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
Signatera, AFT-70, KUP-101, SWOG, NRG-GU015, IMvigor011, and Prospera. 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.
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:
- October 18, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced that 20 abstracts featuring its technology will be presented at the 2026 European Society for Medical Oncology (ESMO) Annual Congress, taking place October 23–26 in Madrid, Spain.
Read Announcement- Drug:
- Signatera
- Announced Date:
- September 1, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc. announced the publication of new data in Blood Neoplasia, validating the prognostic and predictive value of Signatera in patients with both newly diagnosed and relapsed/refractory (R/R) lymphoma.
Read Announcement- Drug:
- Signatera
- Announced Date:
- August 31, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced the publication of new data in Blood Neoplasia, validating the prognostic and predictive value of Signatera in patients with both newly diagnosed and relapsed/refractory (R/R) lymphoma.
Read Announcement- Drug:
- Signatera
- Announced Date:
- August 5, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced that it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of the Signatera test in muscle-invasive bladder cancer (MIBC) as a companion diagnostic (CDx).
AI Summary
Natera, Inc. has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval of its Signatera test as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC). The test is designed to support treatment decisions by detecting molecular residual disease, which can indicate that cancer remains after treatment and help identify patients at higher risk of recurrence.
The submission expands Natera’s growing presence in Japan. In June, Signatera received PMDA approval for colorectal cancer, becoming Japan’s first PMDA-approved molecular residual disease test. Bladder cancer affects more than 34,000 people in Japan each year, and about 20% to 25% of newly diagnosed cases worldwide are muscle-invasive. MIBC is a more aggressive form of bladder cancer with greater recurrence risk and more complex treatment needs. Natera said it looks forward to working with the PMDA to bring precision diagnostic tools to Japanese patients and improve care worldwide.
Read Announcement- Drug:
- Signatera
- Announced Date:
- July 6, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced the publication of new data in JAMA Oncology, evaluating the utility of Signatera, its personalized molecular residual disease (MRD) test, in patients with resected colorectal liver metastases (CRLM).
AI Summary
Natera, Inc. announced new data published in JAMA Oncology showing that its personalized molecular residual disease (MRD) test, Signatera, may help guide treatment for patients with resected colorectal liver metastases (CRLM). The study analyzed 298 patients from the GALAXY trial, part of the CIRCULATE-Japan program, with a median follow-up of 43 months.
Researchers found that patients who were MRD-positive appeared to live longer when they received adjuvant chemotherapy, while MRD-negative patients did not see a clear survival benefit from the same treatment. This suggests Signatera may help doctors better identify which patients are most likely to benefit from adjuvant chemotherapy after surgery.
Natera said the results add important overall survival data in a setting where doctors have had limited tools to decide who should get additional treatment. The company said the findings support using Signatera to personalize care for each patient.
Read Announcement- Drug:
- Signatera
- Announced Date:
- May 29, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc. announced a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers.
AI Summary
Natera, Inc. announced a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company that is developing immunotherapies for hard-to-treat cancers. Under the agreement, Natera’s Signatera test will be used in Diakonos’ Phase I/II clinical trial to help measure how patients respond to an investigational dendritic cell therapy. This type of test looks for small amounts of tumor DNA in the blood and can show whether treatment may be working.
The partnership is meant to support Diakonos’ research by giving doctors and scientists a clearer way to track molecular changes during the trial. By using Signatera, the companies hope to learn more about how the therapy affects patients with advanced cancers and whether it may help guide future treatment decisions. The collaboration highlights growing interest in using blood-based testing to better understand cancer immunotherapy results.
Read Announcement- Drug:
- Signatera
- Announced Date:
- May 15, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC.
AI Summary
Natera, Inc. said the U.S. Food and Drug Administration has approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) immunotherapy in muscle-invasive bladder cancer, or MIBC. This means the test can help doctors identify which patients may benefit from this treatment after surgery.
The company said this is the first FDA-approved use of personalized molecular residual disease, or MRD, testing to guide treatment decisions. Natera said the approval supports its Treatment on MRD, or TOMR, approach by helping direct treatment to patients who still show signs of disease, while avoiding extra treatment for patients who do not.
Natera called the approval an important step toward more precise care for people with MIBC.
Read Announcement- Drug:
- Signatera
- Announced Date:
- February 2, 2026
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signatera™CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq®).
AI Summary
Natera, Inc. has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for Signatera™ CDx, a test designed to detect molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC). The test is intended to identify patients who may benefit from treatment with atezolizumab (Tecentriq®) by detecting tiny amounts of tumor DNA left after initial therapy.
The submission is supported by landmark phase 3 clinical data that validate using MRD to guide treatment decisions in bladder cancer. If cleared, Signatera CDx could serve as a companion diagnostic to help clinicians decide which MIBC patients should receive atezolizumab based on MRD status.
Alexey Aleshin, Natera’s oncology chief, said the PMA filing is an important step toward making MRD-guided care a reality and that Signatera CDx could be the first companion diagnostic MRD test to help improve patient outcomes.
Read Announcement- Drug:
- Signatera
- Announced Date:
- December 16, 2025
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc. announced the publication of new findings from the I-SPY 2 trial in Nature Communications.
Read Announcement- Drug:
- Signatera
- Announced Date:
- September 30, 2025
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announcedthe publication of a peer-reviewed manuscript in the Journal of Clinical Oncology - Precision Oncology (JCO PO).
