{"success":true,"data":{"pressRelease":{"id":"162026","rtpr_id":"nBw5jHM4ra-20261006","ticker":"BIAF","exchange":"NASDAQ","all_tickers":["BIAF","BIAFW"],"title":"bioAffinity Technologies Reports Over 100% Growth in CyPath® Lung Sales Through Third Quarter 2026","author":"Business Wire","published_at":"2026-10-06T13:19:00.097Z","article_body":"bioAffinity Technologies Reports Over 100% Growth in CyPath® Lung Sales\nThrough Third Quarter 2026\n\nNearly 90% increase in number of physician offices using CyPath Lung\n\nUtilization expands as physicians who ordered CyPath Lung in 2025 increase\nusage by nearly 50%\n\nbioAffinity Technologies, Inc.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bioaffinitytech.com&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=bioAffinity+Technologies%2C+Inc.&index=1&md5=d5521d8ef308ae12d28c91508774eb38)\n(Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive\nhealthcare solutions for the early detection and monitoring of lung disease,\ntoday announced that sales of its CyPath® Lung test for lung cancer increased\nmore than 100% through the third quarter of 2026 compared to 2025, reflecting\ncontinued growth in clinical adoption of the Company’s noninvasive test for\nassessing the likelihood of lung cancer in high-risk individuals.\n\nThe number of ordering physicians increased by 89% in Q3 2026 compared to Q3\n2025. Physicians who ordered CyPath Lung through Q3 2025 continued to expand\nutilization of the test, with sales volume increasing by 48% year-over-year.\nTesting through Q3 2026 resulted in more than 1620 tests delivered as compared\nto 775 tests through Q3 2025.\n\n\"One of our objectives for 2026 is executing on our strategy to expand access\nand drive adoption of CyPath Lung with physicians who have used our test over\ntime. We believe that sales of CyPath Lung in the third quarter of this year\ndemonstrate the ongoing success of our efforts,\" said Maria Zannes, President\nand CEO of bioAffinity Technologies. \"The 100% increase in third-quarter sales\nreflects growing utilization of CyPath Lung in pulmonology and oncology\npractices, lung nodule clinics and community medical centers. As we continue\nto increase our marketing efforts, we believe we are well positioned to pursue\nsimilar results generated by a larger base of physician prescribers. We are\nespecially focused on executing our new distribution agreement with\nVeteran-Owned AvMEDICAL, which we believe could help broaden our reach in the\ngovernment healthcare system, including the Department of Veterans Affairs.\"\n\nThe number of patients identified with indeterminate pulmonary nodules\ncontinues to rise, driven in part by increases in incidental findings and\nscreening by low-dose CT for high-risk patients. CyPath Lung’s flow\ncytometry+AI technology provides actionable information to support clinical\ndecision-making. The test result is intended to be used in conjunction with\nother clinical information, including imaging, medical history, risk factors\nand clinical guidelines.\n\n\"As clinicians, we are happy to see more eligible patients undergoing the\nrecommended lung cancer screening. But as more nodules are identified by\nimaging, physicians increasingly need more information to help determine the\nappropriate next steps for individual patients,\" said Gordon Downie, MD, PhD,\nChief Medical Officer of bioAffinity Technologies. \"CyPath Lung is designed to\nhelp fill that need by providing a result indicating either likely or unlikely\nmalignancy in the lung, which can be considered alongside imaging, clinical\nhistory and other findings to help determine whether a patient is most likely\nto benefit from additional monitoring, further diagnostic evaluation or an\ninvasive procedure.”\n\nAbout CyPath Lung\n\nCyPath Lung by bioAffinity Technologies is a noninvasive test designed to\nimprove the early detection of lung cancer in patients at high risk for the\ndisease. CyPath Lung uses advanced flow cytometry and proprietary artificial\nintelligence (AI) to identify cell populations in patient sputum that indicate\nmalignancy. CyPath Lung incorporates a novel fluorescent porphyrin that is\npreferentially taken up by cancer and cancer-related cells. In a published\nclinical trial\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Flink.springer.com%2Farticle%2F10.1186%2Fs12931-023-02327-3&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=published+clinical+trial&index=2&md5=4db11eb7c3e345cb8c1f74ca481dd239)\nof high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87%\nspecificity, 88% accuracy and 99% negative predictive value (NPV) in detecting\nlung cancer in patients at high risk for the disease who had small\nindeterminate lung nodules less than 20 millimeters. The high NPV may help\ninform physician decision-making when evaluating whether further invasive\nprocedures are warranted. CyPath Lung is marketed as a Laboratory Developed\nTest (LDT) and is not intended for use as a sole diagnostic tool and should be\nconsidered alongside other clinical findings. www.cypathlung.