{"success":true,"data":{"pressRelease":{"id":"168828","rtpr_id":"nGNX3t2rj1-20261014","ticker":"IMDX","exchange":"NASDAQ","all_tickers":["IMDX"],"title":"iMDx Welcomes New Diagnostics Sales Leader to Prepare for Planned GraftAssureDx Launch","author":"Globe Newswire","published_at":"2026-10-14T12:00:02.277Z","article_body":"NASHVILLE, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics\nInc., (Nasdaq: IMDX), (iMDx), today announced the appointment of Donnie Purto\nas Senior Vice President of Sales to lead the company’s commercialization\nefforts as it prepares to bring GraftAssureDx to market. GraftAssureDx is\ncurrently under FDA medical device review and is awaiting regulatory\nauthorization.\n\nMr. Purto is an accomplished sales leader with more than 20 years of\nexperience building and leading high-performing sales organizations across\ndiagnostics, life sciences and healthcare. During a decade at Natera, Inc., he\nhad success in leadership roles spanning sales, training, oncology, transplant\nand women’s health. Responsibilities included new product launches as well\nas managing hundreds of millions of dollars in revenue in highly competitive\nmarkets.\n\n“We are excited to have Donnie take the reins of our commercial organization\nas we prepare to advance our goal of disrupting transplanted organ health\ntesting in 2027,” said iMDx CEO Josh Riggs. “His ability to drive sales of\nproducts, which are based on innovative science, into positions of market\nleadership is exactly what we need in this next phase as we ready for a\nproduct launch. He has already established a track record in the transplant\ncommunity, and we look forward to benefiting from his expertise.”\n\nNewly appointed SVP Sales Donnie Purto said, “I'm excited to join iMDx at\nsuch a pivotal moment for the company. Our commercial team has already built\nstrong relationships with many of the highest volume kidney transplant centers\nin the country, including Cleveland Clinic, Tampa General Hospital, Mayo\nClinic, Vanderbilt University and others, which were involved in the FDA\nsubmission for GraftAssureDx. That foundation gives us a head start as we\nprepare for a commercial launch pending FDA authorization.”\n\niMDx Transplant Products and Product Candidates in Development\n\niMDx’s flagship transplant testing technology quantifies a molecular\nbiomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s\nscientists in Germany and the U.S. have played a critical role over the past\ndecade in developing the science that helped establish dd-cfDNA as a trusted\nbiomarker of transplant rejection. iMDx is commercializing this technology\nusing a market-disruptive business strategy. Under the GraftAssure™ brand,\niMDx’s transplant diagnostics include the following:\n* GraftAssureCore – The company’s laboratory-developed test (LDT),\ncurrently reimbursed by CMS and performed at iMDx’s CLIA-certified\nlaboratory in Franklin, Tennessee.\n* GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for\nnon-clinical applications.\n* GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA\nreview for use in clinical decision-making.\nAbout Insight Molecular Diagnostics Inc.\n\nInsight Molecular Diagnostics is a pioneering diagnostics technology company\nwhose mission is to democratize access to novel molecular diagnostic testing\nto improve patient outcomes. Investors may visit\nhttps://investors.imdxinc.com/ for more information.\n\nGraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™,\nGraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight\nMolecular Diagnostics Inc.\n\nForward-Looking Statements\n\nAny statements that are not historical fact (including, but not limited to,\nstatements that contain words such as “will,” “believes,” “plans,”\n“anticipates,” “expects,” “estimates,” “may,” and similar\nexpressions) are forward-looking statements. These statements include those\npertaining to, among other things, the company’s efforts to commercialize\nits GraftAssure technology, expected FDA marketing authorization and\ncommercial launch of GraftAssureDx, Mr. Purto’s expected contributions to\nthe company, transplant and other product candidates in development, and other\nstatements about the future expectations, beliefs, goals, plans, or prospects\nexpressed by management.