This section highlights FDA-related milestones and regulatory updates for drugs developed by Natera (NTRA).
Over the past two years, Natera has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMvigor011, Latitude™, Prospera, Signatera, and SWOG. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IMvigor011 FDA Regulatory Events
IMvigor011 is a drug developed by Natera for the following indication: in Muscle-Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMvigor011
- Announced Date:
- August 18, 2025
- Indication:
- in Muscle-Invasive Bladder Cancer
Announcement
Natera, Inc. announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The trial is sponsored by Genentech, a member of the Roche Group.
AI Summary
Natera, Inc. today announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). Sponsored by Genentech, the study used the Signatera ctDNA test to detect molecular residual disease (MRD) in the blood after surgery. Around 760 patients were monitored with serial Signatera testing for up to 12 months.
Participants who tested Signatera-positive and had no visible recurrence on imaging were randomized to receive the cancer immunotherapy atezolizumab (Tecentriq®) or a placebo every four weeks for up to one year. The trial showed that Signatera-positive patients treated with atezolizumab had statistically significant and clinically meaningful improvements in disease-free survival and overall survival compared to those on placebo.
Natera plans to finalize its premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic to guide atezolizumab treatment after cystectomy. These results could change how resectable bladder cancer is managed.
Read Announcement- Drug:
- IMvigor011
- Announced Date:
- April 5, 2024
- Indication:
- in Muscle-Invasive Bladder Cancer
Announcement
Natera, Inc announced an analysis from the IMvigor011 study that was presented at the European Association of Urology (EAU) Congress 2024 in Paris, France.
AI Summary
Natera, Inc. presented new findings from the IMvigor011 study at the European Association of Urology (EAU) Congress 2024 in Paris. The study evaluated muscle-invasive bladder cancer (MIBC) patients who remained negative for molecular residual disease (MRD) using Natera’s personalized Signatera test after surgery.
The analysis showed that patients who stayed MRD-negative had remarkable outcomes, with 100% overall survival at 12 months and 98% at 18 months. Disease-free survival rates were also high at 92% and 88% at 12 and 18 months, respectively. These results suggest that patients who consistently test MRD-negative may not need further adjuvant treatment, offering a more personalized approach to post-surgery care. The findings, supported by Genentech, could influence future treatment decisions and potentially improve outcomes for bladder cancer patients.
Read Announcement
Latitude™ FDA Regulatory Events
Latitude™ is a drug developed by Natera for the following indication: For Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Latitude™
- Announced Date:
- July 7, 2025
- Indication:
- For Colorectal Cancer
Announcement
Natera, Inc announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD assay, which were presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI).
AI Summary
Natera, Inc. recently presented data at the 2025 European Society for Medical Oncology GI Congress on its tissue-free Latitude™ MRD assay, a test designed for monitoring colorectal cancer (CRC) patients. The study involved approximately 200 patients and analyzed over 1,300 plasma samples collected from individuals with resectable stage I-IV CRC. The assay demonstrated strong performance, detecting recurrences with a sensitivity of 58% shortly after surgery and 81% during later surveillance, with a median diagnostic lead time of 4.6 months.
Additionally, the test showed high specificity, reaching 92% at the patient level and 97% at the sample level during surveillance. The results highlighted the assay’s prognostic value, as MRD-positive patients had significantly worse outcomes, and its predictive capability for adjuvant chemotherapy benefits among high-risk patients, offering a promising tool when tissue samples are not available.
Read Announcement
Prospera FDA Regulatory Events
Prospera is a drug developed by Natera for the following indication: CfDNA testing.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Prospera
- Announced Date:
- July 24, 2025
- Indication:
- CfDNA testing
Announcement
Natera, Inc. announced that the American Journal of Transplantation published findings from the PEDAL study. PEDAL is the first prospective multi-center trial evaluating longitudinal trends of donor-derived cell-free DNA (dd-cfDNA) to determine the prognostic ability of Prospera in assessing outcomes following kidney transplant rejection.