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cypathlung.com%2F&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=www.cypathlung.com&index=3&md5=7429cc2cef872d090a26aee4f48483a9)\n\nAbout bioAffinity Technologies, Inc.\n\nbioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of\nearly-stage cancer and other diseases of the lung and broad-spectrum cancer\ntreatments. The Company’s first product, CyPath Lung, is a noninvasive test\nthat has shown high sensitivity, specificity and accuracy for the detection of\nearly-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed\nTest (LDT) by Precision Pathology Laboratory Services, a subsidiary of\nbioAffinity Technologies. LDTs are overseen under the Clinical Laboratory\nImprovement Amendments (CLIA), which are administered by the Centers for\nMedicare & Medicaid Services. For more information, visit\nwww.bioaffinitytech.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bioaffinitytech.com&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=www.bioaffinitytech.com&index=4&md5=911eda9c9b39fdf7b1a959f411edf550)\n.\n\nForward-Looking Statements\n\nCertain statements in this press release constitute \"forward-looking\nstatements\" within the meaning of the federal securities laws. Words such as\n\"may,\" \"might,\" \"will,\" \"should,\" \"believe,\" \"expect,\" \"anticipate,\"\n\"estimate,\" \"continue,\" \"predict,\" \"forecast,\" \"project,\" \"plan,\" \"intend\" or\nsimilar expressions, or statements regarding intent, belief, or current\nexpectations, are forward-looking statements. These forward-looking statements\nare subject to various risks and uncertainties, many of which are difficult to\npredict, that could cause actual results to differ materially from current\nexpectations and assumptions from those set forth or implied by any\nforward-looking statements. Forward-looking statements in this press release\ninclude, but are not limited to, statements regarding the Company's\nexpectations of continued growth in sales, physician adoption or utilization\nof CyPath Lung; the anticipated benefits of the distribution agreement and\ncollaboration with AvMEDICAL, including expected expansion of government and\nagency access to and adoption of CyPath Lung, and expectations regarding\ngrowth in demand for, or use of, CyPath Lung moving forward; the Company's\nability to maintain and expand adoption of CyPath Lung as a Laboratory\nDeveloped Test, including compliance with evolving CLIA and FDA regulatory\nrequirements applicable to laboratory developed tests; the Company's need for\nadditional capital and ability to obtain financing on acceptable terms, or at\nall; competition from other diagnostic technologies and companies; and other\nfactors discussed in the Company’s Annual Report on Form 10-K for the year\nended December 31, 2025, and its subsequent filings with the SEC, including\nsubsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking\nstatements are based on facts and conditions as they exist at the time such\nstatements are made and predictions as to future facts and conditions. While\nthe Company believes these forward-looking statements are reasonable, readers\nof this press release are cautioned not to place undue reliance on any\nforward-looking statements. The information in this release is provided only\nas of the date of this release, and the Company does not undertake any\nobligation to update any forward-looking statement relating to matters\ndiscussed in this press release, except as may be required by applicable\nsecurities laws.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261006386482/en/\n(https://www.businesswire.com/news/home/20261006386482/en/)\n\nbioAffinity Technologies\n\nJulie Anne Overton\n\nDirector of Communications\n\ninvestors@bioaffinitytech.com (mailto:investors@bioaffinitytech.