Latest news with #NeoGenomics'
Yahoo
22-05-2025
- Business
- Yahoo
NeoGenomics Launches c-MET CDx Assay to Guide Treatment Decisions for Advanced Non-Small Cell Lung Cancer
Validated companion diagnostic offers rapid results and supports eligible patient selection for newly approved targeted therapy FORT MYERS, Fla., May 22, 2025--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology testing services, today announced the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay. The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time. The c-MET CDx for NSCLC assay detects c-Met protein overexpression, a biomarker observed in up to 50% of patients with advanced NSCLC.¹ It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS™ (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA).* "Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient's treatment," said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. "The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer™ suite, enabling comprehensive biomarker profiling for NSCLC." Key features of NeoGenomics' assay include: Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated for use with MET-targeted therapies. Fast Turnaround: Delivers results within 48 hours to enable timely, informed clinical decisions. Validated Performance: Designed for use with tumor tissue samples to detect MET protein overexpression. Integrated NSCLC Offering: Complements NeoGenomics' broader PanTracer™ portfolio, including genomic and immuno-oncology markers. The c-MET CDx for NSCLC assay is now available as part of NeoGenomics' comprehensive NSCLC testing portfolio. Its addition supports the growing use of MET-directed therapies and reflects ongoing efforts to align diagnostic services with emerging standards in precision cancer care. For more information or to order the test, visit *EMRELIS™ (telisotuzumab vedotin-tllv) was approved by the U.S. FDA on May 14, 2025, for adults with previously treated advanced NSCLC with high c-MET protein overexpression. About NeoGenomics, Inc. 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 help them diagnose and treat cancer. 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 U.S. and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "plan," "potential" and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. 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's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and 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. We 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 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. References Camidge DR, Barlesi F, Goldman JW, et al. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023;41(5):1105-1115. doi:10.1200/JCO.22.00739 View source version on Contacts Investor Contact Kendra Media Contact Andrea Sampsonasampson@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
NeoGenomics Launches c-MET CDx Assay to Guide Treatment Decisions for Advanced Non-Small Cell Lung Cancer
Validated companion diagnostic offers rapid results and supports eligible patient selection for newly approved targeted therapy FORT MYERS, Fla., May 22, 2025--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology testing services, today announced the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay. The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time. The c-MET CDx for NSCLC assay detects c-Met protein overexpression, a biomarker observed in up to 50% of patients with advanced NSCLC.¹ It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS™ (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA).* "Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient's treatment," said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. "The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer™ suite, enabling comprehensive biomarker profiling for NSCLC." Key features of NeoGenomics' assay include: Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated for use with MET-targeted therapies. Fast Turnaround: Delivers results within 48 hours to enable timely, informed clinical decisions. Validated Performance: Designed for use with tumor tissue samples to detect MET protein overexpression. Integrated NSCLC Offering: Complements NeoGenomics' broader PanTracer™ portfolio, including genomic and immuno-oncology markers. The c-MET CDx for NSCLC assay is now available as part of NeoGenomics' comprehensive NSCLC testing portfolio. Its addition supports the growing use of MET-directed therapies and reflects ongoing efforts to align diagnostic services with emerging standards in precision cancer care. For more information or to order the test, visit *EMRELIS™ (telisotuzumab vedotin-tllv) was approved by the U.S. FDA on May 14, 2025, for adults with previously treated advanced NSCLC with high c-MET protein overexpression. About NeoGenomics, Inc. 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 help them diagnose and treat cancer. 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 U.S. and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "plan," "potential" and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. 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's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and 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. We 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 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. References Camidge DR, Barlesi F, Goldman JW, et al. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023;41(5):1105-1115. doi:10.1200/JCO.22.00739 View source version on Contacts Investor Contact Kendra Media Contact Andrea Sampsonasampson@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-05-2025
- Business
- Business Wire
NeoGenomics Launches c-MET CDx Assay to Guide Treatment Decisions for Advanced Non-Small Cell Lung Cancer
FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology testing services, today announced the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay. The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time. The c-MET CDx for NSCLC assay detects c-Met protein overexpression, a biomarker observed in up to 50% of patients with advanced NSCLC.¹ It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS™ (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA).* 'Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient's treatment,' said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. 'The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer™ suite, enabling comprehensive biomarker profiling for NSCLC.' Key features of NeoGenomics' assay include: Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated for use with MET-targeted therapies. Fast Turnaround: Delivers results within 48 hours to enable timely, informed clinical decisions. Validated Performance: Designed for use with tumor tissue samples to detect MET protein overexpression. Integrated NSCLC Offering: Complements NeoGenomics' broader PanTracer™ portfolio, including genomic and immuno-oncology markers. The c-MET CDx for NSCLC assay is now available as part of NeoGenomics' comprehensive NSCLC testing portfolio. Its addition supports the growing use of MET-directed therapies and reflects ongoing efforts to align diagnostic services with emerging standards in precision cancer care. For more information or to order the test, visit *EMRELIS™ (telisotuzumab vedotin-tllv) was approved by the U.S. FDA on May 14, 2025, for adults with previously treated advanced NSCLC with high c-MET protein overexpression. About NeoGenomics, Inc. 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 help them diagnose and treat cancer. 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 U.S. and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as 'anticipate,' 'expect,' 'plan,' 'could,' 'would,' 'may,' 'will,' 'believe,' 'estimate,' 'forecast,' 'goal,' 'project,' 'guidance,' 'plan,' 'potential' and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. 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's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and 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. We 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 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. References Camidge DR, Barlesi F, Goldman JW, et al. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol.
