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Caris Life Sciences Announces New Study Demonstrating the Power and Clinical Utility of its Caris Assure® Blood-Based Assay for Multi-Cancer Early Detection, Minimal Residual Disease and Therapy Selec
Caris Life Sciences Announces New Study Demonstrating the Power and Clinical Utility of its Caris Assure® Blood-Based Assay for Multi-Cancer Early Detection, Minimal Residual Disease and Therapy Selec

Malaysian Reserve

time08-07-2025

  • Health
  • Malaysian Reserve

Caris Life Sciences Announces New Study Demonstrating the Power and Clinical Utility of its Caris Assure® Blood-Based Assay for Multi-Cancer Early Detection, Minimal Residual Disease and Therapy Selec

Scientific Reports study validates the first multifunctional, AI-enabled blood-based assay to offer diagnostic, prognostic and predictive utility in a single assay. IRVING, Texas, July 8, 2025 /PRNewswire/ — Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, announced a landmark study published in Scientific Reports, a Nature journal, demonstrating the accuracy and clinical utility of the Caris Assure® blood-based biopsy assay across the cancer continuum. The Caris Assure® platform is a breakthrough single assay that combines comprehensive, highly sophisticated molecular profiling of all 23,000+ genes across DNA and RNA in plasma, setting a new blood-based testing standard and revolutionizing management of the cancer care journey. Additionally, Caris sequences DNA in the 'buffy coat,' the layer of centrifuged blood between the red blood cells and plasma, which contains white blood cells and platelets. Caris Assure combines Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with advanced machine learning on a single platform. Caris Assure® is currently used for therapy selection and is capable of enabling accurate early detection and highly sensitive disease monitoring. 'We designed Caris Assure® to be more than a liquid biopsy test. This assay takes advantage of advanced sequencing and computing technology to capture genetic information available from the whole exome and whole transcriptome from the tumor material circulating in the blood and DNA from the patient's white blood cells,' said David Spetzler, MS, PhD, MBA, President of Caris. 'This enables us to provide a very comprehensive individualized picture of a patient's specific disease state. This is the first time so much molecular information has been available from a single blood test, allowing for increased accuracy and additional insights to inform physicians in helping to make cancer care decisions.' The Caris Assure® liquid biopsy platform, powered by the Assure Blood-based Cancer Detection AI (ABCDai), was trained on over 376,000 whole exome and whole transcriptome tissue profiles and over 7,000 matched blood and tissue samples. In addition to therapy selection, the study validates the performance of Caris Assure® in: Multi-Cancer Early Detection (MCED): Achieved sensitivities of 83.1% to 95.7% across cancer stages I–IV at 99.6% specificity. Diagnostic Pathway Predictor: Accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model. MRD and Recurrence Monitoring: Demonstrated significant predictive power for recurrence, with hazard ratios of 33.4 (p < 0.005) for MRD and 4.39 (p = 0.008) for therapeutic monitoring. Caris Assure® does not require a prior tissue biopsy. Instead, its AI model identifies tumor-derived signals based on patterns learned from hundreds of thousands of tumors. This enables a tissue-agnostic, highly sensitive approach to cancer detection and monitoring. While Caris Assure® is currently commercially available for therapy selection in advanced cancers, this study lays the groundwork for expanding into early detection, MRD and therapeutic monitoring. Caris is actively pursuing reimbursement and regulatory pathways to bring these applications to market. 'This is more than a validation study; it is a blueprint for the future of cancer diagnostics,' added Spetzler. 'Our goal is to create a seamless ecosystem where patients and clinicians can rely on one platform throughout the entire cancer journey.' About Caris Life Sciences Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms at scale, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies, and high-performance computing provides a differentiated platform to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. The Scientific Report study is available on Forward Looking Statements:This press release contains forward-looking statements, within the meaning of the federal securities laws, about Caris Life Sciences and its business. Statements about the performance and accuracy of Caris Assure discussed in this press release are based on testing and analysis to date, as reflected in the publication discussed, and future results and performance may differ materially from these findings. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases forward-looking statements can be identified by words such as 'may,' 'will,' 'should,' 'would,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'potential,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or similar expressions. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: developments in the precision oncology industry; future financial performance, results of operations or other operational results or metrics; development, validation and timing of future solutions; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; our compliance with laws and regulations; and our ability to hire and retain key personnel as well as risks, uncertainties, and other factors described in the section titled 'Risk Factors' and elsewhere in the prospectus for our initial public offering filed with the Securities and Exchange Commission on June 20, 2025, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law. Caris Life Sciences Media: Corporate CommunicationsCorpComm@ Investor Relations:Narendra ChokshiSenior Vice President, Corporate Developmentnchokshi@

Caris Life Sciences raises $494M in IPO
Caris Life Sciences raises $494M in IPO

Axios

time18-06-2025

  • Business
  • Axios

Caris Life Sciences raises $494M in IPO

Caris Life Sciences, a cancer diagnostics and treatment biotech, raised $494 million in its IPO at $21 per share, above its previously planned $19 to $20 per share range. By the numbers: The offering values Caris at about $5.95 billion, based on outstanding shares, lower than its 2021 valuation of $7.83 billion. It is expected to begin trading Wednesday on the Nasdaq under CAI. BofA Securities, JPMorgan, Goldman Sachs and Citigroup are leading. Catch up quick: Caris set terms June 9, aiming to sell 23.5 million shares for $16 to $18 but raised its range on Monday, planning to raise $470.6 million at the high end. Caris last raised in 2021, snagging $830 million in a growth equity round led by Sixth Street. The latest: The company, with 1,700 employees, reported a net loss of $127 million on $120.9 million in revenue during Q1 of this year. That's an improvement from a net loss of $134.1 million on $80.7 million in revenue over the same period a year ago. Caris says it has more than 90 payer contracts and over 100 biopharma partners. Company founder and chairman David D. Halbert is slated to own nearly 44% of the company based on a public offering price of $19.50 per share, per the company's updated filing. State of play: Caris' IPO signals the public markets may be reopening to biotech companies, which have grappled with various headwinds this year, spooking generalist investors.

