{"success":true,"data":{"pressRelease":{"id":"18986","rtpr_id":"nPnbGYD4Wa","ticker":"CAI","exchange":"NASDAQ","all_tickers":["CAI"],"title":"Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies","author":"PR Newswire","published_at":"2026-05-04T12:30:00.304Z","article_body":"Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies\n\nPR Newswire\n\nIRVING, Texas, May 4, 2026\n\nIRVING, Texas, May 4, 2026 /PRNewswire/ -- Caris Life Sciences\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4679023-1&h=2626683867&u=https%3A%2F%2Fwww.carislifesciences.com%2F&a=Caris+Life+Sciences)\n(®) (NASDAQ: CAI), a leading, patient‑centric, next‑generation AI TechBio\ncompany and precision medicine pioneer, today announced that Caris\nChromoSeq™ has received MolDX approval, a key milestone supporting broader\nclinical access to Caris' comprehensive whole genome tumor profiling assay for\nmyeloid malignancies.\n\n(https://mma.prnewswire.com/media/830740/Caris_Life_Sciences_Logo.html)\n\nThe Molecular Diagnostic Services (MolDX) program, administered by Palmetto\nGBA on behalf of the Centers for Medicare & Medicaid Services (CMS),\nevaluates molecular diagnostic tests to determine whether they demonstrate\nclinical validity and utility to support coverage and reimbursement decisions.\nMolDX approval reflects a rigorous review of the test performance and medical\nusefulness, helping ensure that high‑value molecular diagnostics are\naccessible to appropriate patients.\n\nCaris ChromoSeq is the world's first and only ultra-deep whole genome\nsequencing (WGS) assay for myeloid malignancies. The assay sequences at\nunprecedented depth, up to eight times deeper than what is typically\nconsidered a deep whole genome sequencing run, enabling highly sensitive and\ncomprehensive detection of clinically relevant genomic alterations.\n\n\"Securing MolDX approval for Caris ChromoSeq represents an important step in\nexpanding access to highly informative genomic testing for patients with\ncomplex myeloid cancers,\" said Matthew Oberley, MD, PhD\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4679023-1&h=1005726832&u=https%3A%2F%2Fwww.carislifesciences.com%2Fbio%2Fmatthew-oberley-md-phd%2F&a=Matthew+Oberley%2C+MD%2C+PhD)\n, Senior Vice President, Chief Clinical Officer and Pathologist-in-Chief at\nCaris. \"Our goal is to replace fragmented diagnostic workflows with a single,\ncomprehensive assay that delivers clear, actionable insights to clinicians\nwhen time and accuracy matter most.\"\n\nCaris ChromoSeq is designed to support the comprehensive clinical genomic\nevaluation of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS),\nmyeloproliferative neoplasms (MPN) and other suspected myeloid malignancies.\nBy utilizing ultra‑deep whole genome analysis, ChromoSeq enables detection\nof single‑nucleotide variants, insertions and deletions, copy number\nalterations, structural variants and gene fusions that are critical for\ndiagnosis, risk stratification and clinical decision‑making.\n\nUnlike traditional diagnostic workflows that rely on multiple separate assays,\nCaris ChromoSeq is designed to replace serial testing with one integrated\napproach, reducing complexity and minimizing delays in care. Results are\nconsolidated into a single, easy‑to‑interpret clinical report to support\ntimely treatment decisions.\n\nFor clinicians, this milestone reinforces confidence in the test's clinical\nperformance and evidentiary foundation. For patients, this approval represents\nprogress toward broader access to comprehensive genomic insights that can\ninform diagnosis and management of genetically complex myeloid diseases.\n\nAbout Caris Life Sciences\nCaris Life Sciences(®) (Caris) is a leading, patient-centric,\nnext-generation AI TechBio company and precision medicine pioneer actively\ndeveloping and commercializing innovative solutions to transform healthcare.\nThrough comprehensive molecular profiling (Whole Genome, Whole Exome and Whole\nTranscriptome Sequencing), advanced AI and machine learning, Caris has created\nthe large-scale, multimodal clinico-genomic database and computing capability\nneeded to analyze and further unravel the molecular complexity of disease.