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw5jHM4ra-20261006","title":"bioAffinity Technologies Reports Over 100% Growth in CyPath® Lung Sales Through Third Quarter 2026","author":"Business Wire","ticker":"BIAF","created":"2026-10-06T13:19:00.097Z","tickers":["BIAF","BIAFW"],"exchange":"NASDAQ","article_body":"bioAffinity Technologies Reports Over 100% Growth in CyPath® Lung Sales\nThrough Third Quarter 2026\n\nNearly 90% increase in number of physician offices using CyPath Lung\n\nUtilization expands as physicians who ordered CyPath Lung in 2025 increase\nusage by nearly 50%\n\nbioAffinity Technologies, Inc.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bioaffinitytech.com&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=bioAffinity+Technologies%2C+Inc.&index=1&md5=d5521d8ef308ae12d28c91508774eb38)\n(Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive\nhealthcare solutions for the early detection and monitoring of lung disease,\ntoday announced that sales of its CyPath® Lung test for lung cancer increased\nmore than 100% through the third quarter of 2026 compared to 2025, reflecting\ncontinued growth in clinical adoption of the Company’s noninvasive test for\nassessing the likelihood of lung cancer in high-risk individuals.\n\nThe number of ordering physicians increased by 89% in Q3 2026 compared to Q3\n2025. Physicians who ordered CyPath Lung through Q3 2025 continued to expand\nutilization of the test, with sales volume increasing by 48% year-over-year.\nTesting through Q3 2026 resulted in more than 1620 tests delivered as compared\nto 775 tests through Q3 2025.\n\n\"One of our objectives for 2026 is executing on our strategy to expand access\nand drive adoption of CyPath Lung with physicians who have used our test over\ntime. We believe that sales of CyPath Lung in the third quarter of this year\ndemonstrate the ongoing success of our efforts,\" said Maria Zannes, President\nand CEO of bioAffinity Technologies. \"The 100% increase in third-quarter sales\nreflects growing utilization of CyPath Lung in pulmonology and oncology\npractices, lung nodule clinics and community medical centers. As we continue\nto increase our marketing efforts, we believe we are well positioned to pursue\nsimilar results generated by a larger base of physician prescribers. We are\nespecially focused on executing our new distribution agreement with\nVeteran-Owned AvMEDICAL, which we believe could help broaden our reach in the\ngovernment healthcare system, including the Department of Veterans Affairs.\"\n\nThe number of patients identified with indeterminate pulmonary nodules\ncontinues to rise, driven in part by increases in incidental findings and\nscreening by low-dose CT for high-risk patients. CyPath Lung’s flow\ncytometry+AI technology provides actionable information to support clinical\ndecision-making. The test result is intended to be used in conjunction with\nother clinical information, including imaging, medical history, risk factors\nand clinical guidelines.\n\n\"As clinicians, we are happy to see more eligible patients undergoing the\nrecommended lung cancer screening. But as more nodules are identified by\nimaging, physicians increasingly need more information to help determine the\nappropriate next steps for individual patients,\" said Gordon Downie, MD, PhD,\nChief Medical Officer of bioAffinity Technologies. \"CyPath Lung is designed to\nhelp fill that need by providing a result indicating either likely or unlikely\nmalignancy in the lung, which can be considered alongside imaging, clinical\nhistory and other findings to help determine whether a patient is most likely\nto benefit from additional monitoring, further diagnostic evaluation or an\ninvasive procedure.”\n\nAbout CyPath Lung\n\nCyPath Lung by bioAffinity Technologies is a noninvasive test designed to\nimprove the early detection of lung cancer in patients at high risk for the\ndisease. CyPath Lung uses advanced flow cytometry and proprietary artificial\nintelligence (AI) to identify cell populations in patient sputum that indicate\nmalignancy. CyPath Lung incorporates a novel fluorescent porphyrin that is\npreferentially taken up by cancer and cancer-related cells. In a published\nclinical trial\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Flink.springer.com%2Farticle%2F10.1186%2Fs12931-023-02327-3&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=published+clinical+trial&index=2&md5=4db11eb7c3e345cb8c1f74ca481dd239)\nof high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87%\nspecificity, 88% accuracy and 99% negative predictive value (NPV) in detecting\nlung cancer in patients at high risk for the disease who had small\nindeterminate lung nodules less than 20 millimeters. The high NPV may help\ninform physician decision-making when evaluating whether further invasive\nprocedures are warranted. CyPath Lung is marketed as a Laboratory Developed\nTest (LDT) and is not intended for use as a sole diagnostic tool and should be\nconsidered alongside other clinical findings. www.cypathlung.