\n\nForward-looking statements involve risks and uncertainties, including, without\nlimitation, risks inherent in the development and/or commercialization of\ndiagnostic tests or products, uncertainty in the results of clinical trials or\nregulatory approvals, the capacity of Insight Molecular Diagnostics’\nthird-party supplied blood sample analytic system to provide consistent and\nprecise analytic results on a commercial scale, potential interruptions to\nsupply chains, the need and ability to obtain future capital, maintenance of\nintellectual property rights in all applicable jurisdictions, obligations to\nthird parties with respect to licensed or acquired technology and products,\nthe need to obtain third party reimbursement for patients’ use of any\ndiagnostic tests Insight Molecular Diagnostics or its subsidiaries\ncommercialize in applicable jurisdictions, and risks inherent in strategic\ntransactions such as the potential failure to realize anticipated benefits,\nlegal, regulatory or political changes in the applicable jurisdictions,\naccounting and quality controls, potential greater than estimated allocations\nof resources to develop and commercialize technologies, or potential failure\nto maintain any laboratory accreditation or certification. Actual results may\ndiffer materially from the results anticipated in these forward-looking\nstatements and accordingly such statements should be evaluated together with\nthe many uncertainties that affect the business of Insight Molecular\nDiagnostics, particularly those mentioned in the “Risk Factors” and other\ncautionary statements found in Insight Molecular Diagnostics’ Securities and\nExchange Commission (SEC) filings, which are available from the SEC’s\nwebsite. You are cautioned not to place undue reliance on forward-looking\nstatements, which speak only as of the date on which they were made. Insight\nMolecular Diagnostics undertakes no obligation to update such statements to\nreflect events that occur or circumstances that exist after the date on which\nthey were made, except as required by law.  \n\nFDA\n\nCAUTION: This press release concerns certain products that are under clinical\ninvestigation, and which have not yet been cleared or authorized for marketing\nby the U.S. Food and Drug Administration. These products are currently limited\nby federal law to investigational use, and no representation is made as to the\nsafety or effectiveness of these products for the purposes for which they are\nbeing investigated.\n\nInvestor Contact: \nAlexandra Grossman\nLifeSci Advisors LLC \nimdx@lifesciadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/418fe8d1-a6a4-4025-84ba-56f14ee83865)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3t2rj1-20261014","title":"iMDx Welcomes New Diagnostics Sales Leader to Prepare for Planned GraftAssureDx Launch","author":"Globe Newswire","ticker":"IMDX","created":"2026-10-14T12:00:02.277Z","tickers":["IMDX"],"exchange":"NASDAQ","article_body":"NASHVILLE, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics\nInc., (Nasdaq: IMDX), (iMDx), today announced the appointment of Donnie Purto\nas Senior Vice President of Sales to lead the company’s commercialization\nefforts as it prepares to bring GraftAssureDx to market. GraftAssureDx is\ncurrently under FDA medical device review and is awaiting regulatory\nauthorization.\n\nMr. Purto is an accomplished sales leader with more than 20 years of\nexperience building and leading high-performing sales organizations across\ndiagnostics, life sciences and healthcare. During a decade at Natera, Inc., he\nhad success in leadership roles spanning sales, training, oncology, transplant\nand women’s health. Responsibilities included new product launches as well\nas managing hundreds of millions of dollars in revenue in highly competitive\nmarkets.\n\n“We are excited to have Donnie take the reins of our commercial organization\nas we prepare to advance our goal of disrupting transplanted organ health\ntesting in 2027,” said iMDx CEO Josh Riggs. “His ability to drive sales of\nproducts, which are based on innovative science, into positions of market\nleadership is exactly what we need in this next phase as we ready for a\nproduct launch. He has already established a track record in the transplant\ncommunity, and we look forward to benefiting from his expertise.”