AUSTIN, Texas, May 28, 2021 / PRNewswire / – Natera, Inc. (NASDAQ: NTRA), a pioneer and world leader in cell-free DNA testing (cfDNA), today announced that it has been sued by Guardant Health, in an effort to prevent Natera from exposing the true performance of Guardant’s tests Reveal ™ and the Differences Between Tumors – Informed and tumor naïve molecular residual disease (MRD) assays.
Natera filed a lawsuit against Guardant in U.S. District Court for the Western District of Texas, (File # 6: 21-cv-00540), alleging that Guardant used false and misleading statements to mislead physicians about the performance capabilities of his MRD test, in violation of Lanham Law. Guardant’s MRD assay performance claims are incomplete or unsupported by clinical evidence and may be misinterpreted by physicians and patients.
Natera’s complaint alleges that Guardant engaged in:
- Misleading promotions of 91% sensitivity in surveillance, although this analysis excluded 7 false negatives without clinical justification (24% of all recurrence events). The specificity of the test was also not assessed in this setting, as longitudinal and surveillance samples were not analyzed in patients who remained relapse-free. It is inappropriate to claim the sensitivity of the test without assessing specificity in the same population. The only valid sensitivity statement for Guardant’s MRD assay uses serial longitudinal samples and is 69%.1 compared to 88-93% of Signatera ™2-4 sensitivity.
- Misleading promotions including emails to physicians and a presentation at the recent JP Morgan Healthcare conference that inappropriately equates a 91% sensitivity claim with a mismatched 100% specificity claim. It is very misleading to associate the sensitivity of one assay with the specificity of a different assay. It is also inappropriate for Guardant to claim 100% specificity without specifying that this analysis excluded 2 false positive cases for which a full year of clinical follow-up information was not collected, despite the time required to do so. . This commercial promotion significantly distorts the results of the study and puts patients at risk.
- Misleading promotions of its test for use in Stage II-III CRC, using performance claims derived from a study that does not match the intended use population. 19% of the patients included in the Guardant study had stage IV disease. Patients in the study had an overall recurrence rate greater than 35%, which does not correspond to the stage II-III intended use population.1 No performance breakdown was provided for patients with stage II-III RCC. In addition, many patients in the study received neoadjuvant therapy, making them less eligible for adjuvant therapy. Additionally, test performance has not been reported from the post-surgical time point, which is the time point required for adjuvant chemotherapy decision making.
- Misleading promotions of peak performance, although Guardant declined to report several unfavorable metrics from its study that are critical in assessing differences between MRD testing methods. For example, its pre-surgical detection rate was only 47% in patients who had not received neoadjuvant treatment,1 compared to the Signatera Tumor Informed Test with reported pre-surgical detection rates of 89-94%.2-4 In addition, Reveal’s diagnostic time to detect recurrence was approximately 4 months.1 vs 8.7 months2 for Signatera, which is a difference of 2x.
Natera is committed to a free and open dialogue about data that has a direct impact on clinical decision-making and patient safety. We look forward to working with the medical and academic community to advance the science of MRD testing, in a transparent manner.
Natera is a pioneer and a world leader in cell-free DNA testing from a simple blood test. The company’s mission is to change the management of disease around the world with a focus on women’s health, oncology and organ health. Natera operates ISO 13485 certified and CAP accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to educate obstetricians, transplanters, oncologists and cancer researchers, including biopharmaceutical companies and genetics labs, through its cloud-based software platform. For more information visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical fact contained in this press release are forward-looking statements and do not constitute a representation that Natera’s plans, estimates or expectations will be realized. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update any forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties which may cause actual results to differ materially, including with respect to the evolution of matters that are the subject of litigation or litigation, our efforts to develop and commercialize new or other studies will support the use of our product offerings, or our expectations for the reliability, accuracy and performance of our tests. Other risks and uncertainties are discussed in more detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes from time to time with the SEC. . These documents are available on https://investor.natera.com and www.sec.gov.
Investor Relations: Mike Brophy, Chief Financial Officer, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]
- Parikh A, van Seventter EE, Siravegna G et al. Minimal detection of residual disease using plasma-only circulating tumor DNA in patients with colorectal cancer. Clinical cancer research. 2021. DOI: 10.1158 / 1078-0432.CCR-21-0410
- Reinert T, Henriksen TV, Christensen E et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stage I to III colorectal cancer. JAMA Oncol. 2019; 5 (8): 1124-1131.
- Yukami H, Nakamura Y, Watanabe J et al. Minimal residual disease by analysis of circulating tumor DNA for colorectal cancer patients undergoing radical surgery: an initial report from CIRCULATE-Japan. ASCO 2021 (virtual conference), Abstract 3608, June 4-8, 2021.
- https://www.prnewswire.com/news-releases/natera-to-present-clinical-data-from-largest-prospective-mrd-guided-trial-in-colorectal-cancer-at-the-2021-asco- annual-meeting-301295640.html
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SOURCE Natera, Inc.