AI Summary
Natera, Inc. announced that the American Journal of Transplantation published PEDAL study findings. PEDAL is the first prospective, multi-center trial to track donor-derived cell-free DNA (dd-cfDNA) over time to test the Prospera blood test’s ability to forecast outcomes after kidney transplant rejection.
The trial ran at 28 transplant centers in the U.S., enrolling 488 kidney transplant recipients over four years. Among them, 66 patients had biopsy-proven acute rejection and their dd-cfDNA levels were measured with Prospera over eight weeks. Researchers recorded each patient’s health at one year to compare with dd-cfDNA trends.
Results showed patients with low or decreasing dd-cfDNA levels post-rejection had 60 times higher odds of a positive outcome and were 13 times more likely to recover kidney function. Conversely, 97.5% of patients with sustained high dd-cfDNA had poor one-year outcomes. This suggests Prospera can guide doctors in personalized treatment after rejection.
Read Announcement
Signatera FDA Regulatory Timeline and Events
Signatera is a drug developed by Natera for the following indication: MRD Test for cancer therapies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Signatera
- Announced Date:
- January 25, 2025
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study.
AI Summary
Natera, Inc. announced new data from the Phase III CALGB (Alliance) / SWOG 80702 study at ASCO GI 2025. The study used the Signatera test, a personalized circulating tumor DNA assay, to identify stage III colorectal cancer patients who could benefit from an intensified treatment. Approximately 1,000 patients with available post-surgical plasma samples were enrolled in the trial and randomized to receive standard FOLFOX chemotherapy with or without the addition of celecoxib, a common NSAID.
Results from the study showed that patients who tested positive on Signatera experienced significant benefits in both disease-free and overall survival when celecoxib was added. Specifically, the data indicated a marked improvement in survival outcomes compared to those treated with chemotherapy alone. These findings highlight the promising role of personalized medicine in tailoring adjuvant treatment for colorectal cancer patients.
Read Announcement- Drug:
- Signatera
- Announced Date:
- December 12, 2024
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced the enrollment of the first patients in the SAGITTARIUS clinical trial. Sponsored by The AIRC Institute of Molecular Oncology (IFOM-ETS) and funded by the European Union Horizon Europe Programme, SAGITTARIUS is a global, randomized, phase III clinical trial designed to evaluate the use of Signatera to guide personalized adjuvant treatment strategies for patients with colon cancer.
AI Summary
Natera, Inc. has enrolled the first patients in the SAGITTARIUS clinical trial, a global, randomized phase III study designed to evaluate the use of its Signatera test for guiding personalized adjuvant treatment strategies in colon cancer. The trial is sponsored by The AIRC Institute of Molecular Oncology (IFOM-ETS) and is funded by the European Union Horizon Europe Programme.
The study plans to enroll approximately 700-900 patients with stage III and high-risk stage II colon cancer following surgical resection at over 20 sites worldwide. In this trial, patients who test positive with Signatera will be randomized to receive either a therapy tailored to their unique tumor mutational profile or the standard six-month chemotherapy regimen. This approach aims to explore whether personalized, genomically-driven treatment options can improve outcomes and potentially reduce the need for traditional chemotherapy in certain patients.
Read Announcement- Drug:
- Signatera
- Announced Date:
- November 25, 2024
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc. announced that it will present new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 10-13 in San Antonio, TX. Natera and its collaborators will present a total of six abstracts.
AI Summary
Natera, Inc. announced it will present new Signatera™ data at the San Antonio Breast Cancer Symposium (SABCS) held from December 10-13 in San Antonio, Texas. The company, a global leader in cell-free DNA and genetic testing, will showcase six abstracts that highlight recent advancements on Signatera’s role in monitoring breast cancer. These presentations will cover key areas such as a phase III clinical trial evaluating niraparib's effectiveness in improving disease-free survival in patients with triple-negative and HR+ HER2− breast cancers. Other abstracts will discuss the use of circulating tumor DNA (ctDNA) analysis alongside genomic testing to identify actionable mutations and assess patient outcomes. Additionally, several studies will report on patient-reported outcomes, showing that ctDNA testing does not increase anxiety and might help guide treatment decisions. This work reinforces Natera’s commitment to providing effective, personalized cancer care.
