Thermo Fisher's (TMO) CDx Gets FDA's Nod for Synovial Sarcoma

Zacks08-13

Thermo Fisher Scientific TMO recently secured FDA’s 510(k) clearance for its SeCore CDx HLA A Sequencing System for use as a companion diagnostic (CDx) alongside Adaptimmune’s ADAP newly approved T-...

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The latter is the first engineered cell therapy for a solid tumor cancer approved in the United States and the first new therapy option in more than a decade for synovial sarcoma — a rare, soft tissue cancer that most commonly impacts young adults.The recent development will enhance Thermo Fisher’s Transplant Diagnostics business, which is part of the Specialty Diagnostics segment.TECELRA is approved for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are certain HLA  type positive and whose tumor expresses the MAGE-A4 antigen, as determined by FDA-approved or cleared CDx devices.With the approval of therapies like Tecartus, Yescarta and Kymriah, various companies have shifted their business model from the devel","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1815333072.USD":"THREADNEEDLE (LUX) GLOBAL FOCUS \"AUP\" (USD) INC","BK4504":"桥水持仓","LU0077335932.USD":"FIDELITY AMERICAN GROWTH \"A\" INC","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4548":"巴美列捷福持仓","ADAP":"Adaptimmune Therapeutics plc","LU1720051108.HKD":"ALLIANZ GLOBAL ARTIFICIAL INTELLIGENCE \"AT\" (HKD) ACC","LU2125909247.SGD":"Natixis Thematics Meta H-R/A SGD","LU1983299246.USD":"SCHRODER ISF HEALTHCARE INNOVATION \"A\" (USD) ACC","LU0187121727.USD":"FIDELITY SUSTAINABLE US EQUITY \"A\" (USD) INC","LU0238689110.USD":"贝莱德环球动力股票基金","LU1923622614.USD":"Natixis Thematics Meta R/A USD","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","LU2092937221.SGD":"Blackrock Circular Economy A2 SGD-H","LU1988902786.USD":"FULLERTON LUX FUNDS GLOBAL ABSOLUTE ALPHA \"I\" (USD) ACC","SLE":"Super League Gaming Inc.","IE00B19Z9505.USD":"美盛-美国大盘成长股A Acc","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) ACC","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","LU0266013472.USD":"AXA WF - Framlington Longevity Economy A Cap USD","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU1989772923.USD":"CPR Invest - Climate Action A2 Acc USD-H","BSX":"波士顿科学","LU1153585028.USD":"BGF GLOBAL LONG-HORIZON EQUITY  \"A4\" (USD) INC","LU0061474960.USD":"天利环球焦点基金AU Acc","LU0950375773.USD":"BNP PARIBAS SUSTAINABLE GLOBAL LOW VOL EQUITY \"C\" (USD) INC A","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","BK4534":"瑞士信贷持仓","LU1923622291.USD":"Natixis Thematics Safety R/A USD","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","TMO":"赛默飞世尔","LU0234572021.USD":"高盛美国核心股票组合Acc","BK4533":"AQR资本管理(全球第二大对冲基金)","MASI":"麦斯莫医疗","LU0353189763.USD":"ALLSPRING  US ALL CAP GROWTH FUND \"I\" (USD) ACC","LU0823417653.USD":"BNP PARIBAS SUSTAINABLE GLOBAL LOW VOL EQUITY \"C\" (USD) ACC","BK4082":"医疗保健设备","LU1923621640.USD":"Natixis Thematics Water R/A USD","LU2087625088.SGD":"ALLSPRING  US ALL CAP GROWTH \"A\" (SGDHDG) ACC","LU0345769128.USD":"NINETY ONE GSF GLOBAL EQUITY \"A\" (USD) ACC","LU0122379950.USD":"贝莱德世界健康科学A2","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU0316494557.USD":"FRANKLIN GLOBAL FUNDAMENTAL STRATEGIES \"A\" ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU1548497426.USD":"安联环球人工智能AT Acc","LU0345769631.USD":"NINETY ONE GSF GLOBAL EQUITY \"A\" (USD) INC","LU1718418525.SGD":"JPMorgan Investment Funds - Global Select Equity A (acc) SGD","PTRA":"Proterra Inc.","BK4581":"高盛持仓"},"translate_title":"Thermo Fisher(TMO)的CDx获得FDA批准用于滑膜肉瘤","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TMO":1,"ADAP":1,"BSX":1,"MASI":1,"SLE":1,"PTRA":1},"content_text":"Thermo Fisher Scientific TMO recently secured FDA’s 510(k) clearance for its SeCore CDx HLA A Sequencing System for use as a companion diagnostic (CDx) alongside Adaptimmune’s ADAP newly approved T-cell receptor (TCR) therapy, TECELRA (afamitresgene autoleucel). The latter is the first engineered cell therapy for a solid tumor cancer approved in the United States and the first new therapy option in more than a decade for synovial sarcoma — a rare, soft tissue cancer that most commonly impacts young adults.