{"success":true,"data":{"pressRelease":{"id":"149546","rtpr_id":"nBwc4n0gFa-20260922","ticker":"NTRA","exchange":"NASDAQ","all_tickers":["NTRA"],"title":"Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer","author":"Business Wire","published_at":"2026-09-22T12:00:02.523Z","article_body":"Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic\nin Muscle-Invasive Bladder Cancer\n\nSecond PMDA approval for Signatera in three months and first PMDA-approved CDx\nin MRD-guided care; commercial launch expected in 1H’27, pending final\nreimbursement and pricing\n\nNatera, Inc.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=Natera%2C+Inc.&index=1&md5=9ba46ea286efc0f10c6620c90fb64b3b)\n(NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today\nannounced that its Signatera test has received regulatory approval from\nJapan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion\ndiagnostic (CDx) in muscle-invasive bladder cancer (MIBC).\n\nThis approval supports the use of the Signatera test to guide adjuvant\natezolizumab (Tecentriq®) treatment decisions in patients with MIBC. Natera\nexpects to commercially launch Signatera for MIBC in Japan in the first half\nof 2027, following the PMDA’s approval of atezolizumab in MIBC.\n\nRegulatory approval was supported by data from IMvigor011, a randomized,\ndouble-blind phase III clinical trial that evaluated Signatera-guided adjuvant\natezolizumab in patients with MIBC. The trial included more than 20\nparticipating sites in Japan, giving Japanese clinicians firsthand experience\nwith Signatera-guided treatment in this setting.\n\nThis marks Signatera’s second PMDA authorization in Japan, after receiving\napproval in colorectal cancer in June 2026. It follows the U.S. Food and Drug\nAdministration's (FDA) approval of Signatera as a CDx for adjuvant\natezolizumab in MIBC (and the approval by the FDA of atezolizumab), as well as\nthe recently published Category 1 recommendation for MRD-guided adjuvant\natezolizumab in the National Comprehensive Cancer Network® (NCCN®) Clinical\nPractice Guidelines for Bladder Cancer.\n\nBladder cancer affects more than 34,000 people in Japan each year,(1) with\napproximately 20–25% of newly diagnosed cases classified as\nmuscle-invasive.(2) MIBC carries a higher risk of recurrence and greater\ntreatment complexity than earlier-stage disease, underscoring the need for\nprecision tools that can help clinicians individualize treatment decisions in\nthe adjuvant setting.\n\n“We look forward to launching this second Signatera MRD indication in Japan,\ngiving patients with muscle-invasive bladder cancer a proven diagnostic tool\nto guide treatment decisions in the first year after surgery,” said Alexey\nAleshin, M.D., corporate chief medical officer and general manager of\noncology, Natera. “We value our growing partnership with the Japanese\noncology community, which has been a leader in adopting MRD into clinical\ntrials and into clinical practice.”\n\nReferences\n\n\n 1. World Cancer Research Fund International. Bladder cancer statistics. Accessed\nJune 26, 2026. \nhttps://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.wcrf.org%2Fpreventing-cancer%2Fcancer-statistics%2Fbladder-cancer-statistics%2F&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=https%3A%2F%2Fwww.wcrf.org%2Fpreventing-cancer%2Fcancer-statistics%2Fbladder-cancer-statistics%2F&index=2&md5=71438261419bbd477c5bb9e0b62bb32d)\n\n 2. Gakis G. Management of Muscle-invasive Bladder Cancer in the 2020s: Challenges\nand Perspectives. Eur. Urol. Focus. 2020;6(4):632–638.\n\nAbout Natera\n\nNatera is a global leader in cell-free DNA and precision medicine, dedicated\nto oncology, women’s health, and organ health. We aim to make personalized\ngenetic testing and diagnostics part of the standard-of-care to protect health\nand inform earlier, more targeted interventions that help lead to longer,\nhealthier lives. Natera’s tests are supported by more than 400 peer-reviewed\npublications that demonstrate excellent performance. Natera operates ISO\n13485-certified and CAP-accredited laboratories certified under the Clinical\nLaboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos,\nCalifornia, and through Foresight Diagnostics, its subsidiary, operates an ISO\n27001-certified and CAP-accredited laboratory certified under CLIA in Boulder,\nColorado. For more information, visit www.natera.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.natera.com&index=3&md5=7e9608558064802140be8bc13a215120)\n.