Read Announcement- Drug:
- Signatera
- Announced Date:
- September 14, 2024
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced that new data from the GALAXY arm of the ongoing CIRCULATE-Japan trial was released today at the 2024 Congress of the European Society for Medical Oncology (ESMO) in Barcelona, Spain. GALAXY is one of the largest and most comprehensive prospective studies of circulating tumor DNA (ctDNA) testing in resectable colorectal cancer (CRC).
AI Summary
Natera, Inc. announced new data from the GALAXY arm of the ongoing CIRCULATE-Japan trial at the 2024 Congress of the European Society for Medical Oncology in Barcelona, Spain. GALAXY is one of the largest and most comprehensive studies examining circulating tumor DNA (ctDNA) in patients with resectable colorectal cancer. The trial data showed that using the Signatera test, which detects molecular residual disease, can predict overall survival and the benefits of adjuvant chemotherapy. Patients who were ctDNA-negative after surgery had significantly higher survival rates compared to those who were positive. Moreover, the results indicated that Signatera-positive patients who received chemotherapy experienced a 50% reduction in the risk of death. These findings highlight the potential of using ctDNA testing to guide personalized treatment plans, improve patient outcomes, and refine decision-making in colorectal cancer care.
Read Announcement- Drug:
- Signatera
- Announced Date:
- September 8, 2024
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2024 European Society for Medical Oncology (ESMO) Congress taking place Sept. 13-16 in Barcelona, Spain.
AI Summary
Natera, Inc. announced new data on its personalized, tumor-informed molecular residual disease (MRD) test, Signatera, will be presented at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain from September 13-16. The company, known for its expertise in cell-free DNA and genetic testing, is preparing to showcase findings that underline the test’s ability to detect remaining cancer and predict future outcomes for cancer patients. In addition to colorectal cancer data, Signatera will be featured in presentations addressing breast cancer and squamous cell carcinoma of the head and neck. These new datasets from Natera and its collaborators highlight the potential of Signatera to guide treatment decisions by identifying residual disease early, thereby potentially improving long-term survival and patient management in various cancers.
Read Announcement- Drug:
- Signatera
- Announced Date:
- June 27, 2024
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced a new gastroesophageal cancer trial, DECIPHER, that will utilize the company's personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, to guide patient selection and assess the rate of MRD clearance in patients being treated for gastroesophageal cancer.
AI Summary
Natera, Inc. has launched a new clinical trial called DECIPHER for gastroesophageal cancer. In this study, the company will use its personalized, tumor-informed molecular residual disease (MRD) test, Signatera™, to choose patients for the trial and to check how well the treatment clears residual cancer cells after surgery.
DECIPHER is a phase II, single-arm trial testing the effectiveness of a new HER2-directed antibody-drug conjugate in patients with gastroesophageal adenocarcinoma. Patients who test positive with Signatera™ following chemotherapy and surgery will receive this investigational treatment instead of standard adjuvant chemotherapy. The trial will monitor MRD clearance as its main endpoint, offering a personalized approach that could give patients a better chance at a cure when standard treatments have failed to work effectively.
Read Announcement
SWOG 80702 FDA Regulatory Events
SWOG 80702 is a drug developed by Natera for the following indication: In Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SWOG 80702
- Announced Date:
- January 25, 2025
- Indication:
- In Colorectal Cancer
Announcement
Natera, Inc announced new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study.
AI Summary
Natera, Inc. announced promising new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study. This trial examined if patients with stage III colorectal cancer who tested positive with the Signatera™ test could benefit from enhanced treatment. About 1,000 patients, with blood samples taken after surgery, were given standard FOLFOX chemotherapy either with or without the addition of celecoxib, a commonly used anti-inflammatory drug.
The study showed that patients identified as Signatera-positive experienced a significant improvement in both disease-free and overall survival when celecoxib was added to their treatment. These results suggest that the Signatera test can help doctors personalize therapy by identifying patients who may benefit from treatment escalation. Overall, the findings mark a noteworthy step forward in using genetic testing to optimize care for colorectal cancer patients.
Read Announcement
MarketBeat All Access