The Next Frontier in Single-Cell Genomics
Key Growth Drivers and Opportunities
rising Demand for Accurate and Personalized Medicine: Increasing demand for accurate and personalized drugs is a major driver of single-cell genome sequencing market, as this technique allows for detailed genetic analysis at the individual cell level-important to identify drugs goals and treatment reactions. Especially by enabling accurate diagnostics and sequential therapy in oncology, immunology and neurology, the single-cell sequencing supports more effective, changes towards patient-specific medical interventions, fueling its adoption in research and clinical settings.
Challenges
Despite its rapid growth, the single-cell genome sequencing faces several borders in the market, including the high cost of equipment and reagents, complex sample preparation protocols, and large-scale, data interpretations due to the noise dataset include challenges. Additionally, limited standardization in platforms and analytical devices may obstruct fertility and scalability, especially in clinical applications. These factors prohibit adoption widely, especially in low-resources settings and small research institutes.
Innovation and Expansion
Roche and Broad Clinical Labs Collaborate to Advance the Rollout of Next-Gen SBX Sequencing
In May 2025, Roche and Broad Clinical Labs established a collaborative partnership to create and test innovative applications utilizing Roche's recently introduced Sequencing by Expansion (SBX) next-generation sequencing (NGS) technology.
The goal of this partnership is to use SBX technology to revolutionize biomedical research and clinical genomics. Additionally, it will seek to make SBX technology a standard product for the research community at Broad Clinical Labs in terms of quick, scalable sequencing.
Ultima Genomics' UG 100TM Platform Partnership Increases Access to Inexpensive DNA Sequencing Worldwide
In February 2025, The UG100TM next-generation sequencing (NGS) platform's creator, Ultima Genomics, Inc., announced several new collaborations with top genomic services providers, expanding access to high-quality, reasonably priced DNA sequencing worldwide. In order to facilitate single cell sequencing, spatial transcriptomics, proteomics, whole genome sequencing, and other applications, this international network of renowned service providers will deliver industry-leading DNA sequencing services using the UG 100.
The Ontario Institute of Cancer Research, Novogene, Psomagen, Eurofins, and Broad Clinical Labs are among the top-tier companies that were revealed today. These partners join the University of Minnesota Genomics Center, Macrogen, and Inocras as current Ultima Genomics service provider partners.
Inventive Sparks, Expanding Markets
Key players operating in the single-cell genome sequencing include ThermoFisher Scientific, Inc., Illumina, Bio-Rad, BD, Pacific Biosciences of California, Inc., QIAGEN, 10X Genomics, Inc., BGI, Novogene Co. Ltd., NuGEN Technologies, Inc., Takara Bio, Inc., F Hoffmann-La Roche Ltd., Oxford Nanopore Technologies, Fludigim, and Agilent Technologies Inc.
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NeoGenomics Reports Second Quarter 2025 Results
FORT MYERS, Fla.--(BUSINESS WIRE)-- NeoGenomics, Inc. (NASDAQ: NEO) (the ' Company '), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced its second-quarter results for the period ended June 30, 2025. 'In the second quarter clinical revenue increased by 16% driven by sequential improvement in AUP, a record quarter for volumes, and NGS growth of 23%,' said Tony Zook, CEO of NeoGenomics. 'Strength in our Clinical business was largely offset by continuing pressure in pharma revenue that was beyond our initial assumptions, and a delay in our commercial launch of PanTracer™ Liquid Biopsy that impacted our expected NGS revenue.' 'Looking ahead, we believe Neo will continue to perform as a double-digit revenue growth company, poised to capture additional market share,' continued Mr. Zook. 'We are enhancing our R&D efforts to develop new therapy selection and next-gen MRD products. We are also preparing for the commercial launch of PanTracer Liquid Biopsy, continuing to grow our sales team, increasing efficiencies, and pursuing partnerships through business development efforts that will enhance our portfolio and strengthen our community channel. We are confident that Neo will deliver long-term value for our customers, patients, and shareholders.' Second-Quarter Results Consolidated revenue for the second quarter of 2025 was $181 million, an increase of 10% over the same period in 2024 primarily due to higher volume partially offset by lower non-clinical revenue. Average revenue per clinical test ('revenue per test') increased by 2% to $465. This increase reflects higher value tests, including NGS, and strategic reimbursement initiatives. Consolidated gross profit for the second quarter of 2025 was $77 million, an increase of 7% compared to the