it measures the likelihood of therapy response. A higher HR suggests a stronger association between the ctDNA dynamics and patient outcomes.
For investors and stakeholders in the biotechnology sector, these results could signify a potential competitive advantage for Natera's Signatera MRD test. The ability to provide a more accurate assessment of treatment efficacy could lead to increased adoption of Signatera in clinical settings, potentially impacting Natera's market share and revenue growth.
The oncological community continuously seeks advancements in diagnostic and monitoring tools to improve patient management. The study under discussion introduces a more accurate measure for ctDNA, which is crucial for determining a patient's disease burden and predicting treatment response. MTM/mL's advantage over mVAF lies in its consideration of total cfDNA and plasma volume, offering a more holistic view of the tumor's presence in the bloodstream.
From a clinical perspective, the utilization of MTM/mL could translate into better-informed decisions regarding patient care, potentially leading to more personalized treatment plans and improved outcomes. However, it is important to recognize that the adoption of new diagnostic metrics must be accompanied by thorough clinical validation and integration into existing treatment protocols.
The biotechnology industry is highly sensitive to innovations that promise to enhance diagnostic accuracy and patient care. Natera's study contributes to this innovative landscape by positioning Signatera's use of MTM/mL as a superior metric for monitoring ctDNA. Market dynamics in the precision oncology space could shift if MTM/mL becomes the new standard for MRD testing, influencing the competitive strategies of other companies in the sector.
Long-term, the adoption of MTM/mL could lead to broader implications for the industry, such as influencing drug development pipelines, shaping regulatory standards and affecting reimbursement policies. The potential for improved therapy monitoring could also drive partnerships between diagnostic firms and pharmaceutical companies, aiming to tailor therapies based on real-time MRD data.
Pan-cancer study showed MTM/mL dynamics were more predictive of therapy response than mVAF dynamics, with an observed hazard ratio nearly 2x higher
To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood. Unlike mVAF, which is a fraction that can be confounded by changes in total background cfDNA, MTM/mL takes into account total cfDNA as well as plasma volume. The premise is that MTM/mL is therefore more representative of a patient’s true disease burden, a hypothesis that was validated in this study.
The study analyzed ctDNA data generated in 55,183 ctDNA-positive samples from 23,543 patients who underwent testing with Signatera for various cancer diagnoses, and it reported the correlation between MTM/mL and mVAF, as well as the correlations of each with patient outcomes.
Key findings include:
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Among the 18,426 patients with longitudinal ctDNA measurements,
13.3% had discordant ctDNA trajectories (increase/decrease) when calculated using MTM/mL versus mVAF. - In patients with stage IV disease receiving immunotherapy (N=51), ctDNA dynamics measured in MTM/mL were more predictive of therapy response than those measured in mVAF, with a hazard ratio (HR) nearly 2x higher (MTM/mL HR 16, p<0.0001; mVAF HR 8.8, p<0.0001).
- In a case study of a patient with metastatic triple-negative breast cancer, disease progression during systemic therapy was reflected in increasing MTM/mL values, while mVAF levels remained stable.
“We are pleased to see the publication of these important findings, in which MTM/mL provided a more accurate measure of ctDNA than mVAF, particularly for patients undergoing active therapy which can impact the levels of background cfDNA,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “Clinicians need tools to enable reliable predictions of therapy response and clinical outcomes. As the only MRD test that uses MTM/mL, this study supports the utility of Signatera for ctDNA quantification, to measure treatment response at critical time points and inform decisions on how patients are managed.”
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231221683887/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
What did the pan-cancer study by Natera, Inc. (NASDAQ: NTRA) reveal about MTM/mL and mVAF dynamics?
How many ctDNA-positive samples were analyzed in the study conducted by Natera, Inc. (NASDAQ: NTRA)?
What did the study conclude about the utility of Signatera for ctDNA quantification?