\nThis convergence of next-generation sequencing, AI and machine learning\ntechnologies and high-performance computing provides a differentiated platform\nfor developing the latest generation of advanced precision medicine diagnostic\nsolutions for early detection, diagnosis, monitoring, therapy selection and\ndrug development. \n\nCaris was founded with a vision to realize the potential of precision medicine\nto improve the human condition. Headquartered in Irving, Texas, Caris has\noffices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel,\nSwitzerland. Caris or its distributor partners provide services in the U.S.\nand other international markets. \n\nForward Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe federal securities laws. All statements other than statements of\nhistorical facts contained in this press release are forward-looking\nstatements, including statements regarding our business, solutions,\nplans, objectives, goals, industry trends, financial outlook and guidance.\nIn some cases forward-looking statements can be identified by words such as\n\"may,\" \"will,\" \"should,\" \"would,\" \"expect,\" \"plan,\" \"anticipate,\" \"could,\"\n\"intend,\" \"target,\" \"project,\" \"contemplate,\" \"believe,\" \"estimate,\"\n\"predict,\" \"potential\" or \"continue\" or similar expressions.\n\nYou should not rely upon forward-looking statements as predictions of future\nevents. Although we believe that the expectations reflected in these\nforward-looking statements are reasonable based on information currently\navailable to us, we cannot guarantee that the future results, discoveries,\nlevels of activity, performance or events and circumstances reflected in\nforward-looking statements will be achieved or occur. Forward-looking\nstatements involve known and unknown risks and uncertainties, some of which\nare beyond our control. Risks and uncertainties that could cause our actual\nresults to differ materially from those indicated or implied by the\nforward-looking statements in this press release include, among other things:\ndevelopments in the precision medicine industry; our future financial\nperformance, results of operations or other operational results or metrics;\ndevelopment, analytical and clinical validation, timing and performance of\nfuture solutions by us and our competitors; commercial market acceptance for\nour solutions, including acceptance of preventive as well as diagnostic\ntesting paradigms, and our ability to meet resulting demand; the rapidly\nevolving competitive environment in which we operate; third-party payer\nreimbursement and coverage decisions related to our solutions; risks related\nto data management, storage, and processing capabilities and our ability to\nintegrate and deploy artificial intelligence and advanced data analytics\ntechnologies; our ability to protect and enhance our intellectual property;\nregulatory requirements, decisions or approvals (including the timing and\nconditions thereof) related to our solutions; reliance on third-party\nsuppliers; risks related to data security, patient privacy, and compliance\nwith healthcare data protection regulations as well as potential cybersecurity\nthreats to our data platforms; our compliance with laws and regulations; the\noutcome of government investigations and litigation; risks related to our\nindebtedness; and our ability to hire and retain key personnel as well as\nrisks, uncertainties, and other factors described in the section titled \"Risk\nFactors\" and elsewhere in our Annual Report on Form 10-K filed with the\nSecurities and Exchange Commission (SEC) on March 3, 2026, and in our other\nfilings we make with the SEC from time to time. We undertake no obligation to\nupdate any forward-looking statements to reflect changes in\nevents, circumstances or our beliefs after the date of this press release,\nexcept as required by law.