second quarter of 2024. This increase was primarily due to an increase in revenue partially offset by higher compensation and benefit costs and an increase in supplies expense. Consolidated gross profit margin, including amortization of acquired intangible assets and stock-based compensation expense, was 43%. Adjusted Gross Profit Margin (1), excluding amortization of acquired intangible assets and stock-based compensation expense, was 45%. Operating expenses for the second quarter of 2025 were $125 million, an increase of $30 million, or 32%, compared to the second quarter of 2024. The increase in operating expenses primarily reflect $20.0 million of impairment charges from impairment of assets held for sale related to the planned sale of Trapelo and the InVisionFirst®-Lung intangible asset impairments, as well as $4.4 million in higher compensation and benefit costs. These increases were partially offset by a decrease in restructuring activities due to the completion of restructuring activities in the fourth quarter of 2024. Net loss for the quarter increased $26 million, or 142%, to $45 million compared to net loss of $19 million for the second quarter of 2024. Adjusted EBITDA (1) for the second quarter of 2025 remained relatively flat at positive $10.7 million, compared to positive $10.9 million in the second quarter of 2024. Adjusted Net Loss (1) was $3.6 million compared to Adjusted Net Loss (1) of $4 million in the second quarter of 2024. Cash and cash equivalents and marketable securities totaled $164 million at quarter end. Pathline, LLC Acquisition On April 4, 2025, the Company completed the acquisition of a 100% ownership interest in Pathline, LLC ('Pathline'), a CLIA/CAP/NYS-certified laboratory based in New Jersey. The purchase price consisted of (i) initial cash consideration of $8.0 million, subject to working capital and other adjustments, and (ii) contingent consideration of $1.0 million. The Pathline acquisition aligns with the Company's strategic objective of expanding its presence, capabilities, and offerings in the Northeastern United States. 2025 Financial Guidance (2) The Company again revised its full-year 2025 guidance (2), as previously revised on April 29, 2025. ____________________ Expand (1) The Company has provided adjusted financial information that has not been prepared in accordance with GAAP, including Adjusted EBITDA, Adjusted Gross Profit Margin, Adjusted Net (Loss) Income, and Adjusted Diluted EPS. Each of these measures is defined in the section of this report entitled 'Use of Non-GAAP Financial Measures.' See also the tables reconciling such measures to their closest GAAP equivalent. (2) The Company reserves the right to adjust this guidance at any time. Current and prospective investors are encouraged to perform their own due diligence before buying or selling any of the Company's securities and are reminded that the foregoing estimates should not be construed as guarantees of future performance. Expand Conference Call The Company has scheduled a webcast and conference call to discuss its second quarter 2025 results on Tuesday, July 29, 2025 at 8:30 a.m. Eastern Time. To access the live call via telephone, interested investors should dial (888) 506-0062 (domestic) or (973) 528-0011 (international) at least five minutes prior to the call. The participant access code provided for this call is 859170. The live webcast may be accessed by visiting the Investor Relations section of our website at A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company's website. 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 a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. We routinely post information that may be important to investors on our website at 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. These forward-looking statements address various matters, including statements regarding 2025 financial guidance, seasonality impacts, and long-range strategic objectives and initiatives set forth in the Company's long-range plans.. 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 assemble and maintain an effective executive team, to continue gaining new customers, offer new types of tests, integrate its acquisitions, manage the effects of seasonality, execute on its long-range strategic priorities, and otherwise implement its business plans, and the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and filed with the SEC on February 18, 2025, as well as subsequently filed 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 and on our website 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. NeoGenomics, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, COST OF REVENUE 104,072 92,008 198,861 182,779 GROSS PROFIT 77,258 72,494 150,504 137,963 Operating expenses: General and administrative 71,747 63,328 139,954 129,125 Research and development 9,023 7,886 19,204 15,506 Sales and marketing 24,075 21,677 46,758 41,898 Restructuring charges — 1,544 — 3,942 Impairment charges 20,041 — 20,041 — Total operating expenses 124,886 94,435 225,957 190,471 LOSS FROM OPERATIONS (47,628 ) (21,941 ) (75,453 ) (52,508 ) Interest income (2,263 ) (4,592 ) (5,984 ) (9,426 ) Interest expense 933 1,666 2,551 3,351 Other (income) expense, net (482 ) 2 (547 ) 265 Loss before taxes (45,816 ) (19,017 ) (71,473 ) (46,698 ) Income tax benefit (724 ) (375 ) (458 ) (995 ) NET LOSS $ (45,092 ) $ (18,642 ) $ (71,015 ) $ (45,703 ) NET LOSS PER SHARE Basic $ (0.35 ) $ (0.15 ) $ (0.56 ) $ (0.36 ) Diluted $ (0.35 ) $ (0.15 ) $ (0.56 ) $ (0.36 ) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING Basic 127,949 126,405 127,664 126,257 Diluted 127,949 126,405 127,664 126,257 Expand NeoGenomics, Inc. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited) Six Months Ended June 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ (71,015 ) $ (45,703 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 18,506 19,651 Amortization of intangibles 16,486 16,723 Stock-based compensation 22,968 16,615 Non-cash operating lease expense 3,353 4,793 Amortization of convertible debt discount and debt issue costs 1,233 1,452 Impairment charges 20,041 — Other impairment charges — 333 Other adjustments (340 ) 159 Changes in assets and liabilities, net (16,229 ) (26,046 ) Net cash used in operating activities (4,997 ) (12,023 ) CASH FLOWS FROM INVESTING ACTIVITIES Proceeds from maturities of marketable securities 11,060 40,501 Purchases of property and equipment (10,823 ) (18,663 ) Business acquisition, net of cash acquired (5,991 ) — Net cash (used in) provided by investing activities (5,754 ) 21,838 CASH FLOWS FROM FINANCING ACTIVITIES Issuance of common stock, net (234 ) 2,782 Repayment of convertible debt (201,250 ) — Net cash (used in) provided by financing activities (201,484 ) 2,782 Net change in cash and cash equivalents, including cash classified within current assets held for sale (212,235 ) 12,597 Less: net change in cash classified within current assets held for sale (54 ) — Net change in cash and cash equivalents (212,289 ) 12,597 Cash and cash equivalents, beginning of period 367,012 342,488 Cash and cash equivalents, end of period $ 154,723 $ 355,085 Expand Use of Non-GAAP Financial Measures In order to provide greater transparency regarding our operating performance, the financial results and financial guidance in this press release refer to certain non-GAAP financial measures that involve adjustments to GAAP results. Non-GAAP financial measures exclude certain income and/or expense items that management believes are not directly attributable to the Company's core operating results and/or certain items that are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. Management believes that the presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors by facilitating the analysis of the Company's core test-level operating results across reporting periods. These non-GAAP financial measures may also assist investors in evaluating future prospects. Management also uses non-GAAP financial measures for financial and operational decision making, planning and forecasting purposes and to manage the business. These non-GAAP financial measures do not replace the presentation of financial information in accordance with U.S. GAAP financial results, should not be considered measures of liquidity, and are unlikely to be comparable to non-GAAP financial measures provided by other companies. Definitions of Non-GAAP Measures Non-GAAP Adjusted EBITDA 'Adjusted EBITDA' is defined by NeoGenomics as net (loss) income from continuing operations before: (i) interest income, (ii) interest expense, (iii) tax (benefit) or expense, (iv) depreciation and amortization expense, (v) stock-based compensation expense, and, if applicable in a reporting period, (vi) CEO transition costs, (vii) restructuring charges, (viii) impairment charges, (ix) intellectual property ('IP') litigation costs, and (x) other significant or non-operating (income) or expenses, net. Non-GAAP Adjusted Cost of Revenue, Adjusted Gross Profit and Adjusted Gross Profit Margin 'Adjusted cost of revenue' is defined by NeoGenomics as cost of revenue before: (i) amortization of acquired intangible assets, and, if applicable in a reporting period, (ii) stock-based compensation expense. 'Adjusted gross profit' is defined by NeoGenomics as total revenue less adjusted cost of revenue. 