\nThe recent development will enhance Thermo Fisher’s Transplant Diagnostics business, which is part of the Specialty Diagnostics segment.\nNews in Detail\nTECELRA is approved for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are certain HLA (human leukocyte antigen) type positive and whose tumor expresses the MAGE-A4 antigen, as determined by FDA-approved or cleared CDx devices.\nCancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific HLA proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.\nImage Source: Zacks Investment Research\nWhile the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and can potentially play a role in many immune-mediated conditions. In this regard, TMO’s Transplant Diagnostics business leverages its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.\nThe company is thrilled to expand the labeling of the SeCore CDx HLA A Sequencing System to include TECELRA and support clinicians in identifying which patients may benefit from this first-of-its-kind treatment. The Thermo Fisher team is focused on evolving their understanding of the human immune system and how it might impact treatment options across the healthcare continuum. Partnering with innovative companies like Adaptimmune enables it to expand patient access to breakthrough treatments that improve quality of life.\nIndustry Prospects\nPer a Grand View Research report, the global T-Cell therapy market was valued at $2.83 billion in 2022 and is expected to witness a CAGR of 35.3% up to 2030.\nWith the approval of therapies like Tecartus, Yescarta and Kymriah, various companies have shifted their business model from the development of small molecule and protein-based treatments to adoptive therapies. This factor has led to increased strategic investments by private as well as public agencies in the arena, boosting market growth. Furthermore, the rise in product approval, along with increasing manufacturing capacities, is expected to boost the market competition in T-cell therapy entities in the coming years.  \nRecent Developments in the Specialty Diagnostics Division\nLast month, Thermo Fisher introduced a new pre-transplant risk assessment assay via its CLIA laboratory in Fishers, Ind., that helps assess the risk of early acute rejection in kidney transplant recipients, providing data that may inform a more personalized approach to post-transplant immunosuppression management. The One Lambda Pre-Transplant Risk Assessment (PTRA) Assay is the first test of its kind to provide a risk score for early acute rejection based on a patient’s unique gene profile before transplant.\nAdditionally, the company also received the FDA’s extended 510(k) clearance to market its Optilite Freelite assays claim for the evaluation of monoclonal gammopathy of undetermined significance (MGUS). The assays previously received 510k clearance, following the FDA’s requirements, for the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE).\nPrice Performance\nIn the past year, TMO shares have rallied 10.8% compared with the industry’s rise of 5.4%.\nZacks Rank and Key Picks\nThermo Fisher currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the broader medical space are Masimo MASI and Boston Scientific BSX. While Masimo sports a Zacks Rank #1 (Strong Buy), Boston Scientific carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.\nMasimo shares have risen 13.2% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.\nMASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.\nEstimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 47.9% in the past year compared with the industry’s rise of 5.6%.\nBSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nBoston Scientific Corporation (BSX) : Free Stock Analysis Report\nThermo Fisher Scientific Inc. (TMO) : Free Stock Analysis Report\nMasimo Corporation (MASI) : Free Stock Analysis Report\nAdaptimmune Therapeutics PLC (ADAP): Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2459901452"}