\n\nCaris Life Sciences Media:\nCorporate Communications\nCorpComm@CarisLS.com (mailto:CorpComm@CarisLS.com)\n214.294.5606\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/caris-life-sciences-receives-moldx-approval-for-caris-chromoseq-advancing-access-to-comprehensive-genomic-profiling-for-myeloid-malignancies-302760779.html\n(https://www.prnewswire.com/news-releases/caris-life-sciences-receives-moldx-approval-for-caris-chromoseq-advancing-access-to-comprehensive-genomic-profiling-for-myeloid-malignancies-302760779.html)\n\nSOURCE Caris Life Sciences\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/830740/Caris_Life_Sciences_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPnbGYD4Wa","title":"Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies","author":"PR Newswire","ticker":"CAI","created":"2026-05-04T12:30:00.304Z","tickers":["CAI"],"exchange":"NASDAQ","article_body":"Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies\n\nPR Newswire\n\nIRVING, Texas, May 4, 2026\n\nIRVING, Texas, May 4, 2026 /PRNewswire/ -- Caris Life Sciences\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4679023-1&h=2626683867&u=https%3A%2F%2Fwww.carislifesciences.com%2F&a=Caris+Life+Sciences)\n(®) (NASDAQ: CAI), a leading, patient‑centric, next‑generation AI TechBio\ncompany and precision medicine pioneer, today announced that Caris\nChromoSeq™ has received MolDX approval, a key milestone supporting broader\nclinical access to Caris' comprehensive whole genome tumor profiling assay for\nmyeloid malignancies.\n\n(https://mma.prnewswire.com/media/830740/Caris_Life_Sciences_Logo.html)\n\nThe Molecular Diagnostic Services (MolDX) program, administered by Palmetto\nGBA on behalf of the Centers for Medicare & Medicaid Services (CMS),\nevaluates molecular diagnostic tests to determine whether they demonstrate\nclinical validity and utility to support coverage and reimbursement decisions.\nMolDX approval reflects a rigorous review of the test performance and medical\nusefulness, helping ensure that high‑value molecular diagnostics are\naccessible to appropriate patients.\n\nCaris ChromoSeq is the world's first and only ultra-deep whole genome\nsequencing (WGS) assay for myeloid malignancies. The assay sequences at\nunprecedented depth, up to eight times deeper than what is typically\nconsidered a deep whole genome sequencing run, enabling highly sensitive and\ncomprehensive detection of clinically relevant genomic alterations.\n\n\"Securing MolDX approval for Caris ChromoSeq represents an important step in\nexpanding access to highly informative genomic testing for patients with\ncomplex myeloid cancers,\" said Matthew Oberley, MD, PhD\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4679023-1&h=1005726832&u=https%3A%2F%2Fwww.carislifesciences.com%2Fbio%2Fmatthew-oberley-md-phd%2F&a=Matthew+Oberley%2C+MD%2C+PhD)\n, Senior Vice President, Chief Clinical Officer and Pathologist-in-Chief at\nCaris. \"Our goal is to replace fragmented diagnostic workflows with a single,\ncomprehensive assay that delivers clear, actionable insights to clinicians\nwhen time and accuracy matter most.\"\n\nCaris ChromoSeq is designed to support the comprehensive clinical genomic\nevaluation of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS),\nmyeloproliferative neoplasms (MPN) and other suspected myeloid malignancies.\nBy utilizing ultra‑deep whole genome analysis, ChromoSeq enables detection\nof single‑nucleotide variants, insertions and deletions, copy number\nalterations, structural variants and gene fusions that are critical for\ndiagnosis, risk stratification and clinical decision‑making.\n\nUnlike traditional diagnostic workflows that rely on multiple separate assays,\nCaris ChromoSeq is designed to replace serial testing with one integrated\napproach, reducing complexity and minimizing delays in care. Results are\nconsolidated into a single, easy‑to‑interpret clinical report to support\ntimely treatment decisions.\n\nFor clinicians, this milestone reinforces confidence in the test's clinical\nperformance and evidentiary foundation. For patients, this approval represents\nprogress toward broader access to comprehensive genomic insights that can\ninform diagnosis and management of genetically complex myeloid diseases.\n\nAbout Caris Life Sciences\nCaris Life Sciences(®) (Caris) is a leading, patient-centric,\nnext-generation AI TechBio company and precision medicine pioneer actively\ndeveloping and commercializing innovative solutions to transform healthcare.