'Adjusted gross profit margin' is defined by NeoGenomics as adjusted cost of revenue divided by total revenue. Non-GAAP Adjusted Net (Loss) Income 'Adjusted net (loss) income' is defined by NeoGenomics as net (loss) income from continuing operations plus: (i) amortization of intangible assets, (ii) stock-based compensation expense, and, if applicable in a reporting period, (iii) CEO transition costs, (iv) restructuring charges, (v) impairment charges, (vi) IP litigation costs, and (vii) other significant or non-operating (income) or expenses, net. If GAAP net (loss) income is negative and adjusted net (loss) income is positive, adjusted net (loss) income will also be adjusted to reverse any recognized interest expense (including any amortization of discounts) on the convertible notes using the if-converted method unless the effect of this adjustment on both the adjusted net (loss) income and weighted average diluted common shares outstanding would be anti-dilutive. If GAAP net (loss) income is positive and adjusted net (loss) income is negative, adjusted net (loss) income will also be adjusted to reverse any recognized interest expense (including any amortization of discounts) on the convertible notes using the if-converted method. Non-GAAP Adjusted Diluted EPS 'Adjusted diluted EPS' is defined by NeoGenomics as adjusted net (loss) income divided by adjusted diluted shares outstanding. If GAAP net (loss) income is negative and adjusted net (loss) income is positive, adjusted diluted shares outstanding will also include any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period, until the effect of these adjustments are anti-dilutive. If GAAP net (loss) income is positive and adjusted net (loss) income is negative, adjusted diluted shares outstanding will exclude any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period. ____________________ Expand (1) For the three months ended June 30, 2025, CEO transition costs include executive retention costs. For the six months ended June 30, 2025, CEO transition costs include severance costs, executive retention costs, and executive search costs. There were no such costs for the three and six months ended June 30, 2024. (2) For the three and six months ended June 30, 2025, acquisition and integration related expenses include consulting and legal fees, severance costs, and employee retention costs. (3) For the three and six months ended June 30, 2025, impairment charges include losses from InVisionFirst®-Lung intangible asset impairment and inventory write-off, and impairment of disposal groups held for sale. There were no such costs for the three and six months ended June 30, 2024. (4) For the three and six months ended June 30, 2025 and June 30, 2024, IP litigation costs include legal fees. (5) For the three and six months ended June 30, 2024, other significant (income) expenses, net, includes site closure costs, severance costs, and fees related to non-recurring legal matters. There were no such costs for the three and six months ended June 30, 2025. Expand ____________________ Expand (1) Cost of revenue adjustments for the three months ended June 30, 2025, includes $4.8 million of amortization of acquired intangible assets and $0.3 million of stock-based compensation. Cost of revenue adjustments for the six months ended June 30, 2025, includes $9.7 million of amortization of acquired intangible assets and $0.7 million of stock-based compensation. Cost of revenue adjustments for the three months ended June 30, 2024, includes $4.9 million of amortization of acquired intangible assets and $0.3 million of stock-based compensation. Cost of revenue adjustments for the six months ended June 30, 2024, includes $9.8 million of amortization of acquired intangible assets and $0.7 million of stock-based compensation. Expand Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and GAAP EPS to Non-GAAP Adjusted EPS (in thousands, except per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net loss (GAAP) $ (45,092 ) $ (18,642 ) $ (71,015 ) $ (45,703 ) Adjustments to net loss, net of tax: Amortization of intangibles 8,124 8,361 16,486 16,723 CEO transition costs (1) 637 — 2,831 — Acquisition and integration related expenses (2) 3,204 — 4,376 — Stock-based compensation expense 12,215 8,841 22,968 16,615 Restructuring charges — 1,544 — 3,942 Impairment charges (2) 20,041 — 20,041 — IP litigation costs (3) 4,460 1,962 7,443 6,243 Other significant expenses, net (4) — 2,358 — 3,960 Adjusted net income $ 3,589 $ 4,424 $ 3,130 $ 1,780 Net loss per common share (GAAP) Diluted EPS $ (0.35 ) $ (0.15 ) $ (0.56 ) $ (0.36 ) Adjustments to diluted loss income per share: Amortization of intangibles 0.06 0.07 0.13 0.13 CEO transition costs (1) — — 0.02 — Acquisition and integration related expenses (2) 0.03 — 0.03 — Stock-based compensation expense 0.10 0.07 0.18 0.13 Restructuring charges — 0.01 — 0.03 Impairment charges (3) 0.16 — 0.16 — IP litigation costs (4) 0.03 0.02 0.06 0.05 Other significant expenses, net (5) — 0.02 — 0.03 Rounding and impact of diluted shares in adjusted diluted shares (6) — (0.01 ) — — Adjusted diluted EPS (non-GAAP) $ 0.03 $ 0.03 $ 0.02 $ 0.01 Weighted average shares used in computation of adjusted diluted EPS: Diluted common shares (GAAP) 127,949 126,405 127,664 126,257 Dilutive effect of options, restricted stock, and converted shares (7)(8) — — — — Expand ____________________ Expand (1) For the three months ended June 30, 2025, CEO transition costs include executive retention costs. For the six months ended June 30, 2025, CEO transition