\n\nForward-Looking Statements\n\nAll statements other than statements of historical facts contained in this\npress release are forward-looking statements and are not a representation that\nNatera’s plans, estimates, or expectations will be achieved. These\nforward-looking statements represent Natera’s expectations as of the date of\nthis press release, and Natera disclaims any obligation to update the\nforward-looking statements. These forward-looking statements are subject to\nknown and unknown risks and uncertainties that may cause actual results to\ndiffer materially, including with respect to our efforts to develop and\ncommercialize new product offerings, whether the results of clinical or other\nstudies will support the use of our product offerings, the impact of results\nof such studies, our expectations of the reliability, accuracy, and\nperformance of our tests, or of the benefits of our tests and product\nofferings to patients, providers, and payers. Additional risks and\nuncertainties are discussed in greater detail in \"Risk Factors\" in Natera’s\nrecent filings on Forms 10-K and 10-Q, and in other filings Natera makes with\nthe SEC from time to time. These documents are available at\nwww.natera.com/investors\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com%2Finvestors&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.natera.com%2Finvestors&index=4&md5=8fc7df35106c4635ec276ec98570a6ed)\nand www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.sec.gov&index=5&md5=63cd1c4d0aa0db620524b7ff4341e29e)\n.\n\nNotes\n\nTecentriq® (atezolizumab) is a registered trademark of Genentech, a member of\nthe Roche Group.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260922775835/en/\n(https://www.businesswire.com/news/home/20260922775835/en/)\n\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com \n(mailto:investor@natera.com) \nMedia: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc.,\npr@natera.com (mailto:pr@natera.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBwc4n0gFa-20260922","title":"Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer","author":"Business Wire","ticker":"NTRA","created":"2026-09-22T12:00:02.523Z","tickers":["NTRA"],"exchange":"NASDAQ","article_body":"Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic\nin Muscle-Invasive Bladder Cancer\n\nSecond PMDA approval for Signatera in three months and first PMDA-approved CDx\nin MRD-guided care; commercial launch expected in 1H’27, pending final\nreimbursement and pricing\n\nNatera, Inc.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=Natera%2C+Inc.&index=1&md5=9ba46ea286efc0f10c6620c90fb64b3b)\n(NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today\nannounced that its Signatera test has received regulatory approval from\nJapan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion\ndiagnostic (CDx) in muscle-invasive bladder cancer (MIBC).\n\nThis approval supports the use of the Signatera test to guide adjuvant\natezolizumab (Tecentriq®) treatment decisions in patients with MIBC. Natera\nexpects to commercially launch Signatera for MIBC in Japan in the first half\nof 2027, following the PMDA’s approval of atezolizumab in MIBC.\n\nRegulatory approval was supported by data from IMvigor011, a randomized,\ndouble-blind phase III clinical trial that evaluated Signatera-guided adjuvant\natezolizumab in patients with MIBC. The trial included more than 20\nparticipating sites in Japan, giving Japanese clinicians firsthand experience\nwith Signatera-guided treatment in this setting.\n\nThis marks Signatera’s second PMDA authorization in Japan, after receiving\napproval in colorectal cancer in June 2026. It follows the U.S. Food and Drug\nAdministration's (FDA) approval of Signatera as a CDx for adjuvant\natezolizumab in MIBC (and the approval by the FDA of atezolizumab), as well as\nthe recently published Category 1 recommendation for MRD-guided adjuvant\natezolizumab in the National Comprehensive Cancer Network® (NCCN®) Clinical\nPractice Guidelines for Bladder Cancer.\n\nBladder cancer affects more than 34,000 people in Japan each year,(1) with\napproximately 20–25% of newly diagnosed cases classified as\nmuscle-invasive.(2) MIBC carries a higher risk of recurrence and greater\ntreatment complexity than earlier-stage disease, underscoring the need for\nprecision tools that can help clinicians individualize treatment decisions in\nthe adjuvant setting.