\nThrough comprehensive molecular profiling (Whole Genome, Whole Exome and Whole\nTranscriptome Sequencing), advanced AI and machine learning, Caris has created\nthe large-scale, multimodal clinico-genomic database and computing capability\nneeded to analyze and further unravel the molecular complexity of disease.\nThis convergence of next-generation sequencing, AI and machine learning\ntechnologies and high-performance computing provides a differentiated platform\nfor developing the latest generation of advanced precision medicine diagnostic\nsolutions for early detection, diagnosis, monitoring, therapy selection and\ndrug development. \n\nCaris was founded with a vision to realize the potential of precision medicine\nto improve the human condition. Headquartered in Irving, Texas, Caris has\noffices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel,\nSwitzerland. Caris or its distributor partners provide services in the U.S.\nand other international markets. \n\nForward Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe federal securities laws. All statements other than statements of\nhistorical facts contained in this press release are forward-looking\nstatements, including statements regarding our business, solutions,\nplans, objectives, goals, industry trends, financial outlook and guidance.\nIn some cases forward-looking statements can be identified by words such as\n\"may,\" \"will,\" \"should,\" \"would,\" \"expect,\" \"plan,\" \"anticipate,\" \"could,\"\n\"intend,\" \"target,\" \"project,\" \"contemplate,\" \"believe,\" \"estimate,\"\n\"predict,\" \"potential\" or \"continue\" or similar expressions.\n\nYou should not rely upon forward-looking statements as predictions of future\nevents. Although we believe that the expectations reflected in these\nforward-looking statements are reasonable based on information currently\navailable to us, we cannot guarantee that the future results, discoveries,\nlevels of activity, performance or events and circumstances reflected in\nforward-looking statements will be achieved or occur. Forward-looking\nstatements involve known and unknown risks and uncertainties, some of which\nare beyond our control. Risks and uncertainties that could cause our actual\nresults to differ materially from those indicated or implied by the\nforward-looking statements in this press release include, among other things:\ndevelopments in the precision medicine industry; our future financial\nperformance, results of operations or other operational results or metrics;\ndevelopment, analytical and clinical validation, timing and performance of\nfuture solutions by us and our competitors; commercial market acceptance for\nour solutions, including acceptance of preventive as well as diagnostic\ntesting paradigms, and our ability to meet resulting demand; the rapidly\nevolving competitive environment in which we operate; third-party payer\nreimbursement and coverage decisions related to our solutions; risks related\nto data management, storage, and processing capabilities and our ability to\nintegrate and deploy artificial intelligence and advanced data analytics\ntechnologies; our ability to protect and enhance our intellectual property;\nregulatory requirements, decisions or approvals (including the timing and\nconditions thereof) related to our solutions; reliance on third-party\nsuppliers; risks related to data security, patient privacy, and compliance\nwith healthcare data protection regulations as well as potential cybersecurity\nthreats to our data platforms; our compliance with laws and regulations; the\noutcome of government investigations and litigation; risks related to our\nindebtedness; and our ability to hire and retain key personnel as well as\nrisks, uncertainties, and other factors described in the section titled \"Risk\nFactors\" and elsewhere in our Annual Report on Form 10-K filed with the\nSecurities and Exchange Commission (SEC) on March 3, 2026, and in our other\nfilings we make with the SEC from time to time. We undertake no obligation to\nupdate any forward-looking statements to reflect changes in\nevents, circumstances or our beliefs after the date of this press release,\nexcept as required by law.