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cypathlung.com%2F&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=www.cypathlung.com&index=3&md5=7429cc2cef872d090a26aee4f48483a9)\n\nAbout bioAffinity Technologies, Inc.\n\nbioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of\nearly-stage cancer and other diseases of the lung and broad-spectrum cancer\ntreatments. The Company’s first product, CyPath Lung, is a noninvasive test\nthat has shown high sensitivity, specificity and accuracy for the detection of\nearly-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed\nTest (LDT) by Precision Pathology Laboratory Services, a subsidiary of\nbioAffinity Technologies. LDTs are overseen under the Clinical Laboratory\nImprovement Amendments (CLIA), which are administered by the Centers for\nMedicare & Medicaid Services. For more information, visit\nwww.bioaffinitytech.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bioaffinitytech.com&esheet=54616840&newsitemid=20261006386482&lan=en-US&anchor=www.bioaffinitytech.com&index=4&md5=911eda9c9b39fdf7b1a959f411edf550)\n.\n\nForward-Looking Statements\n\nCertain statements in this press release constitute \"forward-looking\nstatements\" within the meaning of the federal securities laws. Words such as\n\"may,\" \"might,\" \"will,\" \"should,\" \"believe,\" \"expect,\" \"anticipate,\"\n\"estimate,\" \"continue,\" \"predict,\" \"forecast,\" \"project,\" \"plan,\" \"intend\" or\nsimilar expressions, or statements regarding intent, belief, or current\nexpectations, are forward-looking statements. These forward-looking statements\nare subject to various risks and uncertainties, many of which are difficult to\npredict, that could cause actual results to differ materially from current\nexpectations and assumptions from those set forth or implied by any\nforward-looking statements. Forward-looking statements in this press release\ninclude, but are not limited to, statements regarding the Company's\nexpectations of continued growth in sales, physician adoption or utilization\nof CyPath Lung; the anticipated benefits of the distribution agreement and\ncollaboration with AvMEDICAL, including expected expansion of government and\nagency access to and adoption of CyPath Lung, and expectations regarding\ngrowth in demand for, or use of, CyPath Lung moving forward; the Company's\nability to maintain and expand adoption of CyPath Lung as a Laboratory\nDeveloped Test, including compliance with evolving CLIA and FDA regulatory\nrequirements applicable to laboratory developed tests; the Company's need for\nadditional capital and ability to obtain financing on acceptable terms, or at\nall; competition from other diagnostic technologies and companies; and other\nfactors discussed in the Company’s Annual Report on Form 10-K for the year\nended December 31, 2025, and its subsequent filings with the SEC, including\nsubsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking\nstatements are based on facts and conditions as they exist at the time such\nstatements are made and predictions as to future facts and conditions. While\nthe Company believes these forward-looking statements are reasonable, readers\nof this press release are cautioned not to place undue reliance on any\nforward-looking statements. The information in this release is provided only\nas of the date of this release, and the Company does not undertake any\nobligation to update any forward-looking statement relating to matters\ndiscussed in this press release, except as may be required by applicable\nsecurities laws.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261006386482/en/\n(https://www.businesswire.com/news/home/20261006386482/en/)\n\nbioAffinity Technologies\n\nJulie Anne Overton\n\nDirector of Communications\n\ninvestors@bioaffinitytech.com (mailto:investors@bioaffinitytech.