AI Summary
Natera, Inc. announced the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO). It presents results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker in germ cell tumors, including testicular cancer.
This retrospective study analyzed 324 plasma samples from 74 patients across stages I to III. The Signatera test measured ctDNA before, during, and after treatment. Pre-surgery ctDNA positivity was 91.6% in stage I and 100% in stages II and III. After surgery, ctDNA-positive patients had shorter event-free survival (EFS HR 5.11; p=0.019), while conventional serum tumor markers showed no significant difference.
During surveillance, ctDNA-positive patients experienced a much shorter EFS (HR 12.45; p<0.0001), outperforming standard markers. Investigators say Signatera could better identify patients at high risk of recurrence or progression, potentially improving how testicular cancer is monitored and managed.
Read Announcement- Drug:
- Signatera
- Announced Date:
- August 25, 2025
- Indication:
- MRD Test for cancer therapies
Announcement
Natera, Inc announced that it will present new data at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, taking place September 6 - 9 in Barcelona, Spain.
AI Summary
Natera, Inc., a global leader in cell-free DNA and precision medicine, will present new data at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, held September 6–9 in Barcelona, Spain. The findings highlight the clinical utility of Signatera in lung cancer care.
An oral presentation will feature an analysis of early-stage, resectable non-small cell lung cancer (NSCLC) patients. It shows that Signatera status in the post-surgical molecular residual disease window strongly predicts both recurrence-free survival and overall survival. This study used Signatera Genome to improve personalized patient care through better post-surgical risk stratification.
Natera will also share additional data on the prognostic value of Signatera Genome for risk stratification in early-stage NSCLC.
Presentation schedule at WCLC:
• September 7, 3:22 PM CEST – Gaston Becharano, M.D.: Clinical performance of a tumor-informed whole genome ctDNA assay
• September 8, 10:30 AM CEST – Daniel Rosas, M.D.: Personalized ctDNA monitoring of treatment outcomes
• September 9, 10:00 AM CEST – Ken Masuda, M.D.: Prospective study of MRD and prognosis in curative-intent NSCLC
Read Announcement- 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
AFT-70 FDA Regulatory Events
AFT-70 is a drug developed by Natera for the following indication: Inhibitor Therapy in Breast 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:
- AFT-70
- Announced Date:
- October 5, 2026
- Indication:
- Inhibitor Therapy in Breast Cancer
Announcement
Alliance Foundation Trials, LLC and Natera, Inc. announced the launch of AFT-70 NAVIGATE, a randomized phase III trial evaluating a novel molecular residual disease (MRD)-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer.
Read Announcement
KUP-101 FDA Regulatory Events
KUP-101 is a drug developed by Natera for the following indication: in Advanced Skin Cancers.
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:
- KUP-101
- Announced Date:
- August 12, 2026
- Indication:
- in Advanced Skin Cancers
Announcement
Natera, Inc announced a new collaboration regarding a Phase 1 clinical trial, sponsored by Kupando Therapeutics.
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:
- December 18, 2025
- Indication:
- In Colorectal Cancer
Announcement
Natera, Inc announced the publication of findings from the randomized, phase III CALGB (Alliance)/SWOG 80702 study in JAMA Oncology.
AI Summary
Natera announced the JAMA Oncology publication of the randomized, phase III CALGB (Alliance)/SWOG 80702 study. The trial evaluated postoperative personalized circulating tumor DNA (ctDNA) testing with Signatera in 940 patients with stage III colorectal cancer who were randomized to FOLFOX chemotherapy with or without celecoxib.
In patients who were Signatera-positive after surgery, adding celecoxib reduced the risk of cancer recurrence and death by about 40%. Celecoxib improved disease-free survival (adjusted HR=0.61; 3‑year DFS 41.0% vs 22.6%) and overall survival (adjusted HR=0.62; 5‑year OS 61.6% vs 39.9%). Signatera-negative patients showed no significant benefit from celecoxib.
The celecoxib benefit in Signatera-positive patients was independent of demographic, pathologic, or molecular factors, including PIK3CA status. A subset meeting stricter sample quality criteria showed an even larger benefit (adjusted HR=0.49), supporting Signatera’s predictive and prognostic value in guiding adjuvant therapy.
Read Announcement- 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
NRG-GU015 FDA Regulatory Events
NRG-GU015 is a drug developed by Natera for the following indication: In 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:
- NRG-GU015
- Announced Date:
- August 28, 2025
- Indication:
- In Bladder Cancer
Announcement
Natera, Inc announced the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC).
AI Summary
Natera, Inc. activated the ARCHER (NRG-GU015) trial, a randomized phase III study in muscle-invasive bladder cancer (MIBC). It will test a shorter radiation course against current standard therapy to see if outcomes stay comparable while easing treatment.
The trial includes Signatera, Natera’s MRD test, as a secondary endpoint. Results will be collected during treatment and follow-up to monitor ctDNA clearance and signal recurrence.
Sponsored by NRG Oncology via the National Cancer Institute’s network, ARCHER will enroll at more than 100 sites in the U.S. and Canada. Natera will also study urine tumor DNA as an exploratory endpoint.
“By using ctDNA to monitor treatment response and early recurrence, we hope to improve outcomes for MIBC patients,” said study co-chair Catherine Spina, M.D. “ARCHER could safely reduce therapy intensity, ease patient burden and guide more precise care,” added Minetta Liu, M.D.
Read Announcement
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
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
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