Caris Life Sciences files for $424M IPO
Caris Life Sciences files for $424M IPO

Yahoo

time10-06-2025

  • Business
  • Yahoo

Caris Life Sciences files for $424M IPO

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Precision medicine company Caris Life Sciences said Monday it expects to raise as much as $423.5 million in an initial public offering. The Irving, Texas-based company plans to list its common stock on the Nasdaq market under the symbol 'CAI,' offering 23.5 million shares at $16 to $18 each. Primarily focused on cancer, Caris' molecular profiling tools use artificial intelligence and machine learning algorithms to analyze disease for early detection, diagnosis, monitoring, therapy selection and drug development. Caris saw year-over-year revenue growth of about 50%, to $120.9 million, in the first quarter of 2025, driven primarily by its molecular profiling services, according to a securities filing. The company received Food and Drug Administration approval for its companion diagnostic test MI Cancer Seek in November. The test identifies cancer patients who may benefit from targeted treatments. Founded in 2008, Caris has identified about 915,000 unique pathogenic mutations to date, of which only about 17,000 were previously known, the company said in its filing. 'We can now identify a person's circulating pathogenic mutations and enable the design of a customized individualized therapy to that specific set of mutations,' David Dean Halbert, Caris founder and CEO, said in the filing. 'We believe this is going to create the opportunity for physicians to use our solutions to effectively prevent various chronic diseases before they ever get started at the earliest of stages.' In April, when the company closed a private funding round worth $168 million, it said it had raised a total of $1.86 billion in capital since 2018. Caris is among a handful of companies exploring a public offering in a medtech IPO market that's showing signs of emerging from a slump. Medical products supplier Medline has said it could go public, and Medtronic plans to separate its diabetes business into a standalone company, potentially through an IPO. Recommended Reading The medtech IPO window is finally open. Or is it? Sign in to access your portfolio

Caris Life Sciences Announces Launch of Initial Public Offering
Caris Life Sciences Announces Launch of Initial Public Offering

Yahoo

time09-06-2025

  • Business
  • Yahoo

Caris Life Sciences Announces Launch of Initial Public Offering

IRVING, Texas, June 9, 2025 /PRNewswire/ -- Caris Life Sciences® ("Caris"), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that it has launched the roadshow for its proposed initial public offering of its common stock. Caris has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") to offer 23,529,412 shares of its common stock to the public. In addition, Caris intends to grant the underwriters a 30-day option to purchase up to an additional 3,529,411 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The initial public offering price is expected to be between $16.00 and $18.00 per share. Caris has applied to list its common stock on the Nasdaq Global Select Market under the ticker symbol "CAI." BofA Securities, J.P. Morgan and Goldman Sachs & Co. LLC will act as lead book-running managers for the proposed offering. Citigroup will also act as a book-running manager for the proposed offering. TD Cowen, Evercore ISI and Guggenheim Securities will act as additional book-running managers for the proposed offering. BTIG and Wolfe | Nomura Alliance will act as co-managers for the proposed offering. The proposed offering will be made available only by means of a prospectus. Copies of the preliminary prospectus, when available, may be obtained from: BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255, Attention: Prospectus Department or by email: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email: prospectus-eq_fi@ or Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282 or by email: prospectus-ny@ A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Caris Life SciencesCaris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms at scale, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies, and high-performance computing provides a differentiated platform to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. Caris Life Sciences Media: Corporate CommunicationsCorpComm@ Investor Relations:Narendra ChokshiSenior Vice President, Corporate Developmentnchokshi@ View original content to download multimedia: SOURCE Caris Life Sciences 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

Sixth Street-backed Caris Life Sciences targets $5.3 billion valuation in US IPO
Sixth Street-backed Caris Life Sciences targets $5.3 billion valuation in US IPO

Yahoo

time09-06-2025

  • Business
  • Yahoo

Sixth Street-backed Caris Life Sciences targets $5.3 billion valuation in US IPO

(Reuters) -Cancer diagnostic firm Caris Life Sciences said on Monday it is targeting a valuation of up to $5.35 billion in its initial public offering in the United States. Irving, Texas-based Caris plans to raise up to $424 million by offering 23.5 million shares priced between $16 and $18 apiece. The IPO market is heating up as high-profile companies move ahead with their stock market listings in a calmer period after tariff-related volatility stifled deal activity earlier this year. In 2021, Caris raised $830 million at a $7.83 billion valuation in a funding round led by investment firm Sixth Street. Caris will trade on the Nasdaq under the symbol "CAI." BofA Securities, J.P. Morgan, Goldman Sachs, and Citigroup are the lead underwriters for the offering.

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