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-06T13:19:00.133654523Z","server_sent_at_ms":1791292740133},"received_at":"2026-10-06T13:19:00.185Z","source_url":"https://www.businesswire.com/news/home/20261006386482/en/"},"analysis":{"id":"150528","press_release_id":"162026","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["sales growth disclosed without revenue dollars, making absolute commercial scale hard to assess","company notes need for additional capital in forward-looking statements","CyPath Lung is an LDT subject to evolving FDA regulatory requirements for laboratory developed tests"],"eventType":"operations_update","narrative":"bioAffinity Technologies reported that CyPath Lung sales rose more than 100% through Q3 2026 versus the prior year, with tests delivered climbing to over 1,620 from 775 through Q3 2025.\n\nThe number of ordering physicians grew 89% year-over-year, while physicians who adopted the test in 2025 increased their utilization by 48%, pointing to both new adoption and deepening repeat usage.\n\nManagement highlighted a new distribution agreement with Veteran-Owned AvMEDICAL aimed at broadening reach in the government healthcare system, including the Department of Veterans Affairs.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"CyPath Lung adoption doubles with 89% physician growth — new VA-focused AvMEDICAL distribution deal could be the next leg."},"keyFigures":{"customDimensions":{"sales_growth_yoy":"more than 100%","tests_delivered_q3_2025":775,"tests_delivered_q3_2026":1620,"physician_offices_growth":"nearly 90%","ordering_physicians_growth_q3":"89%","existing_physician_usage_growth":"48%"}},"quotedText":"The 100% increase in third-quarter sales reflects growing utilization of CyPath Lung in pulmonology and oncology practices, lung nodule clinics and community medical centers.","namedEntities":{"people":[{"name":"Maria Zannes","role":"President and CEO"},{"name":"Gordon Downie","role":"Chief Medical Officer"},{"name":"Julie Anne Overton","role":"Director of Communications"}],"products":["CyPath Lung"],"companies":[{"name":"bioAffinity Technologies, Inc.","ticker":"BIAF","relationship":"filer"},{"name":"AvMEDICAL","relationship":"distribution partner"},{"name":"Precision Pathology Laboratory Services","relationship":"subsidiary"},{"name":"Department of Veterans Affairs","relationship":"potential government customer"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Over 100% growth in CyPath Lung sales and an 89% increase in ordering physicians is a material commercial-adoption milestone for a small-cap diagnostics company, but no revenue dollars are disclosed and it is a pre-earnings operational update."},"tickerRelevance":{"others":[],"primary":"BIAF"},"globalImportance":22,"audienceRelevance":20,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"commercial adoption update without financials","sectorWeight":"diagnostics/biotech","retailFavoriteBoost":false}},"event_type":"operations_update","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"bioAffinity Technologies reported that CyPath Lung sales rose more than 100% through Q3 2026 versus the prior year, with tests delivered climbing to over 1,620 from 775 through Q3 2025.\n\nThe number of ordering physicians grew 89% year-over-year, while physicians who adopted the test in 2025 increased their utilization by 48%, pointing to both new adoption and deepening repeat usage.\n\nManagement highlighted a new distribution agreement with Veteran-Owned AvMEDICAL aimed at broadening reach in the government healthcare system, including the Department of Veterans Affairs.","key_figures":{"customDimensions":{"sales_growth_yoy":"more than 100%","tests_delivered_q3_2025":775,"tests_delivered_q3_2026":1620,"physician_offices_growth":"nearly 90%","ordering_physicians_growth_q3":"89%","existing_physician_usage_growth":"48%"}},"named_entities":{"people":[{"name":"Maria Zannes","role":"President and CEO"},{"name":"Gordon Downie","role":"Chief Medical Officer"},{"name":"Julie Anne Overton","role":"Director of Communications"}],"products":["CyPath Lung"],"companies":[{"name":"bioAffinity Technologies, Inc.","ticker":"BIAF","relationship":"filer"},{"name":"AvMEDICAL","relationship":"distribution partner"},{"name":"Precision Pathology Laboratory Services","relationship":"subsidiary"},{"name":"Department of Veterans Affairs","relationship":"potential government customer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-06T13:19:06.172Z","global_importance":22,"audience_relevance":20,"importance_components":{"tickerTier":"micro-cap","eventGravity":"commercial adoption update without financials","sectorWeight":"diagnostics/biotech","retailFavoriteBoost":false}},"durationMs":5944,"modelName":"glm-5.3-flashx"}}