costs include severance costs, executive retention costs, and executive search costs. There were no such costs for the three and six months ended June 30, 2024. (2) For the three and six months ended June 30, 2025, acquisition and integration related expenses include consulting and legal fees, severance costs, and employee retention costs. (3) For the three and six months ended June 30, 2025, impairment charges include losses from InVisionFirst®-Lung intangible asset impairment and inventory write-off, and impairment of disposal groups held for sale. There were no such costs for the three and six months ended June 30, 2024. (4) For the three and six months ended June 30, 2025 and June 30, 2024, IP litigation costs include legal fees. (5) For the three and six months ended June 30, 2024, other significant (income) expenses, net, includes site closure costs, severance costs, and fees related to non-recurring legal matters. There were no such costs for the three and six months ended June 30, 2025. (6) This adjustment is for rounding and, in those periods in which GAAP net (loss) income is negative and adjusted net (loss) income is positive or GAAP net (loss) income is positive and adjusted net (loss) income is negative, also compensates for the effects of additional diluted shares included or excluded in adjusted diluted shares outstanding for the treasury stock impact of outstanding stock options and restricted stock and the if-converted impact of convertible notes. (7) In those periods in which GAAP net (loss) income is negative and adjusted net (loss) income is positive, this adjustment includes any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period, until the effect of these adjustments are anti-dilutive. (8) In those periods in which GAAP net (loss) income is positive and adjusted net (loss) income is negative, this adjustment excludes any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period. Expand Reconciliation of Non-GAAP Financial Guidance to Corresponding GAAP Measures (in thousands, except per share amounts) (unaudited) GAAP net loss in 2025 will be impacted by certain charges, including: (i) expense related to the amortization of intangible assets, (ii) stock-based compensation, and (iii) other one-time expenses. These charges have been included in GAAP net loss available to stockholders and GAAP net loss per share; however, they have been removed from adjusted net loss and adjusted diluted net loss per share The following table reconciles the Company's 2025 outlook for net loss and EPS to the corresponding non-GAAP measures of adjusted net loss, adjusted EBITDA, and adjusted diluted EPS: ____________________ Expand (1) This adjustment is for rounding and, in those periods in which GAAP net (loss) income is negative and adjusted net (loss) income is positive, also compensates for the effects of additional diluted shares included in adjusted diluted shares outstanding for the treasury stock impact of outstanding stock options and restricted stock and the if-converted impact of convertible notes. (2) For those periods in which GAAP net (loss) income is negative and adjusted net (loss) income is positive, this adjustment includes any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such shares would have been outstanding in the reporting period, until the effect of these adjustments are anti-dilutive. Expand Supplemental Information Clinical Tests Performed and Revenue (unaudited) ____________________ Expand (1) Excludes tests and revenue related to Pathline and non-clinical activity. (2) Excludes tests and revenue related to non-clinical activity. Expand
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These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer's across the entire patient journey. Featured oral presentations include the latest results from the ongoing Phase Ib/IIa Brainshuttle™ AD study, which continue to support rapid and robust reduction of amyloid plaques, and design of the Phase III TRONTIER 1 and 2 studies of investigational trontinemab for early symptomatic Alzheimer's disease, with initiation planned later this year. As part of its growing Alzheimer's development programme, Roche announced today its plans for an additional Phase III trial to investigate trontinemab in preclinical Alzheimer's disease. The trial will focus on individuals at risk of cognitive decline, with the goal of potentially delaying or preventing the progression of the disease to symptomatic stages. 'Alzheimer's disease represents one of the greatest challenges in healthcare today and tackling it requires early detection and effective therapeutics,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'Trontinemab is designed to target a key driver of Alzheimer's disease biology more effectively in the brain. Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention. With plans for Phase III trials in both early symptomatic and preclinical Alzheimer's disease, we are advancing science with the goal of delaying —and ultimately preventing—progression of this devastating condition.' Late-breaking oral and poster presentations highlight the potential of Roche's Elecsys® pTau217 as a reliable and accessible blood-based biomarker test, providing comparable results to PET scan and cerebrospinal fluid (CSF) diagnostics for rule-in and rule-out diagnosis of amyloid pathology, a hallmark of Alzheimer's disease, across care settings. The test, which received Breakthrough Device Designation from the U.S. Food and Drug Administration last year, will also be utilised in Roche's TRONTIER studies. 'Blood based testing for Alzheimer's disease has the potential to greatly improve patient access and decrease the time to definitive disease diagnosis,' said Matt Sause, CEO of Roche Diagnostics. 'Our data show that the Elecsys pTau217 test performs comparably to PET scans but can be performed with a simple blood draw and analyzed in a routine clinical laboratory. This has the potential to transform the diagnosis of Alzheimer's and provide clear answers to caregivers, patients, and their families.' Up to 75% of people living with symptoms of Alzheimer's disease globally have not been diagnosed, and those who have, waited an average of 2.8 years1, and even less have received any form of treatment. Diagnostics play a crucial role in addressing the global challenge of Alzheimer's, not only to detect and identify people with the disease early, even before the first symptoms, but also to rule out those who may or may not benefit from specific treatments. Pharmaceuticals In a 90-minute Featured Research session, designs were shared for the Phase III studies, TRONTIER 1 and 2, which will initiate later this year, investigating the efficacy and safety of investigational trontinemab in people with early Alzheimer's disease. The primary endpoint will measure the change in cognition and function based on the Clinical Dementia Rating – Sum of Boxes scale after 18 months of treatment. Secondary endpoints will include assessments of cognition, function, behavioural symptoms, and quality of life. A pre-screening study, TRAVELLER, based on a brief clinical assessment and a plasma biomarker, which will be identified using the Elecsys pTau217 test, has also been initiated, to enable broader community outreach and extend access to these trials to more diverse populations representative of Alzheimer's disease. New data on the latest results for trontinemab from the completed dose-expansion part of the 1.8 mg/kg and 3.6 mg/kg cohorts from the ongoing Phase Ib/IIa Brainshuttle AD study continued to show rapid and robust reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET). In the 3.6 mg/kg cohort, trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in 91% of participants (n=49/54) after 28 weeks of treatment; 72% (n=39/54) achieved deep clearance below 11 centiloids. These data were reinforced by early and significant reductions in fluid biomarkers of Alzheimer's disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in CSF and continues to show a favourable safety and tolerability profile. Amyloid-related imaging abnormalities-edema/effusion (ARIA-E) continued to be observed in <5% of participants (blinded data; N=4/149 across 1.8 and 3.6mg/kg dose cohorts). All cases were radiographically mild, one was associated with mild and transient symptoms. Diagnostics Roche will present data on a new study comparing the pTau217/Ab42 plasma ratio to the high-throughput, fully automated Elecsys pTau217 assay. The presentation will report on the accuracy of these tools in detecting amyloid pathology. Together with the high throughput and full automation of the assay, these data will assess the potential of Elecsys pTau217 as an accurate standalone rule-in and rule-out test that could be scaled up for broad implementation in routine clinical practice worldwide. Additionally, results from a cohort-based model of healthcare utilisation in the U.S. demonstrated that using the Elecsys® pTau181 blood-based rule-out test in primary care scenarios improved diagnostic accuracy and reduced resource use compared with the current standard-of-care clinical, cognitive and imaging tests. If made available in primary care settings, the Roche Elecsys® pTau181 blood test has the potential to reliably avoid the need for further confirmatory testing in nearly all people who receive a negative result. This will avoid the need for these people to undergo unnecessary testing using CSF or PET, which often come with long wait times and high cost, resulting in further delays to diagnosis and cost to healthcare systems. Medicine Abstract title Presentation number (type) Presentation date (session) Time Abstracts will be available on the AAIC website. Pharmaceuticals Next wave of innovation in Alzheimer's disease therapeutics: The value of novel active transport mechanisms Featured Research Session (FRS), Talk 1 Room 718 27 Jul 2025, 2pm – 3.30pm EDT Cath Mummery, Roberto