Yahoo
13-05-2025
- Business
- Yahoo
NEO Q1 Earnings Call: Sales Growth, Pharma Headwinds, and Pathline Integration Shape Outlook
Oncology (cancer) diagnostics company NeoGenomics (NASDAQ:NEO) fell short of the market's revenue expectations in Q1 CY2025, but sales rose 7.5% year on year to $168 million. On the other hand, the company's full-year revenue guidance of $753 million at the midpoint came in 2% above analysts' estimates. Its non-GAAP loss of $0 per share was in line with analysts' consensus estimates. Is now the time to buy NEO? Find out in our full research report (it's free). Revenue: $168 million vs analyst estimates of $170.9 million (7.5% year-on-year growth, 1.7% miss) Adjusted EPS: $0 vs analyst estimates of -$0.01 (in line) Adjusted EBITDA: $7.07 million vs analyst estimates of $5.27 million (4.2% margin, 34.3% beat) The company lifted its revenue guidance for the full year to $753 million at the midpoint from $740 million, a 1.8% increase EBITDA guidance for the full year is $56.5 million at the midpoint, above analyst estimates of $55.63 million Operating Margin: -16.6%, up from -19.6% in the same quarter last year Free Cash Flow was -$29.83 million compared to -$31.5 million in the same quarter last year Market Capitalization: $1.1 billion NeoGenomics' first quarter results reflected continued growth in clinical testing, particularly from its next-generation sequencing (NGS) portfolio and expanded commercial reach. Management attributed the increase in clinical test volumes and revenue per test to the successful launch of five new NGS products and targeted investments in its salesforce, as well as the recent acquisition of Pathline, which expands the company's Northeast presence. CEO Tony Zook emphasized that the company's strategy remains focused on serving community oncology providers, with new product launches and operational efficiencies supporting ongoing momentum. Looking ahead, leadership lifted full-year revenue guidance, underpinned by the expected benefits from Pathline, additional NGS product introductions, and commercial partnerships such as the collaboration with Adaptive for minimal residual disease (MRD) testing. Management also cautioned that macroeconomic pressures, including weaker pharma and biotech spending and non-clinical revenue headwinds, are likely to persist but will be offset by growth in the core clinical business. CFO Jeff Sherman reiterated NeoGenomics' commitment to financial discipline, stating, 'We will continue to take a balanced approach to investments with increasing adjusted EBITDA, enabling further investments to drive operating efficiencies in the business and targeted investments in R&D.' NeoGenomics' management highlighted several major factors shaping first quarter performance, with accelerating growth in clinical diagnostics and ongoing investment in new products and operational capabilities. NGS Segment Drives Growth: The launch of five new next-generation sequencing (NGS) tests accounted for 22% of total clinical revenue, reflecting strong adoption within community oncology practices. Management noted that deeper relationships with community hospitals are providing a competitive edge and driving higher-value test utilization. Pathline Acquisition Expands Market Reach: The recently closed acquisition of Pathline, a New York state-approved laboratory, establishes a physical presence in the Northeast and is expected to accelerate top-line growth by improving access to regional providers. Integration efforts are underway, with management expecting incremental clinical revenue contributions this year and greater earnings impact in 2026. Salesforce Expansion to Support Penetration: NeoGenomics completed the expansion of its commercial team to approximately 140 salespeople, aiming for near one-to-one coverage between hospital pathology and community oncology. Leadership sees this as critical to supporting upcoming product launches and deepening market penetration. Non-Clinical Revenue Pressure: The pharma and biotech segment, which comprises about 10% of total revenues, remains under pressure due to reduced research spending and macroeconomic factors such as tariffs and potential NIH funding cuts. Management acknowledged this headwind but maintained confidence in the long-term strategic value of the