\n\n“We look forward to launching this second Signatera MRD indication in Japan,\ngiving patients with muscle-invasive bladder cancer a proven diagnostic tool\nto guide treatment decisions in the first year after surgery,” said Alexey\nAleshin, M.D., corporate chief medical officer and general manager of\noncology, Natera. “We value our growing partnership with the Japanese\noncology community, which has been a leader in adopting MRD into clinical\ntrials and into clinical practice.”\n\nReferences\n\n\n 1. World Cancer Research Fund International. Bladder cancer statistics. Accessed\nJune 26, 2026. \nhttps://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.wcrf.org%2Fpreventing-cancer%2Fcancer-statistics%2Fbladder-cancer-statistics%2F&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=https%3A%2F%2Fwww.wcrf.org%2Fpreventing-cancer%2Fcancer-statistics%2Fbladder-cancer-statistics%2F&index=2&md5=71438261419bbd477c5bb9e0b62bb32d)\n\n 2. Gakis G. Management of Muscle-invasive Bladder Cancer in the 2020s: Challenges\nand Perspectives. Eur. Urol. Focus. 2020;6(4):632–638.\n\nAbout Natera\n\nNatera is a global leader in cell-free DNA and precision medicine, dedicated\nto oncology, women’s health, and organ health. We aim to make personalized\ngenetic testing and diagnostics part of the standard-of-care to protect health\nand inform earlier, more targeted interventions that help lead to longer,\nhealthier lives. Natera’s tests are supported by more than 400 peer-reviewed\npublications that demonstrate excellent performance. Natera operates ISO\n13485-certified and CAP-accredited laboratories certified under the Clinical\nLaboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos,\nCalifornia, and through Foresight Diagnostics, its subsidiary, operates an ISO\n27001-certified and CAP-accredited laboratory certified under CLIA in Boulder,\nColorado. For more information, visit www.natera.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.natera.com&index=3&md5=7e9608558064802140be8bc13a215120)\n.\n\nForward-Looking Statements\n\nAll statements other than statements of historical facts contained in this\npress release are forward-looking statements and are not a representation that\nNatera’s plans, estimates, or expectations will be achieved. These\nforward-looking statements represent Natera’s expectations as of the date of\nthis press release, and Natera disclaims any obligation to update the\nforward-looking statements. These forward-looking statements are subject to\nknown and unknown risks and uncertainties that may cause actual results to\ndiffer materially, including with respect to our efforts to develop and\ncommercialize new product offerings, whether the results of clinical or other\nstudies will support the use of our product offerings, the impact of results\nof such studies, our expectations of the reliability, accuracy, and\nperformance of our tests, or of the benefits of our tests and product\nofferings to patients, providers, and payers. Additional risks and\nuncertainties are discussed in greater detail in \"Risk Factors\" in Natera’s\nrecent filings on Forms 10-K and 10-Q, and in other filings Natera makes with\nthe SEC from time to time. These documents are available at\nwww.natera.com/investors\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.natera.com%2Finvestors&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.natera.com%2Finvestors&index=4&md5=8fc7df35106c4635ec276ec98570a6ed)\nand www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54608483&newsitemid=20260922775835&lan=en-US&anchor=www.sec.gov&index=5&md5=63cd1c4d0aa0db620524b7ff4341e29e)\n.\n\nNotes\n\nTecentriq® (atezolizumab) is a registered trademark of Genentech, a member of\nthe Roche Group.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260922775835/en/\n(https://www.businesswire.com/news/home/20260922775835/en/)\n\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com \n(mailto:investor@natera.com) \nMedia: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc.,\npr@natera.com (mailto:pr@natera.