{"id":980051,"date":"2026-07-09T07:08:09","date_gmt":"2026-07-09T11:08:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/"},"modified":"2026-07-09T07:08:09","modified_gmt":"2026-07-09T11:08:09","slug":"neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/","title":{"rendered":"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer"},"content":{"rendered":"

<\/p>\n

NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer<\/b><\/p>\n

Available within NEO PanTracer\u2122 Pro for prostate cancer and as a standalone test, PTEN IHC CDx identifies patients who may be eligible for TRUQAP\u00ae<\/sup><\/i><\/p>\n

FORT MYERS, Fla.–(BUSINESS WIRE<\/a>)–NeoGenomics, Inc.<\/b><\/a> (NASDAQ: NEO)<\/b>, a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca\u2019s recently approved targeted therapy TRUQAP<\/a>\u00ae<\/sup><\/a> (capivasertib).1<\/sup><\/p>\n

\nPTEN IHC CDx extends the company’s reach into urologic oncology, where community practices manage the majority of patients with advanced prostate cancer. Performed by NeoGenomics\u2019 pathologists across its national oncology laboratory network, the test is available as a standalone order or as part of NEO PanTracer\u2122 Pro<\/a> for prostate cancer, a comprehensive molecular workup that combines CGP and cancer-type-directed IHC testing in a single order built to evolve with new treatment options.<\/p>\n

\n\u201cClinicians treating this aggressive form of prostate cancer have long needed both a targeted therapy and a validated way to identify eligible patients,\u201d said Nathan Montgomery, Vice President, Medical Services, NeoGenomics. \u201cWith PTEN IHC CDx now integrated into NEO PanTracer Pro, community oncology practices have an FDA-approved companion diagnostic available through a single national laboratory partner, reflecting our commitment to providing the tools clinicians need for timely treatment decisions when new therapies become available.\u201d<\/p>\n

\nProstate cancer is the most common cancer in men in the United States, with more than 300,000 new cases and over 36,000 deaths annually.2<\/sup> Of the approximately 35,000 patients diagnosed each year with mAPMN\/S prostate cancer (formerly mHSPC), about one in four \u2013 or approximately 8,750 patients \u2013 have PTEN-deficient tumors.2,3<\/sup> PTEN protein loss is detectable through a tissue-based test at the time of diagnosis.4<\/sup><\/p>\n

About PTEN IHC CDx
\n
<\/b>NeoGenomics’ IHC companion diagnostic assay detects PTEN protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. Authorized by the FDA to identify patients with mAPMN\/S prostate cancer who may be eligible for TRUQAP\u00ae<\/sup>, the test is performed by NeoGenomics pathologists across its national oncology laboratory network. PTEN IHC CDx is available as a standalone order, delivering results in as few as one to two days, or as part of NEO PanTracer\u2122 Pro for prostate cancer, a comprehensive molecular workup offered in a single coordinated order that integrates CGP with cancer-type-directed IHC and ancillary testing for prostate carcinoma. The test has been approved in New York State.<\/p>\n

About NeoGenomics
\n
<\/b>NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to deliver timely, actionable insights that guide personalized care decisions. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, England.<\/p>\n

Forward Looking Statements
\n
<\/b>This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as \u201canticipate,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cforecast,\u201d \u201cgoal,\u201d \u201cproject,\u201d \u201cguidance,\u201d \u201cplan,\u201d \u201cpotential\u201d and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding the Company\u2019s strategy, planned future operations and development plans and initiatives, as well as the timing, outcome and potential for its offerings to impact patients’ ability to make timely treatment decisions, and the potential impact on clinical treatment and patient prognosis. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company\u2019s ability to successfully complete development of and to offer new types of tests, to execute on its strategic priorities and to otherwise implement its business plan, and the risks identified under the heading “Risk Factors” contained in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company’s other filings with the Securities and Exchange Commission.<\/p>\n

\nWe caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov<\/a> for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.<\/p>\n

Reference<\/b><\/p>\n

    \n
  1. \nAstraZeneca. Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer. News release. [AstraZeneca]; June 12, 2026. Accessed June 30, 2026.https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2026\/truqap-approved-in-us-for-prostate-cancer.html<\/a><\/li>\n
  2. \nZhang JY, Kong YY, Wang QF, et al. Prognostic value of PTEN in de novo diagnosed metastatic prostate cancer. Asian J Androl. 2022;24(1):50-55. doi:10.4103\/aja.aja_39_21<\/p>\n<\/li>\n
  3. \nStopsack KH, Nandakumar S, Wibmer AG, et al. Oncogenic genomic alterations, clinical phenotypes, and outcomes in metastatic castration-sensitive prostate cancer. Clin Cancer Res. 2020;26(13):3230-3238. doi:10.1158\/1078-0432.CCR-20-0168<\/p>\n<\/li>\n
  4. \nFizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016\/j.annonc.2025.10.004 [including the Supplementary Appendix]<\/p>\n<\/li>\n<\/ol>\n

    \n\u00a0<\/p>\n

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    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260709775177\/en\/<\/a><\/span><\/p>\n

    Media Contact
    \n<\/b>
    Andrea Sampson
    \n
    asampson@sampsonprgroup.com<\/a><\/p>\n

    Investor Contact
    \n<\/b>
    InvestorRelations@neogenomics.com<\/a><\/p>\n

    KEYWORDS:<\/b> United States North America Florida<\/p>\n

    INDUSTRY KEYWORDS:<\/b> Research Hospitals FDA Clinical Trials Practice Management Biotechnology Pharmaceutical Health Science Oncology<\/p>\n

    MEDIA:<\/b><\/p>\n\n\n\n\n
    Logo<\/b><\/font><\/td>\n<\/tr>\n
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    NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer Available within NEO PanTracer\u2122 Pro for prostate cancer and as a standalone test, PTEN IHC CDx identifies patients who may be eligible for TRUQAP\u00ae FORT MYERS, Fla.–(BUSINESS WIRE)–NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca\u2019s recently approved targeted therapy TRUQAP\u00ae (capivasertib).1 PTEN IHC CDx extends the company’s reach into urologic oncology, where community practices manage … <\/p>\n

    Continue reading “NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-980051","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nNeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer Available within NEO PanTracer\u2122 Pro for prostate cancer and as a standalone test, PTEN IHC CDx identifies patients who may be eligible for TRUQAP\u00ae FORT MYERS, Fla.–(BUSINESS WIRE)–NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca\u2019s recently approved targeted therapy TRUQAP\u00ae (capivasertib).1 PTEN IHC CDx extends the company’s reach into urologic oncology, where community practices manage … Continue reading "NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-09T11:08:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260709775177r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer\",\"datePublished\":\"2026-07-09T11:08:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/\"},\"wordCount\":1010,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20260709775177r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\\\/\",\"name\":\"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer - 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(NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca\u2019s recently approved targeted therapy TRUQAP\u00ae (capivasertib).1 PTEN IHC CDx extends the company’s reach into urologic oncology, where community practices manage … Continue reading \"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/","og_site_name":"Market Newsdesk","article_published_time":"2026-07-09T11:08:09+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260709775177r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer","datePublished":"2026-07-09T11:08:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/"},"wordCount":1010,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260709775177r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/neogenomics-launches-fda-approved-pten-ihc-companion-diagnostic-for-prostate-cancer\/","name":"NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer - 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