segment. Product Pipeline Highlights: Validation and early-access programs for PanTracer liquid biopsy, an NGS-based blood test, have generated strong interest from community oncologists. The company also highlighted a new partnership with Ultima Genomics for low-cost, high-quality sequencing and ongoing development of next-generation MRD technologies, aiming for product launches in the next two years. Management's outlook for the remainder of the year is anchored by the continued expansion of NGS offerings, Pathline integration, and the maturing salesforce, while acknowledging ongoing challenges in the non-clinical segment and industry-wide macro pressures. NGS and Product Launches: Future growth is expected to come from the commercial launch of PanTracer liquid biopsy and upgrades to the comprehensive NGS panel, along with increased adoption of MRD testing through the Adaptive partnership. Leadership anticipates these launches will drive higher test volumes and revenue per test. Pathline Integration Synergies: Successful integration of Pathline is expected to gradually enhance operating leverage and support incremental clinical revenue, with more substantial benefits projected for 2026 as NeoGenomics' full test menu becomes available to Pathline's customer base. Non-Clinical Revenue Headwinds: Management warned that continued softness in pharma and biotech spending, along with external factors such as tariffs and research funding uncertainty, could further weigh on non-clinical revenues in the near-term. The company expects core clinical growth to offset these headwinds but highlighted this as a key risk. Andrew Brackman (William Blair): Asked CEO Tony Zook about any early surprises since taking the helm and whether any business areas need more attention; Zook replied he saw no major surprises and reaffirmed confidence in the company's trajectory. Dan Brennan (TD Cowen): Requested details on full-year pharma headwinds and Pathline's contribution to Q2 guidance; CFO Jeff Sherman clarified pharma revenue is expected to decline, with Pathline adding $3–$4 million per quarter and ramping up in later quarters. Tejas Savant (Morgan Stanley): Inquired about capital deployment after paying down convertible notes, and the flexibility to invest in new product launches; Sherman stated cash flow will improve in 2026, providing options for the next round of debt. Matthew Sykes (Goldman Sachs): Probed the outlook for average revenue per test (AUP) amid Pathline integration; Sherman explained Pathline's lower AUP will dilute the blended metric, but core modalities are still seeing incremental gains. David Westenberg (Piper Sandler): Asked about the salesforce ramp and when new hires reach full productivity; Warren Stone said most additions are complete, with expected full productivity reached in six to nine months, pointing to late 2025 and early 2026 for maximum impact. In the coming quarters, the StockStory team will be watching (1) the commercial launch and physician adoption of PanTracer liquid biopsy and related NGS upgrades, (2) the pace and success of Pathline integration, including the rollout of NeoGenomics' test menu to new customers, and (3) progress on operating efficiencies and cost-saving initiatives as the expanded salesforce matures. Execution on partnerships, especially with Adaptive and Ultima Genomics, and visibility into non-clinical revenue stabilization will also be important indicators of strategic execution. NeoGenomics currently trades at a forward P/E ratio of 38×. Should you double down or take your chips? See for yourself in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today.
Business Wire
01-05-2025
- Business
- Business Wire
NeoGenomics Pays Off 1.25% Convertible Senior Notes
FORT MYERS, Fla.--(BUSINESS WIRE)-- NeoGenomics, Inc. ('NeoGenomics' or the 'Company') (NASDAQ: NEO), a leading provider of oncology testing services, today announced that it has paid off in full the remaining $201.25 million in principal amount outstanding of its 1.25% Convertible Senior Notes with a maturity date of May 1, 2025, using cash on hand. About NeoGenomics, Inc. 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 help them diagnose and treat cancer. 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 CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom.