Villaseñor, Jens Niewoehner, Scarlett Barker, Luka Kulic Latest results from the dose-expansion part (Part 2) of the Brainshuttle™ AD study of trontinemab in people with Alzheimer's disease Featured Research Session (FRS), Talk 2 Room 71827 Jul 2025, 2pm – 3.30pm EDT Luka Kulic, Fabien Alcaraz, Gregory Klein, Stephen Salloway, Carsten Hofmann, João A. Abrantes, Stella Yilmaz, Denise Sickert, Maddalena Marchesi, Jakub Wojtowicz, Andres Schneider, Ruth Croney, David Agnew, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel Interim biomarker results for trontinemab, a novel Brainshuttle™ antibody in development for the treatment of Alzheimer's disease Featured Research Session (FRS), Talk 3 Room 718 27 Jul 2025, 2pm – 3.30pm EDT Gregory Klein, Gil Rabinovici, Henrik Zetterberg, Matteo Tonietto, Tobias Bittner, Daria Rukina, Fabien Alcaraz, Carsten Hofmann, Maddalena Marchesi, Jakub Wojtowicz, Ruth Croney, David Agnew, João A. Abrantes, Franziska Schaedeli Stark, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel, Luka Kulic TRONTIER 1 and TRONTIER 2: Pivotal trials of trontinemab in early symptomatic Alzheimer's disease Featured Research Session (FRS), Talk 4 Room 71827 Jul 2025, 2pm – 3.30pm EDT Janice Smith, Catherine Mummery, Jeffrey L. Cummings, Gil Rabinovici, Stephen Salloway, Reisa Sperling, Henrik Zetterberg, Angeliki Thanasopolou, Christopher Lane, Paul Delmar, Gregory Klein, Ruth Croney, Jakub Wojtowicz, Carsten Hofmann, Luka Kulic, Hideki Garren Diagnostics Evaluating the Impact on Diagnostic Performance and Healthcare Resource Utilization of Introducing a plasma rule-out test in the Alzheimer's Disease Diagnostic Pathway Poster #102729 July 27, 7:30am- 4:15pm EDT Sophie Roth , Gustaf Ortsäter, Joana Amorim Freire Location tbc Evaluating the Clinical Performance of the Elecsys pTau217 Plasma Immunoassay to Detect Amyloid Pathology in a Routine Clinical Practice Cohort Poster #96679 July 28, 7:30 am – 4:15 pm EDT Sayuri Hortsch , Niels Borlinghaus, Alexander Jethwa, David Caley, Annunziata Di Domenico, Craig Ritchie Clinical performance and effect of pre-analytical variation of plasma pTau217 alone versus the plasma pTau217/Aβ42 ratio for the identification of amyloid pathology Oral Developing Topics #108585 3-23-DEV Developing Topics on Tau Biomarkers July 29, 2025: 2:00 PM – 3:30 PM Christopher M. Rank, Joana Amorim Freire, Alexander Jethwa, Annunziata Di Domenico, Christina Rabe, Marc Suárez-Calvet , Colin L. Masters, Tobias Bittner Accuracy of cerebrospinal fluid biomarker ratios to determine amyloid positron-emission tomography status: a diagnostic test accuracy meta-analysis Poster #100941 July 28, 7:30 am – 4:15 pm EDT Pablo Martinez-Lage, Eino Solje, Julian G. Martins, Sraboni Sarkar Equity in diagnosis through adequate clinical trial design in diagnostic performance studies Poster #102804 July 30, 7:30am-4:15pm EDT Imke Kirste , David Caley, Clara Quijano Rubio, Margherita Carboni Investigating Differences in Patients Enrolled in a Clinical Study Based on Referral Type Poster #108110 July 30, 7:30am-4:15pm EDT Sophie Roth , Laura Schlieker, Sayuri Hortsch, Joana Amorim Freire,David Caley About trontinemab Trontinemab is an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody specifically engineered for enhanced access to the brain to enable rapid reduction of amyloid in people with Alzheimer's disease. Trontinemab is designed for the efficient transport across the blood-brain barrier to target aggregated forms of amyloid beta and remove amyloid plaques in the brain. The uniqueness of trontinemab is based on Roche's proprietary Brainshuttle technology combining an amyloid beta-binding antibody with a transferring receptor (TfR1) shuttle module. As a result, high central nervous system (CNS) exposure of trontinemab may be achieved at low doses, leading to a rapid and deep amyloid clearance. Due to its unique properties, trontinemab might unlock the full potential of disease-modifying monoclonal antibodies by effectively penetrating the brain and potentially leading to slowing of disease progression. About Roche in Alzheimer's Disease With more than two decades of scientific research in Alzheimer's disease, Roche is working towards a day when we can detect and treat the disease early, in order to slow down, stop or even prevent its progression to preserve what makes people who they are. Today, the company's Alzheimer's disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer's disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer's community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References [1] Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: [email protected] Hans Trees, PhD Phone: +41 79 407 72 58 Sileia Urech Phone: +41 79 935 81 48 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 6367262 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: [email protected] Attachment Media Investor Release AAIC 2025 English Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