\n\nNewly appointed SVP Sales Donnie Purto said, “I'm excited to join iMDx at\nsuch a pivotal moment for the company. Our commercial team has already built\nstrong relationships with many of the highest volume kidney transplant centers\nin the country, including Cleveland Clinic, Tampa General Hospital, Mayo\nClinic, Vanderbilt University and others, which were involved in the FDA\nsubmission for GraftAssureDx. That foundation gives us a head start as we\nprepare for a commercial launch pending FDA authorization.”\n\niMDx Transplant Products and Product Candidates in Development\n\niMDx’s flagship transplant testing technology quantifies a molecular\nbiomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s\nscientists in Germany and the U.S. have played a critical role over the past\ndecade in developing the science that helped establish dd-cfDNA as a trusted\nbiomarker of transplant rejection. iMDx is commercializing this technology\nusing a market-disruptive business strategy. Under the GraftAssure™ brand,\niMDx’s transplant diagnostics include the following:\n* GraftAssureCore – The company’s laboratory-developed test (LDT),\ncurrently reimbursed by CMS and performed at iMDx’s CLIA-certified\nlaboratory in Franklin, Tennessee.\n* GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for\nnon-clinical applications.\n* GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA\nreview for use in clinical decision-making.\nAbout Insight Molecular Diagnostics Inc.\n\nInsight Molecular Diagnostics is a pioneering diagnostics technology company\nwhose mission is to democratize access to novel molecular diagnostic testing\nto improve patient outcomes. Investors may visit\nhttps://investors.imdxinc.com/ for more information.\n\nGraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™,\nGraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight\nMolecular Diagnostics Inc.\n\nForward-Looking Statements\n\nAny statements that are not historical fact (including, but not limited to,\nstatements that contain words such as “will,” “believes,” “plans,”\n“anticipates,” “expects,” “estimates,” “may,” and similar\nexpressions) are forward-looking statements. These statements include those\npertaining to, among other things, the company’s efforts to commercialize\nits GraftAssure technology, expected FDA marketing authorization and\ncommercial launch of GraftAssureDx, Mr. Purto’s expected contributions to\nthe company, transplant and other product candidates in development, and other\nstatements about the future expectations, beliefs, goals, plans, or prospects\nexpressed by management.\n\nForward-looking statements involve risks and uncertainties, including, without\nlimitation, risks inherent in the development and/or commercialization of\ndiagnostic tests or products, uncertainty in the results of clinical trials or\nregulatory approvals, the capacity of Insight Molecular Diagnostics’\nthird-party supplied blood sample analytic system to provide consistent and\nprecise analytic results on a commercial scale, potential interruptions to\nsupply chains, the need and ability to obtain future capital, maintenance of\nintellectual property rights in all applicable jurisdictions, obligations to\nthird parties with respect to licensed or acquired technology and products,\nthe need to obtain third party reimbursement for patients’ use of any\ndiagnostic tests Insight Molecular Diagnostics or its subsidiaries\ncommercialize in applicable jurisdictions, and risks inherent in strategic\ntransactions such as the potential failure to realize anticipated benefits,\nlegal, regulatory or political changes in the applicable jurisdictions,\naccounting and quality controls, potential greater than estimated allocations\nof resources to develop and commercialize technologies, or potential failure\nto maintain any laboratory accreditation or certification. Actual results may\ndiffer materially from the results anticipated in these forward-looking\nstatements and accordingly such statements should be evaluated together with\nthe many uncertainties that affect the business of Insight Molecular\nDiagnostics, particularly those mentioned in the “Risk Factors” and other\ncautionary statements found in Insight Molecular Diagnostics’ Securities and\nExchange Commission (SEC) filings, which are available from the SEC’s\nwebsite. You are cautioned not to place undue reliance on forward-looking\nstatements, which speak only as of the date on which they were made. Insight\nMolecular Diagnostics undertakes no obligation to update such statements to\nreflect events that occur or circumstances that exist after the date on which\nthey were made, except as required by law.  \n\nFDA\n\nCAUTION: This press release concerns certain products that are under clinical\ninvestigation, and which have not yet been cleared or authorized for marketing\nby the U.S. Food and Drug Administration. These products are currently limited\nby federal law to investigational use, and no representation is made as to the\nsafety or effectiveness of these products for the purposes for which they are\nbeing investigated.\n\nInvestor Contact: \nAlexandra Grossman\nLifeSci Advisors LLC \nimdx@lifesciadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/418fe8d1-a6a4-4025-84ba-56f14ee83865)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-14T12:00:03.005739543Z","server_sent_at_ms":1791979203005},"received_at":"2026-10-14T12:00:03.056Z","source_url":null},"analysis":{"id":"157082","press_release_id":"168828","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["GraftAssureDx launch contingent on pending FDA authorization — regulatory risk remains"],"eventType":"executive_change","narrative":"Insight Molecular Diagnostics appointed Donnie Purto as SVP of Sales to lead commercialization of GraftAssureDx, which is currently under FDA medical device review.\n\nPurto brings 20+ years of diagnostics sales leadership, including a decade at Natera spanning transplant and oncology launches.\n\nCEO Josh Riggs framed the hire as launch preparation to disrupt transplanted organ health testing in 2027, with key kidney transplant centers like Cleveland Clinic and Mayo Clinic already engaged from the FDA submission.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Commercial build-out ahead of GraftAssureDx launch — watch FDA authorization as the real catalyst."},"keyFigures":{"drugName":"GraftAssureDx","customDimensions":{"natera_tenure":"decade","purto_years_experience":"20+"}},"quotedText":"We are excited to have Donnie take the reins of our commercial organization as we prepare to advance our goal of disrupting transplanted organ health testing in 2027","namedEntities":{"people":[{"name":"Donnie Purto","role":"SVP of Sales (newly appointed)"},{"name":"Josh Riggs","role":"CEO"}],"products":["GraftAssureDx","GraftAssureCore","GraftAssureIQ","GraftAssure","VitaGraft","DetermaIO","DetermaCNI"],"companies":[{"name":"Insight Molecular Diagnostics Inc.","ticker":"IMDX","relationship":"filer"},{"name":"Natera, Inc.","relationship":"new hire's prior employer"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Appointment of a commercial SVP ahead of a planned launch is a routine, non-C-suite executive hire. Positive signal for launch readiness, but no CEO departure or material financial event."},"tickerRelevance":{"others":[],"primary":"IMDX"},"globalImportance":18,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","fdaOverhang":true,"eventGravity":"routine-executive-hire","launchReadinessSignal":true}},"event_type":"executive_change","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Insight Molecular Diagnostics appointed Donnie Purto as SVP of Sales to lead commercialization of GraftAssureDx, which is currently under FDA medical device review.\n\nPurto brings 20+ years of diagnostics sales leadership, including a decade at Natera spanning transplant and oncology launches.\n\nCEO Josh Riggs framed the hire as launch preparation to disrupt transplanted organ health testing in 2027, with key kidney transplant centers like Cleveland Clinic and Mayo Clinic already engaged from the FDA submission.","key_figures":{"drugName":"GraftAssureDx","customDimensions":{"natera_tenure":"decade","purto_years_experience":"20+"}},"named_entities":{"people":[{"name":"Donnie Purto","role":"SVP of Sales (newly appointed)"},{"name":"Josh Riggs","role":"CEO"}],"products":["GraftAssureDx","GraftAssureCore","GraftAssureIQ","GraftAssure","VitaGraft","DetermaIO","DetermaCNI"],"companies":[{"name":"Insight Molecular Diagnostics Inc.","ticker":"IMDX","relationship":"filer"},{"name":"Natera, Inc.","relationship":"new hire's prior employer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T12:00:25.277Z","global_importance":18,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap","fdaOverhang":true,"eventGravity":"routine-executive-hire","launchReadinessSignal":true}},"durationMs":4918,"modelName":"glm-5.3-flashx"}}