\n\nCaris Life Sciences Media:\nCorporate Communications\nCorpComm@CarisLS.com (mailto:CorpComm@CarisLS.com)\n214.294.5606\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/caris-life-sciences-receives-moldx-approval-for-caris-chromoseq-advancing-access-to-comprehensive-genomic-profiling-for-myeloid-malignancies-302760779.html\n(https://www.prnewswire.com/news-releases/caris-life-sciences-receives-moldx-approval-for-caris-chromoseq-advancing-access-to-comprehensive-genomic-profiling-for-myeloid-malignancies-302760779.html)\n\nSOURCE Caris Life Sciences\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/830740/Caris_Life_Sciences_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-05-04T12:30:00.367755655Z","server_sent_at_ms":1777897800367},"received_at":"2026-05-04T12:30:00.446Z","source_url":"https://www.prnewswire.com/news-releases/caris-life-sciences-receives-moldx-approval-for-caris-chromoseq-advancing-access-to-comprehensive-genomic-profiling-for-myeloid-malignancies-302760779.html"},"analysis":{"id":"13791","press_release_id":"18986","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Caris Life Sciences announced MolDX approval for Caris ChromoSeq, supporting broader clinical access to its comprehensive whole genome tumor profiling assay for myeloid malignancies.\n\nThe approval, administered by Palmetto GBA on behalf of CMS, validates the test's clinical utility and is a critical step toward securing Medicare coverage and reimbursement.\n\nCaris ChromoSeq is designed to replace fragmented diagnostic workflows with a single, ultra-deep sequencing approach for detecting genomic alterations in conditions like AML and MDS.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"MolDX approval paves the way for Medicare reimbursement, unlocking a major revenue channel for Caris ChromoSeq."},"keyFigures":{},"quotedText":"Securing MolDX approval for Caris ChromoSeq represents an important step in expanding access to highly informative genomic testing for patients with complex myeloid cancers","namedEntities":{"people":[{"name":"Matthew Oberley, MD, PhD","role":"Senior Vice President, Chief Clinical Officer and Pathologist-in-Chief"}],"products":["Caris ChromoSeq"],"companies":[{"name":"Caris Life Sciences","ticker":"CAI"},{"name":"Palmetto GBA","relationship":"MolDX program administrator"},{"name":"Centers for Medicare & Medicaid Services","relationship":"regulatory body / payer"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"MolDX approval is a critical commercial milestone for diagnostic assays, serving as the primary determinant for Medicare coverage and reimbursement. This approval unlocks a significant payer channel for Caris ChromoSeq, the company's differentiated ultra-deep whole genome sequencing test for myeloid malignancies."},"tickerRelevance":{"others":[],"primary":"CAI"},"globalImportance":35,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap","eventGravity":"regulatory-reimbursement-approval","sectorWeight":"diagnostics-life-sciences"}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Caris Life Sciences announced MolDX approval for Caris ChromoSeq, supporting broader clinical access to its comprehensive whole genome tumor profiling assay for myeloid malignancies.\n\nThe approval, administered by Palmetto GBA on behalf of CMS, validates the test's clinical utility and is a critical step toward securing Medicare coverage and reimbursement.\n\nCaris ChromoSeq is designed to replace fragmented diagnostic workflows with a single, ultra-deep sequencing approach for detecting genomic alterations in conditions like AML and MDS.","key_figures":{},"named_entities":{"people":[{"name":"Matthew Oberley, MD, PhD","role":"Senior Vice President, Chief Clinical Officer and Pathologist-in-Chief"}],"products":["Caris ChromoSeq"],"companies":[{"name":"Caris Life Sciences","ticker":"CAI"},{"name":"Palmetto GBA","relationship":"MolDX program administrator"},{"name":"Centers for Medicare & Medicaid Services","relationship":"regulatory body / payer"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:a2703c5a1b5285fe","schema_hash":"sha256:1f8af1196c7db48c","created_at":"2026-05-04T15:39:02.823Z","global_importance":35,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap","eventGravity":"regulatory-reimbursement-approval","sectorWeight":"diagnostics-life-sciences"}},"durationMs":45883,"modelName":"glm-4.7"}}