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-22T12:00:04.107078108Z","server_sent_at_ms":1790078404107},"received_at":"2026-09-22T12:00:04.164Z","source_url":"https://www.businesswire.com/news/home/20260922775835/en/"},"analysis":{"id":"138834","press_release_id":"149546","analysis_json":{"industry":{"label":"Health Care Providers & Services","sector":"Health Care"},"redFlags":["Commercial launch pending final reimbursement and pricing decisions in Japan","Launch contingent on PMDA approval of atezolizumab in MIBC"],"eventType":"regulatory","narrative":"Natera's Signatera test received approval from Japan's PMDA as a companion diagnostic in muscle-invasive bladder cancer, supporting Signatera-guided adjuvant atezolizumab (Tecentriq) treatment decisions.\n\nThis is the second PMDA authorization for Signatera in three months, following colorectal cancer approval in June 2026, and the first PMDA-approved CDx in MRD-guided care.\n\nApproval was supported by the phase III IMvigor011 trial, which included more than 20 sites in Japan. Natera expects a Japanese commercial launch in the first half of 2027, pending final reimbursement and pricing decisions.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Signatera's international expansion accelerates -- second PMDA approval in three months opens Japan's MIBC market ahead of a 1H'27 launch."},"keyFigures":{"drugName":"Signatera","phaseOfTrial":"Phase 3","customDimensions":{"launch_timing":"1H 2027, pending final reimbursement and pricing","mibc_share_of_new_cases":"20-25%","bladder_cancer_cases_japan_per_year":"more than 34,000"}},"quotedText":"We look forward to launching this second Signatera MRD indication in Japan, giving patients with muscle-invasive bladder cancer a proven diagnostic tool to guide treatment decisions in the first year after surgery","namedEntities":{"people":[{"name":"Alexey Aleshin, M.D.","role":"corporate chief medical officer and general manager of oncology, Natera"},{"name":"Mike Brophy","role":"CFO"},{"name":"Lesley Bogdanow","role":"VP of Corporate Communications"}],"products":["Signatera","Tecentriq (atezolizumab)","IMvigor011"],"companies":[{"name":"Natera, Inc.","ticker":"NTRA","relationship":"filer"},{"name":"Genentech (Roche Group)","relationship":"partner (atezolizumab/Tecentriq manufacturer)"},{"name":"Foresight Diagnostics","relationship":"subsidiary"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Second PMDA approval for Signatera in three months and first PMDA-approved CDx in MRD-guided care, expanding Natera's addressable market in Japan. However, commercial launch is not until 1H'27 pending reimbursement and pricing, so revenue impact is delayed."},"tickerRelevance":{"others":[],"primary":"NTRA"},"globalImportance":40,"audienceRelevance":35,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"mid-cap growth","eventGravity":"regulatory approval (non-US, companion diagnostic)","sectorWeight":"diagnostics/oncology","revenueTiming":"delayed to 1H'27 pending reimbursement"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"Natera's Signatera test received approval from Japan's PMDA as a companion diagnostic in muscle-invasive bladder cancer, supporting Signatera-guided adjuvant atezolizumab (Tecentriq) treatment decisions.\n\nThis is the second PMDA authorization for Signatera in three months, following colorectal cancer approval in June 2026, and the first PMDA-approved CDx in MRD-guided care.\n\nApproval was supported by the phase III IMvigor011 trial, which included more than 20 sites in Japan. Natera expects a Japanese commercial launch in the first half of 2027, pending final reimbursement and pricing decisions.","key_figures":{"drugName":"Signatera","phaseOfTrial":"Phase 3","customDimensions":{"launch_timing":"1H 2027, pending final reimbursement and pricing","mibc_share_of_new_cases":"20-25%","bladder_cancer_cases_japan_per_year":"more than 34,000"}},"named_entities":{"people":[{"name":"Alexey Aleshin, M.D.","role":"corporate chief medical officer and general manager of oncology, Natera"},{"name":"Mike Brophy","role":"CFO"},{"name":"Lesley Bogdanow","role":"VP of Corporate Communications"}],"products":["Signatera","Tecentriq (atezolizumab)","IMvigor011"],"companies":[{"name":"Natera, Inc.","ticker":"NTRA","relationship":"filer"},{"name":"Genentech (Roche Group)","relationship":"partner (atezolizumab/Tecentriq manufacturer)"},{"name":"Foresight Diagnostics","relationship":"subsidiary"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-22T17:16:53.071Z","global_importance":40,"audience_relevance":35,"importance_components":{"tickerTier":"mid-cap growth","eventGravity":"regulatory approval (non-US, companion diagnostic)","sectorWeight":"diagnostics/oncology","revenueTiming":"delayed to 1H'27 pending reimbursement"}},"durationMs":6642,"modelName":"glm-5.3-flash"}}